Alat Alat Erweka PDF
Alat Alat Erweka PDF
Alat Alat Erweka PDF
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Dissolution
1
Dissolution Systems
UV-VIS In- or Online System (analysis only) .......................................................39
1. Sample transfer pump IPC 8 ........................................................................................ 39
2. UV-VIS Spectrophotometers ........................................................................................ 39
3. System control .............................................................................................................. 40
3.1. Disso.Net software
3.2. Driver for Agilent 8453
4. System tubing ............................................................................................................... 40
5. System pre-configuration ............................................................................................. 40
6. Computer ...................................................................................................................... 40
Options ............................................................................................................................. 41
UV-VIS On-/Offline Systems (storage, media replacement, dilution,UV-VIS analysis) .............42
1. Sample transfer pump .................................................................................................. 42
1.1. ERWEKA IPC 8
1.2. ERWEKA PVP 720/820
2. UV-VIS Spectrophotometers ........................................................................................ 43
3. Autosampler, FRL 820 ................................................................................................. 44
4. System control .............................................................................................................. 44
5. System tubing ............................................................................................................... 44
6. System pre-configuration ............................................................................................. 44
7. Computer ...................................................................................................................... 44
UV-VIS Dual Online Systems (analysis for 2 independent DT's) ..................................45
1. 2x sample transfer pump, IPC 8 ................................................................................... 45
2. UV-VIS Spectrophotometers ........................................................................................ 45
3. System control .............................................................................................................. 45
4. System tubing ............................................................................................................... 45
5. System pre-configuration ............................................................................................. 45
6. Computer ...................................................................................................................... 46
Options ............................................................................................................................. 46
Half Automated Dissolution System HADs ...............................................47
1. Dissolution Tester/s ...................................................................................................... 48
2. Video Monitoring/ Recording ........................................................................................ 48
3. Filtration ........................................................................................................................ 48
4. Sample Transfer Pump ................................................................................................ 49
5. HADs-HPLC/UV-VIS-Module ....................................................................................... 49
Dissolution Accessories
Vessels for Dissolution ...............................................................................51
Plastics ............................................................................................................................. 51
Glass ................................................................................................................................ 51
UV-resistant glass ............................................................................................................ 51
Conversion Kit for 250 ml vessel ...................................................................................... 51
Stirring Elements for UniShaft System ......................................................52
Basket Holders ................................................................................................................. 52
Baskets ............................................................................................................................. 54
Paddles and Discs USP apparatus 2 and 5 ...............................................53
Paddle UniShaft ............................................................................................................... 53
Paddle over Disc UniShaft ............................................................................................... 54
2
Rotating Cylinders USP apparatus 6 UniShaft ..........................................54
Enhancer Cell ................................................................................................................... 54
Extraction Cell .................................................................................................................. 54
Felodipine Basket ............................................................................................................. 55
Instrinsic Dissolution (Wood Apparatus) .......................................................................... 55
Filters for manual and automated sampling .............................................55
Manual sampling manifold ..........................................................................56
Sinkers..........................................................................................................56
Qualification .................................................................................................57
Qualification documents for Dissolution Testers and Dissolution Systems ..................... 57
USP Reference Standards ............................................................................................... 57
Qualification tools for Dissolution Testers ....................................................................................... 57
3
Disintegration Testers
ERWEKA ZT 220 series ...............................................................................73
1 test station, type ZT 221 ................................................................................................ 73
2 test stations, type ZT 222 .............................................................................................. 73
3 test stations, type ZT 223 .............................................................................................. 73
4 test stations, type ZT 224 .............................................................................................. 73
ERWEKA ZT 320 series ...............................................................................75
1 test station, type ZT 321 ................................................................................................ 75
2 test stations, type ZT 322 .............................................................................................. 75
3 test stations, type ZT 323 .............................................................................................. 75
4 test stations, type ZT 324 .............................................................................................. 75
Qualification .................................................................................................77
ERWEKA PQ tablets
Qualification tools for Disintegration Testers
4
Powder & Granulate Testers - Bulk Density
ERWEKA GTL...............................................................................................96
Options ............................................................................................................................. 96
ERWEKA GT .................................................................................................96
Options ............................................................................................................................. 96
ERWEKA GTB ..............................................................................................97
Options ............................................................................................................................. 97
ERWEKA SMG..............................................................................................97
Qualification .................................................................................................97
Qualification documents for Granulate-Flow Testers ....................................................... 97
Qualification tools for GT/B series .................................................................................... 97
Suppository Testers
ERWEKA Suppository Hardness Tester, type SBT 2 .................................................... 100
ERWEKA Suppository Melting Point Tester, type SSP ................................................. 100
ERWEKA Circulation Heater, EST 2 .............................................................................. 100
ERWEKA Suppository Penetration Tester, type PM 30 ................................................. 100
ERWEKA Suppository Disintegration Tester, type ST 32 .............................................. 101
ERWEKA Suppository Disintegration Tester, type ST 35 .............................................. 102
All-Purpose-Equipment
1. Motors .....................................................................................................103
1.1. AR 403 .................................................................................................................... 103
1.2. AR 403-S ................................................................................................................. 103
1.3. AMD......................................................................................................................... 103
Options for AR 403/-S and AMD .................................................................................... 103
5
Filling and Dosing Machine for Ointments and Crèmes, FDS ...................................... 105
Ball Mills, KM .................................................................................................................. 106
Double Cone Mixer, DKM............................................................................................... 106
Drum Hoop Mixer, RM .................................................................................................... 106
Y-Blender, YB 5 .............................................................................................................. 106
Vibration Sieve Shaker, VT ............................................................................................ 107
Sieve Sets ...................................................................................................................... 107
Coating Pan DKE/DKS ................................................................................................... 107
Polishing Drum ............................................................................................................... 108
Wet Granulator, FGS ...................................................................................................... 108
Dry Granulator, St. Steel, TG 2000 ................................................................................ 108
Pelletiser, GTE ............................................................................................................... 108
Cube Mixers, KB ............................................................................................................ 109
High Speed Mixer, SW 1/S............................................................................................. 109
Conical Mill, CM 60/UD .................................................................................................. 109
Tablet Presses
Single Punch Tablet Press, EP-1 ..............................................................110
Options ............................................................................................................................ 110
16-Station Rotary Tablet Press, ERWEKA TR-B 16 ................................111
Options for TR-B 16 ...................................................................................................... 111
8-Station Rotary Tablet Press, ERWEKA TR-D 8 ....................................112
Options for TR-D 8 ........................................................................................................ 112
Instrumentation of TR-B 16 / TR-D 8 ........................................................113
Roller Compactor RCC 100 x 20 Pharma .................................................114
Fluid Bed system FB 05 ............................................................................115
Services
Installation ...................................................................................................................... 118
Qualification .................................................................................................................... 118
Calibration ...................................................................................................................... 119
Maintenance ................................................................................................................... 119
Leasing ........................................................................................................................... 119
Used Equipment ............................................................................................................. 119
6
Examples for ordering
1. ERWEKA Friability-/Abrasion Tester with two test stations (230V/50Hz), Friability Drum left
with certificate, Abrasion Drum right without certificate, USB interface and Qualification docu-
ment (IQ/OQ/PQ)
2. ERWEKA Dissolution Tester, Type DT 626 Low Head, with 6 test stations (1.000 ml),
230V/60Hz, with automatic USP sampling station (Teflon tubing 3.0 mm o.d.)
14-060-6001 ERWEKA DT 626 LH, 230V/60Hz with glass vessels and paddles
14-06x-xx1x USB printer interface (PCL 3/5) for hard-copy documentation of test-
run parameters, calibration routines etc. Upgraded electronics (real
time watch) and instrument menu (printer settings, time/date settings
etc.)
14-060-6011 ERWEKA DT 626 (230V/60Hz) with automatic USP sampling sta-
tion and centering tools made of st.steel
3. ERWEKA Disintegration Tester ZT 320 Series with 1 Test Station, 115V/60Hz, USB interface,
2 spare part kits for USP basket rack assembly, Qualification document (IQ/OQ/PQ) and
Qualification tool kit in certified version.
7
Dissolution Tester (USP apparatus 1, 2, 5 and 6)
ERWEKA DT 820
6, 7 and 8 stirrer type
8
ERWEKA DT 826 Shaft Systems
6 test stations, 2 reference positions
DT 820 is available with UniShaft system for
For 6 stirring elements and screw connection.
holding 8x1000 ml vessel
The systems comprise of
an upper Shaft (inside the
230V/50-60Hz 14-080-6001 drive head) and a lower
115V/60Hz 14-080-6003 shaft to which the paddle
127V/60Hz 14-080-6004 or basket holder, trans-
dermal cylinder is con-
ERWEKA DT 827 nected.
7 test stations, 1 reference position The UniShaft system can
be ordered for both, Low-
For 7 stirring elements and Head and High-Head use and the test start can
holding 8x1000 ml vessel; be performed simultaneous or staggered.
Additional price
While the upper shaft is generally made from
230V/50-60Hz 14-080-7001 stainless steel the lower parts is mould from
115V/60Hz 14-080-7003 Teflon with an integrated stainless steel core.
127V/60Hz 14-080-7004 On special request stainless steel stirring ele-
ments are available.
ERWEKA DT 828 All parts are numbered and optionally come
8 test stations with a certificate of USP/EP compliance.
Funnel
With extension (plastics) for entering gran-
ules/powders and/or adding buffer solution
through the sampling openings (Low-Head
mode) 84-060-1500
9
Sample Withdraw Systems Cleaning reservoir (acrylic glass) with 3
separate compartments for cleaning of DT
Prepared for upgrade to Sampling Station 820/720 sampling stations. The 3 com-
(without automated sampling station) partments eliminate any possibility of con-
14-x8x-x1xx tamination (carry-over) 80-089-0000
10
ERWEKA DT 720
6, 7 and 8 stirrer type
ERWEKA DT 720 has been designed with the Corrosion-free plate for holding the vessels
user in mind: instead of an extensive operation Evaporation less than 0.3% in low-head
menu structure and multi-functional keys the DT mode and less than 0.7% in high-head
720 comes with individual displays for each mode (24h/37.0°C)
test-run parameter (time, rpm, temperature). External heating system with control by the
UP/DOWN buttons for fast and easy test-run keypad and LE display of the DT 720; ac-
parameter setting are placed. For better obser- curacy ± 0.2°C
vation of the sample dissolving process the Standard tablet drop magazine for 8
one-piece moulded water bath (with standard samples. Optional automatic tablet drop
water outlet cock) is illuminated (optional). with control of temperature tolerance
The manual lifter column, with hydraulic support (USP) before drop
for effortless operation, allows raising and low- Internal PT 100 temperature sensor for
ering of the drive head in just a few seconds. water bath temperature display
Tablets/Pellets etc. are inserted through the Optional external PT 100 temperature sen-
sampling openings in the drive head via the sor for water bath- or media temperature
standard tablet delivery system. Samples for display
analysis are withdrawn through special, mem- Optional monitoring of the media tempera-
brane sealed sampling openings inside the tures by electronic PT 100 temperature
drive head. Evaporation less than 0.3% in Low sensors
Head mode and less than 0.7% in High Head Calibration menu for quick calibration of
mode (24h/37.0°C). the 1 or 9 temperature sensors
The extensive use of carbon fibre allowed to Shaft wobble less than 0.2 mm at delivery
eliminate metal and therefore reduces the risk Height adjustable feed for levelling
of corrosion to a minimum. Automatic self-check of the temperature in
The actual test-run parameters can be docu- the bath/vessels before test start
mented via an USB printer (optional). Hours of operation counter
RS 232 serial interfaces for external con-
Easy and comfortable operations: trol
UP/DOWN and START/STOP buttons for Optional USB printer interface for docu-
test parameter setting as well as individual mentation of the test run parameters (time,
big and bright LE displays for display date, rpm, temperatures etc.) by a stan-
Manual Lifter with hydraulic support dard printer (PCL 3 language)
Low-Head and High-Head operations Optional USP sampling station with auto-
Quick exchange system for the stirring matic height adjustment of the USP sam-
methods pling points – to create a dissolution sys-
Automatic height adjustment of the stirring tem
elements Optional video monitoring of six test posi-
Automatic vessel centring tions in time laps mode
One-piece leak-free moulded, illuminated
(optional) water bath with outlet cock
11
ERWEKA DT 726 Shaft Systems
6 test stations, 2 reference positions
DT 720 is available with
For 6 stirring elements UniShaft system for screw
and holding 8x 1000 ml connection.
vessel
The systems comprise of
230V/50-60Hz 14-070-6001 an upper Shaft (inside the
115V/60Hz 14-070-6003 drive head) and a lower
127V/60Hz 14-070-6004 shaft to which the paddle
or basket holder, trans-
ERWEKA DT 727 dermal cylinder is con-
nected.
7 test stations, 1 reference position
The UniShaft system can be ordered for both,
For 7 stirring elements Low-Head and High-Head use and the test start
and holding 8x 1000 ml can be performed simultaneous or staggered.
vessel; Additional price
230V/50-60Hz 14-070-7001 While the upper shaft is generally made from
115V/60Hz 14-070-7003 stainless steel the lower parts is mould from
127V/60Hz 14-070-7004 Teflon with an integrated stainless steel core.
On special request stainless steel stirring ele-
ments are available.
ERWEKA DT 728
8 test stations All parts are numbered and optionally come
with a certificate of USP/EP compliance.
For 8 stirring elements
and holding 8x 1000 ml
vessel; Additional price Options
230V/50-60Hz 14-070-8001
115V/60Hz 14-070-8003 Automated, simultaneous, tablet drop
127V/60Hz 14-070-8004 magazine; Samples are automatically
dropped when temperature within the USP
specified range. Staggered tablet drop is
possible (manually) 84-070-0010
2000 ml Version
For holding ERWEKA USP compliant 2000 ml External electronic temperature sensor PT
vessels; water bath made from acrylic glass 100 for display of water bath - or media
instead mould PET water bath. For UniShaft temperature. Extended instrument menu for
only (High-Head and/or Low-Head configura- one-point calibration routine as well as cali-
tion). Additional price 14-1xx-xxxx bration hard-copy documentation (when
equipped with USB printer interface)
84-070-0100
12
Funnel Additional price for double
filtration station for holding
With extension (plastics) for entering gran- membrane filters
ules/powders and/or adding buffer solution 84-070-0955
through the sampling openings (Low-Head
mode) 84-060-1500
Titanium sampling- and replacement
probes (corrosion-free) instead of stainless
steel probes, at additional cost
Sample Withdraw Systems 80-090-0200
Prepared for upgrade to Sampling Station Cleaning reservoir (acrylic glass) with 3
(without automated sampling station) separate compartments for cleaning of DT
14-x8x-x1xx 720/820 sampling stations. The 3 com-
partments eliminate any possibility of con-
Additional Sampling Station with stainless tamination 80-089-0000
steel sampling- and replacement tubes,
Teflon tubing, without motor, for use with
sampling station drive. 84-070-0115
Spare Part Kits
USP/EP/JP
compliant Sam- Spare part kit for DT 720 comprising of 1
pling Station with paddle with shaft, 1 centring ring, 1 vessel
automatic height 1000ml, 1 belt, 2 fuses, 1 stirrer
adjustment of the 16 USP sampling 94-070-0001
heights. Teflon Tubing 1.6 mm o.d.
14-x8x-x2xx Spare part kit for DT 720 with automatic
USP Sampling Station comprising of spare
USP/EP/JP part kit 94-070-0001, 2 st.steel sampling
compliant Sam- probes, 2 st.steel return probes and 8 tube
pling Station with connectors 94-070-0002
automatic
height adjustment of the 16 USP sampling
heights. Teflon Tubing 3.0 mm o.d. Spare part kit for DT 720 with automatic
14-x8x-x4xx USP Sampling Station and 8 temperature
sensor option, incl. 94-070-0002
with 8 additional 94-070-0003
electronic PT 100
temperature sen-
sors for display
and documen-
tation of the media temperatures in all ves-
sels, incl. automatic USP Sampling Sta-
tion, Teflon Tubing 1.6 mm o.d.
14-x8x-x6xx
with 8 additional
electronic PT 100
temperature sen-
sors for display
and documen-
tation of the media temperatures in all ves-
sels, incl. automatic USP Sampling Sta-
tion, Teflon Tubing 3.0 mm o.d.
14-x8x-x9xx
13
Vessel Centring Rings
Vessel-Centring-Ring and Down-Holding-
Ring; for all kind of 1000 ml ERWEKA
Vessels 84-060-3000
Vessel Covers
V-Shaped vessel
covers made of
Teflon (instead
plastics) for even
lower evaporation.
84-060-0001
Low-Evaporation
Vessel-Cover (1000 ml
ERWEKA Vessel) for
High-Head use; addi-
tional To standard V-
shaped Vessel-Cover
84-000-0310
14
ERWEKA DT 1420
12, 13 and 14 stirrer type
ERWEKA DT 1420 is based on DT 720 user Height adjustable feed for levelling
interface (DT 1420i is based on DT 820 user Automatic self-check of the temperature in
interface), but fitted with 14 vessels arranged in the bath/vessels before test start
two rows (12, 13 or 14 stirrers). Hours of operation counter
The DT 1420 offers the possibility for one test USB interface for external control
with 12/13/14 tablets or two tests with 6/7 tab- Optional USB printer interface for docu-
lets. This enables the user to carry out stage 2 mentation of the test run parameters (time,
USP tests within one bath at equal test condi- date, rpm, temperatures etc.) by a stan-
tions. dard printer (PCL 3 language)
15
Water Stabiliser with colour
Shaft Systems
indicator, 1 bottle
UniShaft 80-080-0002
DT 1420 is available with
UniShaft system for screw
connection.
Automated Tablet Drop Magazine with Cleaning Reservoir for sampling station; with
temperature control before drop. All sam- 3 compartments to avoid any cross con-
ples will be dropped simultaneously tamination 80-089-0001
84-070-0100
16
Vessel Support Plate
Vessel Support Plate (plastics) with bayo-
net openings for Vessel-Centring-Rings for
ERWEKA Vessels 84-060-1000
Vessel Covers
V-Shaped vessel
covers made of Tef-
lon (instead plastics)
for even lower
evaporation.
84-060-0001
Low-Evaporation
Vessel-Cover (1000
ml ERWEKA Vessel)
for High-Head use;
additional to stan-
dard V-shaped Ves-
sel-Cover
84-000-0310
17
ERWEKA DT 620 High-Head
6 stirrer type, 1000 and 2000 ml ver-
sion
18
Options Vessel Support Plate
External electronic temperature sensor PT Vessel Support Plate (plastics) with bayo-
100 for display of water bath - or media net openings for Vessel-Centring-Rings for
temperature 84-070-0100 ERWEKA 1000 and 2000 ml Vessels
84-060-1000
USB printer interface 14-07x-xx1x
Vessel Covers
Illumination of the water bath by LEDs
14-090-6001 Low-Evaporation
Vessel-Cover (1000
Sampling and ml and 2000 ml
replacement ERWEKA Vessel)
probes (set of 6
probes, st.steel), 84-000-0310
fix in the media,
manual height ad-
justment. Teflon
tubing 1.6 or 3.0 Paddles, Baskets, Discs for Paddle over
mm outside diame- Disc, Rotating Cylinder and Glassware
ter (High-Head please see Accessories.
version 1000 ml
only)
14-06x-x6xx
19
Components, Pumps
1. Sample Transfer Pump Pump tubing’s are made of Verderprene (simi-
lar to Teflon) to prevent the absorption previ-
1.1. Transfer Pump IPC 8 ously associated with peristaltic pumps and
(8-channel Peristaltic Pump) PVC tubing.
20
2. Autosampler
2.1. Autosampler, FRL 720
Valve-free Autosampler for 7-, 8 or 14
channel operation
The 7-channel FRL 720 with x/y-driven sam- accuracy of ± 0.1 ml. Therefore, in combination
pling arm was designed for silent operation and with 10 ml or 25 ml glass tubes, a 1:1, 1:2, 1:5
maximum corrosion resistance. or even 1:10 dilution can be obtained.
To archive that the unit is mainly made from While in combination with a syringe pump the
corrosion free materials such as alloy and plas- precise dosing of the collected sample is ar-
tics and features a gentle and precise spindle chived by the syringe, at the “BUDGET” and
drive. “BASE” Offline Systems (peristaltic pump) the
FRL 720 is responsible for the dosing accuracy
The alloy rack-holder is made to carry various
itself: the glass tubes are overfilled with media –
racks (glass tubes of 10 ml and 25 ml capacity
then the stainless steel filling tubes move down
as well as HPLC vials of 1.5 ml and 4.0 ml
to the height level of the desired sample
maximum volume) to store max. 25 sampling
amount and returns the sample above this level
intervals of 8 vessels or 12 sampling intervals of
back to the vessel inside the dissolution tester.
14 test stations (FRL 720-2 version to operate
15-207-1000
with DT 1420). For temperature sensitive sam-
ples a cooled rack for HPLC vials is available.
HPLC membrane piercing is realised by using a Additional price 8-channel version, FRL 820
nd
2 spindle drive of the y-axis of the sampling 15-208-1000
arm. The high-torque gear allows piercing of
either split- or even none-split septum. Additional price 14-channel version,
FRL 720-2 15-214-1000
The medium replacement (if equipped) is per-
formed by a 2-part container of which the re- Additional price media replacement (incl. two
placement media section is constantly refilled 1-channel peristaltic pumps, 2-part acrylic
by two 1-channel peristaltic pumps from an glass container and replacement routine)
external heated or unheated flask. This feature 15-2xx-x1xx
permits a) nearly unlimited amount of replace-
ment media and b) sucking from a heated con- Additional price media replacement and
tainer not to lower the media temperature inside automated dilution (incl. two 1-channel peri-
the test station by cold replacement media. staltic pumps, 3-part acrylic glass container
and replacement-/dilution routine)
In standard configuration the 7 filling-tubes are 15-2xx-x2xx
made of 316 stainless steel but also are avail-
able from Titanium to eliminate any possibility Additional price for Titanium filling tubes
of corrosion even inside the tubes. (instead 316 stainless steel); for FRL 720
15-207-xx1x
For 8-channel operation the FRL 820, for 14-
channel operation the FRL 720-2 are available. Additional price for Titanium filling tubes
(instead 316 stainless steel); for FRL 820
In combination with an ERWEKA SP syringe
15-208-xx1x
pump and an optional 3-part container (instead
standard 2-part) the Autosampler 720 allows
Additional price for Titanium filling tubes
dilution of the collected samples with an
(instead 316 stainless steel); for FRL 720-2
15-214-xx1x
21
2.2. Autosampler, FRL 724
7-, 8- or 14-channel Autosampler with in-
tegrated valves
The 7-channel FRL 724 – with one solenoid arm. The high-torque gear allows piercing of
3-way-valve per channel and x/y-driven sam- either split- or even none-split septum.
pling arm – was designed for silent operation
and maximum corrosion resistance in combina- The medium replacement (if equipped) is per-
tion with either the peristaltic- or piston pump formed by a 2-part container of which the re-
for “stirrer type” dissolution testers as well as in placement media section is constantly refilled
combination with an USP 4 Offline system. by two 1-channel peristaltic pumps from an
external heated or unheated flask. This feature
To archive silent operation as well as corrosion permits a) nearly unlimited amount of replace-
resistance, the unit is mainly made from corro- ment media and b) sucking from a heated con-
sion free materials such as alloy and plastics tainer not to lower the media temperature inside
and features a gentle and precise spindle drive. the test station by cold replacement media.
15-207-2000
The integrated 3-way solenoid valves, in com-
bination with a “stirrer-type” dissolution system
allow accurate dosing (± 0.5 ml) when using Additional price 8-channel version, FRL 824
peristaltic- or piston pump. The medium is 15-208-2000
pumped in a close loop from the vessel back to
the vessel until the tubing is completely filled Additional price 14-channel version,
and only then the valve switched to collect the FRL 724-2 15-214-2000
sample into glass tubes or HPLC vials.
In combination with an USP 4 “Flow-Through- Additional price media replacement (incl. two
Cell” Offline System the 3-way-valves operate 1-channel peristaltic pumps, 2-part acrylic
as a “splitter” to collect an average of the flow- glass container and replacement routine)
through. The spindle drive, especially with USP 15-2xx-x1xx
4 systems, is a big advantage since the arm of
the Autosampler can be precisely moved from Additional price for Titanium filling tubes
row to row without returning to the zero-position (instead 316 stainless steel); for FRL 724
in between. 15-207-xx1x
The alloy rack-holder is made to carry various Additional price for Titanium filling tubes
racks (glass tubes of 10 ml and 25 ml capacity (instead 316 stainless steel); for FRL 824
as well as HPLC vials of 1.5 ml and 4.0 ml 15-208-xx1x
maximum volume) to store max. 25 sampling
intervals of 8 vessels or 12 sampling intervals of Additional price for Titanium filling tubes
14 test stations (FRL 724-2 version to operate (instead 316 stainless steel); for FRL 724-2
with DT 1420). For temperature sensitive sam-
ples a cooled rack for HPLC vials is available.
22
Options 3.1. Filter Changer, AFC 825
(8-channel membrane filter changer)
2.3 Racks for Autosampler
23
4. Automatic pH Changer, 7. System Software
AMC-A
Disso.net (UV-VIS Online, Perkin Elmer,
Agilent 8435, Analytic Jena Specord and
Shimadzu) 51-203-0000
8. UV-VIS Spectrophotometer
(only)
6. Computer
PC with 17” TFT monitor, colour printer etc.
70-203-5555
24
70-207-9001 11. Valve Box
Agilent 8453,
Dissolution-ready Valve Box for UV-VIS On-/Offline
230V/50Hz 80-206-0001
230V/60Hz 80-206-0002
115V/60Hz 80-206-0003
70-208-9000 127V/60Hz 80-206-0004
Analytic Jena Specord 205, Dissolution
ready
9. Tubing + Connectors
Tubing + Connectors UV-VIS Online
70-20x-0001
25
Dissolution Offline-Kits
“BUDGET” Kit
(storage/doses into tubes only)
The “BUDGET” Offline Kit with fixed stainless For more precise dosing – after collection – the
steel sample withdraw tubes to collect into x/y driven arm moves down to a selected sam-
glass tubes of 10 ml or 25 ml is designed to ple volume level and pumps back the sample
serve those customers with a limited budget above this level to the dissolution vessel (over-
and comprises of filling/levelling principle).
1.) 7 stainless steel (316), electro polished,
height adjustable sampling tubes (fix inside “BUDGET” Offline Kit, 7-channel
the medium) with external holder for filters 15-107-0000
2.) 8-channel Peristaltic pump with Verder-
prene tubing and RS 232 interface for ex-
ternal control
3.) FRL 720 7-channel “silent” Autosampler
with x/y driven arm in “corrosion reduced
design” for collection of up to 25 sampling
intervals into 10 ml glass tubes or 17 sam-
pling intervals into 25 ml glass tubes as
well as support arm to hold a rack.
4.) Tubing/Connector Kit, Teflon
5.) System pre-configuration
6.) Upgraded micro-controller for DT 820 se-
ries to control the complete Offline System Additional price for 8-channel version
15-1x8-xxxx
Not included: DT 820 dissolution tester and
collection rack (for glass tubes only) Additional price for Titanium sample with-
draw tubes, instead stainless steel
Operation principle: 15-xxx-1xxx
The stainless steel (optional Titanium) sample
withdraw tubes are fix installed inside the ves- Additional price for Titanium collection tubes
sel and can be manually height adjusted (mid- in the Autosampler, instead st.steel
way between the top of the media and the top 15-xxx-x2xx
of the rotating basket or paddle). For filtration
purposes a filter can be inserted into a filter Rack for holding 25x 8 glass tubes, 10 ml
holder positioned at the connection of sample 81-200-0003
withdraw tube and Teflon system tubing thus to
minimize influences to the hydrodynamics in- Rack for holding 17x 8 glass tubes, 25 ml
side the vessel. 81-200-0004
26
“BASE” Kit
(storage/doses into tubes only)
27
“PRECISION/lq” Kit
(storage/precision doses into tubes & HPLC vials, media replacement and HPLC vial
membrane piercing)
The “PRECISION/lq” Offline Kit represents the The connected 7-channel syringe Pump SP
standard USP/EP compliant ERWEKA Offline 725/10 sucks the media through the filter and
system with high precision dosing (± 0.1 ml), Teflon tubing to the syringe, passing a motor
standard media replacement, HLPC Vial mem- driven, mechanical 4-way switching valve with
brane piercing and optional dilution function. inert interior. Then the valves switch and the
The system comprises of: new Teflon coated, 2-part pistons push the
1.) Fully USP/EP compliant sampling station sample into the waiting glass tubes or
with automatic sample withdraw height ad- sealed/unsealed HPLC vials (membrane pierc-
justment and 7 stainless steel (316) sam- ing standard).
ple withdraw tubes
2.) 7-channel syringe pump SP 725/10 with 10 The FRL 720 Autosampler allows storage of up
ml syringes and mechanically operated to 25 (glass tubes of 10 ml-, HPLC vials of 1.5
valves or 4.0 ml capacity) or 17 (glass tubes of 25 ml
3.) FRL 720 7-channel “silent” Autosampler capacity) sampling intervals.
with x/y driven arm in “corrosion reduced
design” for collection of up to 25 sampling Optionally cooled racks for HPLC vials are
intervals into 10 ml glass tubes, sealed available. After sample collection the 316
1.2/4.0 ml HPLC vials or 17 sampling in- stainless steel tubes (optionally Titanium) of the
tervals into 25 ml glass tubes as well as Autosampler drive down into the replacement
support arm to hold a rack. media inside the acrylic glass reservoir which
4.) Tubing/Connector Kit, Teflon refills after each media replacement interval
5.) System pre-configuration automatically by two integrated 1-channel peri-
6.) Upgraded micro-controller for DT 820 se- staltic pumps. The syringes will transfer the
ries to control the complete Offline System desired volume to the test-stations to keep the
media volume within the USP/EP specified ±
Not included: DT 820 dissolution tester and 1% limits.
collection rack.
The FRL 720 in combination with the syringe
Operation principle: pump and 10/25 ml glass tubes allows auto-
The stainless steel (optional Titanium) sample mated dilution of the sample in the 1:1, 1:2, 1:5
withdraw tubes are driven into the media (ex- and 1:10 relations.
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only “PRECISION/lq” Offline Kit, 7-channel
while the sample is withdrawn – not to change 15-127-0000
the hydrodynamic inside the vessel – as de-
scribed in the USP and EP.
28
Additional price for 8-channel version
15-128-xxxx
29
“PRECISION/hq” Kit
(storage/precision doses into tubes & HPLC Vials, media replacement and HPLC
Vial membrane piercing)
The “PRECISION/hq” Offline Kit, in contrast to Optional the sample withdraw system can be
the “PRECISION/lq” Kit, due to the higher ca- equipped with electronic temperature sensors
pacity 25 ml syringes (dosing precision ± 0.25 for each vessel to archive media temperature
ml), allows withdrawing/storing higher volume of documentation for each test-station.
sample within a shorter time. E.g. when more
than 7 ml media has to be collected the The connected 7-channel syringe Pump SP
“PRECISION/lq” Kit needs to withdraw media 725/25 sucks the media through the filter and
twice while the “PRECISION/hq” Kit can with- Teflon tubing to the syringe, passing a motor
draw up to 20 ml at once. The system com- driven, mechanical 4-way switching valve with
prises of: inert interior. Then the valves switch and the
1.) Fully USP/EP compliant sampling station new Teflon coated, 2-part pistons push the
with automatic sample withdraw height ad- sample into the waiting glass tubes or
justment and 7 stainless steel (316) sam- sealed/unsealed HPLC vials (membrane pierc-
ple withdraw tubes ing standard).
2.) 7-channel syringe pump SP 725/25 with 25
ml syringes and mechanically operated The FRL 720 Autosampler allows storage of up
valves to 25 (glass tubes of 10 ml-, HPLC vials of 1.5
3.) FRL 720 7-channel “silent” Autosampler or 4.0 ml capacity) or 17 (glass tubes of 25 ml
with x/y driven arm in “corrosion reduced capacity) sampling intervals.
design” for collection of up to 25 sampling
intervals into 10 ml glass tubes, sealed Optionally cooled racks for HPLC vials are
1.2/4.0 ml HPLC vials or 17 sampling in- available.
tervals into 25 ml glass tubes as well as
support arm to hold a rack. After sample collection the 316 stainless steel
4.) Tubing/Connector Kit, Teflon tubes (optionally Titanium) of the Autosampler
5.) System pre-configuration drive down into the replacement media inside
6.) Upgraded micro-controller for DT 820 se- the acrylic glass reservoir which refills after
ries to control the complete Offline System each media replacement interval automatically
by two integrated 1-channel peristaltic pumps.
Not included: DT 820 dissolution tester and The syringes will transfer the desired volume to
collection rack. the test-stations to keep the media volume
within the USP/EP specified ± 1% limits.
Operation principle:
The stainless steel (optional Titanium) sample The FRL 720 in combination with the syringe
withdraw tubes are driven into the media (ex- pump and 10/25 ml glass tubes allows auto-
actly midway between the top of the media and mated dilution of the sample in the 1:1, 1:2, 1:5
the top of the rotating Basket or Paddle) and 1:10 relations.
only while the sample is withdrawn – not to
change the hydrodynamic inside the vessel – “PRECISION/hq” Offline Kit, 7-channel
as described in the USP and EP. 15-147-0000
30
Additional price for 8-channel version
15-148-xxxx
31
“FAST” Kit
(storage/doses into tubes & HPLC vials, media replacement and HPLC vial mem-
brane piercing)
The dosing-by-valves “FAST” Kit offers best Optional the sample withdraw system can be
possible dosing results in combination with the equipped with electronic temperature sensors
easy-to-use, budget 8-channel peristaltic pump for each vessel to archive media temperature
in combination with short sampling intervals documentation for each test-station.
(from 2 minutes).
During the sample withdraw tubes are inside
The system allows precision sample dosing into the media the peristaltic pump pumps the me-
glass tubes (10 ml/25 ml) or sealed/unsealed dia in a cycle from the vessel through the Auto-
HPLC vials (1.5 ml/4.0 ml), accurate media sampler back to the vessel until all air inside the
replacement as well as HPLC membrane pierc- tubing system is removed and the filters are
ing. The system comprises of: saturated.
1.) Fully USP/EP compliant sampling station
with automatic sample withdraw height ad- Then the 3-way solenoid valves inside the arm
justment and 7 stainless steel (316) sam- of the FRL 724 Autosampler switch and the
ple withdraw tubes required amount of media is collected in either
2.) 8-channel peristaltic pump with Verder- glass tubes (10/25 ml) or sealed/unsealed
prene tubing HPLC vials (1.5/4.0 ml) with an accuracy of ±
3.) FRL 724 7-channel “silent” Autosampler 0.5 ml.
with 7x 3-way-valves and x/y driven arm in
“corrosion reduced design” for collection of Optionally cooled racks for HPLC vials are
up to 25 sampling intervals into 10 ml glass available.
tubes, sealed 1.2/4.0 ml HPLC vials or 17
sampling intervals into 25 ml glass tubes After sample collection the 316 stainless steel
as well as support arm to hold a rack. tubes (optionally Titanium) of the Autosampler
4.) Tubing/Connector Kit, Teflon drive to and into the replacement media inside
5.) System pre-configuration the acrylic glass reservoir which refills after
6.) Upgraded micro-controller for DT 820 se- each media replacement interval automatically
ries to control the complete Offline System by two integrated 1-channel peristaltic pumps.
The 8-channel peristaltic pump will transfer the
Not included: DT 820 dissolution tester and desired volume to the test-stations (vessels) to
collection rack keep the media volume within the USP/EP
specified ± 1% limits.
Operation principle:
The stainless steel (optional Titanium) sample “FAST” Offline Kit, 7-channel
withdraw tubes are driven into the media (ex- 15-157-0000
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only
while the sample is withdrawn – not to change
the hydrodynamic inside the vessel – as de-
scribed in the USP and EP.
32
Additional price for 8-channel version
15-158-xxxx
33
“POWER” Kit
(storage/doses into tubes & HPLC vials, media replacement, HPLC vial membrane
piercing, filtration from 0.22 µm)
The dosing-by-valves “POWER” Kit represents Optional the sample withdraw system can be
the high-end ERWEKA Offline Kit which offers equipped with electronic temperature sensors
features such as membrane filtration from as for each vessel to archive media temperature
low as 0.22 µm, precision dosing (better ± 0.5 documentation for each test-station.
ml without regular pump-channel calibra-
tion/adjustment) and extremely short sampling During the sample withdraw tubes are inside
intervals (from 2 minutes). the media the piston pump pumps the media in
a cycle from the vessel through the membrane
The system collects into glass tubes (10 ml/25 filter (optional) through the Autosampler back to
ml) or sealed/unsealed HPLC vials (1.5 ml/4.0 the vessel, until all air inside the tubing system
ml) and offers accurate media replacement as is removed and the filters are saturated.
well as HPLC membrane piercing. The system
comprises of: Then the 3-way solenoid valves inside the arm
1.) Fully USP/EP compliant sampling station of the FRL 724 Autosampler switch and the
with automatic sample withdraw height ad- required amount of media is collected in either
justment and 7 stainless steel (316) sam- glass tubes (10/25 ml) or sealed/unsealed
ple withdraw tubes HPLC vials (1.5/4.0 ml) with an accuracy of
2.) 7-channel, valve-free piston pump with better ± 0.5 ml.
Teflon/Ceramic pump-heads
3.) FRL 724 7-channel “silent” Autosampler The FRL 724 Autosampler allows storage of up
with 7x 3-way-valves and x/y driven arm in to 25 (glass tubes of 10 ml-, HPLC vials of 1.5
“corrosion reduced design” for collection of or 4.0 ml capacity) or 17 (glass tubes of 25 ml
up to 25 sampling intervals into 10 ml glass capacity) sampling intervals.
tubes, sealed 1.2/4.0 ml HPLC vials or 17
sampling intervals into 25 ml glass tubes Optionally cooled racks for HPLC vials are
as well as support arm to hold a rack. available.
4.) Tubing/Connector Kit, Teflon
5.) System pre-configuration After sample collection the 316 stainless steel
6.) Upgraded micro-controller for DT 820 se- tubes (optionally Titanium) of the Autosampler
ries to control the complete Offline drive to and into the replacement media inside
the acrylic glass reservoir which refills after
Not included: DT 820 dissolution tester and each media replacement interval automatically
collection rack by two integrated 1-channel peristaltic pumps.
The piston pump will transfer the desired vol-
Operation principle: ume to the test-stations to keep the media vol-
The stainless steel (optional Titanium) sample ume within the USP/EP specified ± 1% limits.
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and “POWER” Offline Kit, 7-channel
the top of the rotating Basket or Paddle) only 15-167-0000
while the sample is withdrawn – not to change
the hydrodynamic inside the vessel – as de-
scribed in the USP and EP.
34
Additional price for 8-channel version
15-168-xxxx
35
“BASE-14” Kit
(storage/doses into tubes only)
The “BASE-14” Offline Kit represents the basic For more precise dosing – after collection – the
USP/EP compliant ERWEKA offline system for x/y driven arm moves down to a selected sam-
14 test-stations where the stainless steel (316) ple volume level and pumps back the sample
sample withdraw tubes are driven into the me- above this level to the dissolution vessel (over-
dia, to the exact USP/EP sampling height, only filling/levelling principle).
while the sample is withdrawn – not to change
the hydrodynamics constantly. “BASE-14” Offline Kit, 14-channel
The “BASE-14” version allows collecting into 16-128-0000
glass tubes of 10 ml or 25ml.
Not included: DT 1420 dissolution tester and Additional price for electronic temperature
collection rack (for glass tubes only) sensors for media temperature measure-
ment/documentation in each test-station
Operation principle: 16-xxx-xx1x
The stainless steel (optional Titanium) sample
withdraw tubes are driven into the media (ex- Rack for holding 25x 8 glass tubes, 10 ml
actly midway between the top of the media and 80-300-0003
the top of the rotating Basket or Paddle) only
while the sample is withdrawn – not to change Glass tubes, 10 ml (100 pcs.)
the hydrodynamic inside the vessel – as de- 91-200-0003
scribed in the USP and EP.
Rack for holding 17x 8 glass tubes, 25 ml
The connected pump (16-channel peristaltic 80-300-0004
pump) transfers the sample to collect from the
vessel into glass tubes (10ml or 25 ml maxi- Glass tubes, 25 ml (100 pcs.)
mum capacity) positioned in the rack at the 91-200-0004
Autosampler.
36
“FAST-14” Kit
(storage/doses into tubes & HPLC vials, media replacement and HPLC vial mem-
brane piercing)
The dosing-by-valves “FAST-14” Kit offers best During the sample withdraw tubes are inside
possible dosing results in combination with the the media the peristaltic pump pumps the me-
easy-to-use, budget 16-channel peristaltic dia in a cycle from the vessel through the Auto-
pump in combination with short sampling inter- sampler back to the vessel, until all air inside
vals (from 2 minutes). the tubing system is removed and the filters are
saturated.
The system allows precision sample dosing into
glass tubes (10 ml / 25 ml) or sealed/unsealed Then 3-way solenoid valves inside the arm of
HPLC vials (1.5 ml/4.0 ml), accurate media the FRL 724-2 Autosampler switch and the
replacement as well as HPLC membrane pierc- required amount of media is collected in either
ing. The system comprises of: glass tubes (10/25 ml) or sealed/unsealed
1.) Fully USP/EP compliant sampling station HPLC vials (1.5/4.0 ml) with an accuracy of ±
with automatic sample withdraw height ad- 0.5 ml.
justment and 14 stainless steel (316) sam-
ple withdraw tubes Optionally cooled racks for HPLC vials are
2.) 16-channel peristaltic pump with Verder- available.
prene tubing
3.) FRL 724-2 14-channel “silent” Autosampler After sample collection the 316 stainless steel
with 14x 3-way-valves and x/y driven arm tubes (optionally Titanium) of the Autosampler
in “corrosion reduced design” for collection drive to and into the replacement media inside
of up to 12 sampling intervals into 10 ml the acrylic glass reservoir which refills after
glass tubes, sealed 1.2/4.0 ml HPLC vials each media replacement interval automatically
or 8 sampling intervals into 25 ml glass by two integrated 1-channel peristaltic pumps.
tubes as well as support arm to hold a The syringes will transfer the desired volume to
rack. the test-stations to keep the media volume
4.) Tubing/Connector Kit, Teflon within the USP/EP specified ± 1% limits.
5.) System pre-configuration
6.) Upgraded DT 1420i series to control the “FAST-14” Offline Kit, 14-channel
complete Offline System, incl. alpha- 16-148-0000
numeric keypad, graphic LC display and
product memory
Operation principle:
The stainless steel (optional Titanium) sample
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and
the top of the rotating Basket or Paddle)
only while the sample is withdrawn – not to
change the hydrodynamic inside the vessel –
as described in the USP and EP.
37
Additional price for Titanium sample with-
draw tubes, instead stainless steel
16-xxx-1xxx
38
ERWEKA UV-VIS In- or Online System
(analysis only)
230V/50 Hz 72-206-2031
230V/60Hz 72-206-2032
With the standard ERWEKA 8-channel Peristal- 115V/60Hz 72-206-2033
tic Pump (IPC 8) the sample is taken from the 127V/60Hz 72-206-2034
test vessel and pumped through to the cells of
the spectrophotometer. After analysis the sam- Analytic Jena Specord 205
ple is transferred back to the test vessel. double beam including 8 position cell changer,
ready for Online Systems
Pump tubing’s are made of Verderprene (simi-
lar to Teflon) to prevent the absorption previ-
230V/50Hz 70-208-9001
ously associated with peristaltic pumps and
230V/60Hz 70-208-9002
silicone tubing.
115V/60Hz 70-208-9003
127V/60Hz 70-208-9004
Via the serial RS 232 interface the pump is
controlled from the external PC.
ERWEKA SPM
8-channel Peristaltic Pump
Double beam
RS 232 serial interface for external control
including 8 posi-
Touch sensitive keys and LC display
tion cell
Verderprene tubing for elimination of ab-
changer, ready
sorption of active ingredients by silicone
for Online Sys-
tubing
tems including
tubing.
230V/50Hz 72-203-0001
230V/60Hz 72-203-0002
115V/60Hz 72-203-0003
127V/60Hz 72-203-0004
39
Perkin Elmer 3. System Control
Lambda 25
Double beam in-
cluding 8 position
3.1. Disso.net Software
cell changer, ready
for Online System Windows based ERWEKA
including tubing Disso.net software
and Perkin Elmer WinLab V6 Software Package Disso.net. Windows based
CFR 21/11 compliant
230V/50Hz 72-203-2001 ERWEKA Dissolution Sys-
230V/60Hz 72-203-2002 tem Software Disso.net
115V/60Hz 72-203-2003
127V/60Hz 72-203-2004 Recommended PC configuration:
- Processor: Pentium IV 1.2 GHz
Optional WinLab V6 ES (CFR 21. Part 11) - Memory: 256 MB, HDD free space: 300 MB
- Operating system: MS Windows 7 or MS
230V/50Hz 71-203-2021 Windows XP Professional
230V/60Hz 71-203-2022 - Screen resolution: 1024x768 (minimal),
115V/60Hz 71-203-2023 1280x1024 (recommended)
127V/60Hz 71-203-2024
3.2. Driver for Agilent 8453 Chem
Station software
Perkin Elmer
Lambda 35 Driver for Agilent Chem Station Software to
Double beam in- connect and control dissolution testers of the
cluding 8 position ERWEKA DT 720/820 series
cell changer, ready
for Online System 4. System Tubing
including tubing
and WinLab V6 Perkin Elmer Software Pack- System Tubing, complete with tubing and con-
age. nectors, Teflon 3.0 mm o.d., configured as
230V/50Hz 72-203-2011 Inline-System (return to vessel after analysis).
230V/60Hz 72-203-2012
115V/60Hz 72-203-2013 5. System Pre-Configuration
127V/60Hz 72-203-2014
Control and Pre-Configuration of the complete
system at the ERWEKA laboratory. Control of
Agilent 8453, function and numbering of all tubes and inter-
including 8 position face cables for easy connection at the custom-
cell changer, ready for ers site.
Online Systems in-
cluding tubing
6. Computer
Brand name computer in minitower housing
- Intel Pentium Dual Core E5700 (3,0 GHz)
230V/50Hz 72-203-5001 - 2GB Memory
230V/60Hz 72-203-5002 - Festplatte 250 GB
115V/60Hz 72-203-5003 - Grafikkarte Onboard Intel GMA 3100
127V/60Hz 72-203-5004 - Displayauflösung von 1280*1080
Operating system Microsoft Windows XP / Win-
dows 7, keyboard, scroll mouse, 17“ flat-screen
TFT monitor.
40
Prices include:
1. ERWEKA Peristaltic Pump IPC 8
2. Cuvettes for UV-VIS
2. UV-VIS Spectrophotometer incl. Cell-
Changer, With Teflon tubing (0.8 mm o.d.) and screw-
3. ERWEKA Windows based 21 CFR 11 fittings. For 8-position cell changers
compliant software, type Disso.net for
control of UV-VIS of ERWEKA, Perkin
Elmer, Shimadzu, Analytic Jena and
Agilent
4. Computer, TFT monitor, colour printer
5. Teflon Tubing/Connector Kit and Pre-
Configuration
41
ERWEKA UV-VIS On-/Offline System
42
2. UV-VIS Spectrophotometers Optional WinLab V6 ES (CFR 21. Part 11)
Perkin Elmer
Lambda 25
Double beam in-
cluding 8 position
cell changer, ready
for Online System
including tubing
and Perkin Elmer WinLab V6 Software Package
230V/50Hz 72-203-2051
230V/60Hz 72-203-2052
115V/60Hz 72-203-2053
127V/60Hz 72-203-2054
43
3. Autosampler, FRL 824 4. System Control
4.1. Disso.net Software
Windows based ERWEKA
Disso.net software
Disso.net. Windows based
CFR 21/11 compliant
ERWEKA Dissolution Sys-
tem Software Disso.net
The FRL 824 was designed to meet all users’
requirements such as storage of the samples Recommended PC configuration:
and transfer of the sample with the need of only - Processor: Pentium IV 1.2 GHz
one ERWEKA 8-channel Peristaltic Pump, Type - Memory: 256 MB, HDD free space: 300 MB
IPC 8.In combination with an ERWEKA Dissolu- - Operating system: MS Windows 7 or MS
tion Tester, the ERWEKA Dissolution Software Windows XP Professional
package and the before mentioned Peristaltic - Screen resolution: 1024x768 (minimal),
Pump, the system offers storage in either glass 1280x1024 (recommended)
tubes (25x 8 of 10 or 17x 8 of 25 ml volume) or
sealed/ unsealed HPLC vials (25x 8 of 1.5 or 4.2. Driver for Agilent 8453 Chem
4.0 ml volume). Station software
Due to the 8-channel ERWEKA Peristaltic
Pump, the samples are dosed with a high accu- Driver for Agilent Chem Station Software to
racy of volume. connect and control dissolution testers of the
When the sample is taken, the withdrawn media ERWEKA DT 720/820 series
volume may be replaced with fresh media from
a media replacement container, integrated in
the FRL 824. Two 1-channel Peristaltic Pumps
5. System Tubing
refills the media replacement container auto-
matically after the media replacement process. System Tubing, complete with tubing and con-
In combination with the ERWEKA Windows nectors, Teflon 3.0 mm o.d., configured as
based Disso.net software and an UV-VIS Spec- Inline-System (return to vessel after analysis).
trophotometer with Cell-Changer, the withdrawn
sample can be either transferred directly from 6. System Pre-Configuration
the Dissolution Tester to the UV-VIS, be stored
in the tubes of the FRL 824 and later analysed Control and Pre-Configuration of the complete
or stored in tubes and automatically transferred system at the ERWEKA laboratory. Control of
to the UV-VIS for analyses using only one function and numbering of all tubes and inter-
pump! face cables for easy connection at the custom-
ers site.
Precision dosing by the ERWEKA 8-
channel Syringe Pump, IPC 8
Stores up to 8 samples for up to 25 sam- 7. Computer
pling cycles
Samples into tubes (10 or 25 ml)
Brand name computer in minitower housing
Samples into sealed or unsealed HPLC
- Intel Pentium Dual Core E5700 (3,0 GHz)
Vials (1.5 or 4.0 ml max. volume)
- 2GB Memory
Standard HPLC Vial membrane piercing
- Festplatte 250 GB
Media replacement to stay within the
- Grafikkarte Onboard Intel GMA 3100
USP/EP specified media volume tolerance
- Displayauflösung von 1280*1080
Integrated container for replacement me-
Operating system Microsoft Windows XP / Win-
dia, incl. two 1-channel Peristaltic Pumps
dows 7, keyboard, scroll mouse, 17“ flat-screen
to refill the integrated container from an ex-
TFT monitor.
ternal one after each replacement process
Automated transfer of the sample to an
Customer specified computer, printer and moni-
UV-VIS Spectrophotometer with Cell-
tor available on special request!!!
Changer, using the ERWEKA Windows
based Disso.net software
44
ERWEKA UV-VIS Dual Online Systems
(analysis for 2 dissolution testers)
3. System Control
ERWEKA Dissolution Software type
With the standard ERWEKA 8-channel Peristal-
Disso.net
tic Pump (IPC 8) the sample is taken from the
The ERWEKA Disso.net Software is able to run
test vessel and injected to the flow-through cells
under Windows XP and Windows 7. For Dual
of the spectral photometer. After analysis the
Online System (Dissolution Testers, Sample
sample is transferred back to the test vessel.
Transfer Pumps and UV-VIS Photometer Perkin
Pump tubing’s are made of Verderprene (simi- Elmer).
lar to Teflon) to prevent the absorption previ-
ously associated with peristaltic pumps and
silicone tubing. 4. System Tubing
Via the serial RS 232 interface the pump is
controlled from the external PC. System Tubing, complete with tubing and con-
nectors, Teflon 3.0 mm o.d.
8-channel Peristaltic Pump
RS 232 serial interface for external control
Touch sensitive keys and LC display
Verderprene tubing for elimination of ab- 5. System Pre-Configuration
sorption of active ingredients by silicone
tubing Control and pre-configuration of the complete
system at the ERWEKA laboratory. Control of
function and numbering of all tubes and inter-
face cables for easy connection at the custom-
ers site.
45
6. Computer Options
Brand name computer in minitower housing 1. Cuvettes for UV-VIS (other
- Intel Pentium Dual Core E5700 (3,0 GHz)
- 2GB Memory than standard)
- Festplatte 250 GB 8 off Path Length 10 mm 80-203-2110
- Grafikkarte Onboard Intel GMA 3100 8 off Path Length 5 mm 80-203-2105
- Displayauflösung von 1280*1080 8 off Path Length 2 mm 80-203-2102
Operating system Microsoft Windows XP / Win- 8 off Path Length 1 mm 80-203-2101
dows 7, keyboard, scroll mouse, 17“ flat-screen
TFT monitor.
46
ERWEKA Half-Automated UV-VIS- and
HPLC-Online Dissolution System “HADs”
47
sample itself or by system errors such as com- Titanium Sampling- and Replacement
ing, sticking etc. So what to do with the incor- tubes (instead of st.steel), corrosion-free
rect results? To through them and hide them 80-090-0200
from the authorities? To eliminate that problem
completely the ERWEKA HADs is available with Cleaning Reservoir for sampling station;
video monitoring of six dissolution vessels of with 3 compartments to avoid any cross-
one or both connected dissolution testers. The contamination. 80-089-0000
video monitoring allows recording of each test-
run in combination with real-time overlapping
dissolution profile to identify disturbances such 2. Video Monitoring/Recording
as coning etc. and to get the visual impression
of 24 hours in 2 minutes. The video monitoring Video Monitoring/Recording of Dissolution
is a very powerful tool for method development Tester 1 (6 stations). Recording of the disso-
as well for troubleshooting. lution process and time laps view with real-
time dissolution curve overlay (overlay only
230V/50Hz 72-210-0001 in combination with UV-VIS Online analysis)
230V/60Hz 72-210-0002 72-210-1xxx
115V/60Hz 72-210-0003
127V/60Hz 71-210-0004 Video Monitoring/Recording of Dissolution
Tester 2 (6 stations).Recording of the disso-
lution process and time laps view with real-
1. Dissolution Tester/s time dissolution curve overlay (overlay only
up to two Dissolution Testers can be con- in combination with UV-VIS Online analysis)
nected to one HADs 72-210-2xxx
48
4. Sample Transfer Pump Rack (93+5), cooled
Offline sample collection (cooled; 4°C -
Sample Transfer Pump, Peristaltic 8-channel 70°C) into sealed HPLC vials (93 for collec-
Ismatec Peristaltic Pump incl. Verderprene tion + 5 for standards), for automatic transfer
tubing. Usage depends (usually not below to the 6-port HPLC valve 72-21x-x3xx
1µm) on filter and product to be used.
11-202-5000 Rack (319+5), cooled
Offline sample collection (cooled; 4°C -
Sample Transfer Pump, Piston (high pres- 70°C) into sealed HPLC vials (319 for collec-
sure) 8-channel ERWEKA valve-free Tef- tion + 5 for standards), for automatic transfer
lon/Ceramics Piston Pump. Dependant on to the 6-port HPLC valve 72-21x-x4xx
the product this pump allows filtration down
to 0.22µm due to the high pressure created. Software Package Disso.net
High dosage accuracy. 10-312-1201 Software for control of Dissolution Tester/s,
Automatic Filter Changer/s, Sample Transfer
Pump/s and HADs 14-950-3005
5. Half-automated HPLC- and UV-VIS integration Module
UV-VIS Online, HADs Integration of UV-VIS Spectrophotometer in-
to the flow-line of the Dissolution Tester; incl.
HADs Base Module UV-VIS Spectrophotometer (ERWEKA SPM,
HADs for HPLC Online analysis, incl. block Perkin Elmer Lambda 25 or Shimadzu 1800)
of sealed PEEK flow-through vials, rack for with 8 position cell changer, Dissolution Kit,
up to 5 standards for calibration and system additional tubing/connectors and upgraded
suitability, needle/syringe wash-station, me- validated Disso.Net dissolution software for
dia replacement, sample handling system, 1- Online UV-VIS analysis incl. protocols. Ex-
channel syringe pump, 6-port HPLC valve cluding flow-through cuvettes! 72-21x-xx10
and system tubing/pre configuration; for
connection of 1 Dissolution Tester; for con- UV-VIS integration Module, Agilent
nection of 1 HPLC system with software Integration of UV-VIS Spectrophotometer in-
(Agilent, Waters, Shimadzu, Merck/Hitachi to the flow-line of the Dissolution Tester; incl.
etc.) Price excluding sample transfer pump, UV-VIS DAD Photometer (Agilent 8453) with
sample collection rack, software and HPLC- 8 position cell changer, Dissolution Kit, addi-
and UV-VIS unit! 72-210-0001-4 tional tubing/connectors and upgraded vali-
dated Disso.Net dissolution software for On-
Dual System Upgrade line UV-VIS analysis incl. protocols. Exclud-
Possibility of connecting a 2nd Dissolution ing flow-through cuvettes!
Tester to HADs; incl. 2nd block of sealed 72-21x-xx2x
PEEK flow-through vials, system tub-
ing/configuration and software upgrade.2nd Flow-Through optimized Cuvette, 20 mm
Dissolution Tester and Sample Transfer (only for Agilent 8453) 80-203-0020
Pump required! 72-211-xxxx
Flow-Through optimized Cuvette, 10 mm
TTL Interface box for TTL-controlled HPLC 80-203-0010
connections, e.g. Agilent 81-010-0001
Flow-Through optimized Cuvette, 5 mm
Rack (103+5) 80-203-0005
Offline sample collection into sealed HPLC
vials (103 for collection + 5 for standards), Flow-Through optimized Cuvette, 2 mm
for automatic transfer to the 6-port HPLC 80-203-0002
valve 72-21x-x1xx
Flow-Through optimized Cuvette, 1 mm
Rack (319+5) 80-203-0001
Offline sample collection into sealed HPLC
vials (319 for collection + 5 for standards),
for automatic transfer to the 6-port HPLC
valve 72-21x-x2xx
49
PC
PC supplied by the customer according to
ERWEKA specification; delivered to
ERWEKA; installation of Disso.net
62-210-1000
Installation Services
Installation and IQ/OQ/PVT on-site exclud-
ing travel expenses 62-210-0000
50
Dissolution Accessories Glass, 2000 ml
80-000-2012
Glassware for Dissolution USP round-bottomed vessel with pedestal,
made of glass, numbered, 2000 ml
Polycarbonate, 1000 ml
85-000-2012
80-000-1001 USP round-bottomed vessel with pedestal,
USP round-bottomed ves- made of glass, numbered with certificate of
sel, made of plastics, compliance, 2000 ml
1000 ml
80-000-2014
UV-resistant USP round-bottomed vessel with
pedestal, made of glass, 2000 ml
85-000-2014
Glass, 1000 ml UV-resistant USP round-bottomed vessel with
pedestal, made of glass, numbered with certifi-
80-000-0012 cate of compliance, 2000 ml
USP round-bottomed vessel
with pedestal, made of
glass, numbered, 1000 ml As of 2010 1000 and 2000 ml vessels will be
delivered with integrated stand. The stand is
®
85-000-0012 made of Polyoxymethylene-Delrin and can be
USP round-bottomed ves- removed - if necessary.
sel, made of glass with ped-
estal, numbered and with Glass, 250 ml
certificate of compliance,
1000 ml 80-000-0202
Round-bottomed vessel,
made of glass, 250 ml
80-000-2014
UV-resistant USP round- 80-000-0204
bottomed vessel with pedes- Round-bottomed vessel,
tal, made of glass, 1000 ml glass, 250 ml
85-000-0014
UV-resistant USP round- Conversion Kit for 250 ml Vessels
bottomed vessel with pedes-
tal, made of glass, num- 84-000-9200
bered and with certificate of Conversion Kit for
compliance, 1000 ml holding Mini-Vessel
(1) in standard Vessel
opening; comprising
of adapter ring and
cover (without Mini-
Vessel); for High-
Head use
81-000-7213
Conversion Kit HH
51
Stirring Elements
89-020-6001 Basket holder (st. steel) with
USP apparatus 1 (Basket) upper shaft (integrated in drive
head) and lower shaft (Teflon)
UniShaft - basket holders and shafts for 1000 ml vessel – with O-ring
and spring, numbered with cer-
84-010-6012 Basket holder (st. steel) with tificate of compliance; for High-
upper shaft (integrated in drive Head use
head) and lower shaft (st. steel)
for 1000 ml vessel – with O-ring 84-030-6011 Basket holder (st. steel) with
and spring, numbered; for Low- upper shaft (integrated in drive
Head use head) and lower shaft (Teflon)
for 2000 ml vessel – with O-ring
84-010-6011 Basket holder (st. steel) with and spring, numbered; for High-
upper shaft (integrated in drive Head use
head) and lower shaft (Teflon)
for 1000 ml vessel – with O-ring 89-030-6001 Basket holder (st. steel) with
and spring, numbered; for Low- upper shaft (integrated in drive
Head use head) and lower shaft (Teflon)
for 1000 ml vessel – with O-ring
89-010-6001 Basket holder (st. steel) with and spring, numbered with cer-
upper shaft (integrated in drive tificate of compliance; for High-
head) and lower shaft (Teflon) Head use
for 1000 ml vessel – with O-ring
and spring, numbered with cer- 84-000-6012 Reduced price (elimination of
tificate of compliance; for Low- upper shaft) when ordering in
Head use addition to Paddles)
52
Baskets 89-010-7002 Upper shaft (integrated in drive
head) and lower shaft with Pad-
90-000-6040 dle (st. steel), for 1000 ml vessel,
USP Basket mesh 40, num- numbered with certificate of
bered compliance; for Low-Head use
53
Apparatus 5 81-000-9011
USP st.steel Rotating Cylinder, long version, to
(Paddle over Disc) screw to Shaft; for High-Head use
81-000-9010
USP st.steel Rotating
Cylinder, long version, to
screw to Shaft; for Low-
Head use
86-000-9010
USP st.steel Rotating
Cylinder, long version,
numbered with certificate of conformity, to
screw to Shaft; for Low-Head use
81-000-9001
USP st.steel Rotating Cylinder, short version, to
screw to Shaft; for High-Head use
86-000-9001
USP st.steel Rotating Cylinder, short version,
numbered with certificate of conformity, to
screw to Shaft; for High-Head use
54
Felodipine Bas ket (Stationary Dissolution Consumables
Basket) UniShaft
Filters for manual and automated
Comprising of 1x Felodipine sampling
Basket with Holder and 1x
V-shaped Vessel-Cover with To connect to automatic sampling station of DT
thread to screw Felodipine 90, DT 80, DT 70, DT 700, DT 800, DT 620, DT
Basket; for Low-Head use 720 and DT 820 DT 1420 as well as for fixed
84-000-4100 for 1000 ml sampling tubes and manual sampling manifold.
High Head use, comprising
of 1x Felodipine Basket with 70-000-2025 Set (25) of Filters, Poroplast,
Holder and 1x Vessel Cover with thread to 1µm
screw Felodipine Basket 70-000-2100 Set (100) of Filters, Poroplast,
84-100-4100 1µm
70-000-2999 Set (1000) of Filters, Poroplast,
1µm
84-060-4100 V-shaped Low-Head Vessel– 70-000-3025 Set (25) of Filters, Poroplast,
Cover, plastic, for fixing 4µm
Felodipine Basket; additional 70-000-3100 Set (100) of Filters, Poroplast,
delivery 4µm
70-000-3999 Set (1000) of Filters, Poroplast,
84-061-4100 V-shaped Low-Head Vessel– 4µm
Cover, Teflon, for fixing
Felodipine Basket; additional 70-000-4025
delivery Set (25) of Filters,
Poroplast, 10µm
84-100-4100 Felodipine Basket (stationary
Basket) for High-Head use 70-000-4100
Set (100) of Filters,
84-160-4100 Low-Evaporation High-Head Poroplast, 10µm
Vessel-Cover for fixing Felodip-
ine Basket 70-000-4999
Set (1000) of Filters,
Intrinsic Dissolution Poroplast, 10µm
(Wood Apparatus) UniShaft
70-000-5025 Set (25) of Filters, Poroplast,
ERWEKA Wood 20µm
Apparatus with 10 70-000-5100 Set (100) of Filters, Poroplast,
mm² surface area. 20µm
The tool includes 70-000-5999 Set (1000) of Filters, Poroplast,
hardened punch, 20µm
controlled surface
area and improved 70-000-6002
die design. Pre-Filters, st. steel,
20µm
Complete set including holder, punch, die,
intrinsic die and surface plate; for Low- 70-000-6005
Head use 80-000-9900 Pre-Filters, st. steel,
50µm
Complete set including holder, punch, die,
intrinsic die and surface plate; for High- 70-000-6001
Head use 80-100-9900 Pre-Filters, st. steel, 100µm
55
Membrane Filters for Double Filtra- 84-096-0002
tion System and AFC 825 Filter Additional st. steel sampling tube with marks
and holder for High-Head Basket use.
Changer
84-096-0012
82-085-0101 1 Pack (200) of Filters, Mem- Ditto., but Titanium sampling tube
brane 1µm ROBY
82-085-0102 1 Pack (200) of Filters, Mem- 14-096-0006
brane 0,7µm ROBY Syringe connected to stainless steel sampling
82-085-0103 1 Pack (200) of Filters, Mem- probe; for High- and Low-Head use
brane 0,45µm ROBY
10-096-0003
Eppendorf Sampling
Manual sampling manifold Pipette for Low-Head
Dissolution Testers.
10-096-0006 One-hand operation
Manual sampling manifolds
(basic) for ERWEKA Low–
Head use. Comprising of sy-
ringe and st. steel sampling Sinkers
tube; 6x
70-000-5000
“Japanese” Type
14-096-0001 of sinker, st.steel
For Low-Head Paddle use. 316, not magnetic,
Consisting of a syringe, LUER set of 6
connector, st. steel sampling
tube with height adjustment
marks and adjustable holder
for USP/EP/JP compliant
sample withdraw (midway 70-000-5001
between top for paddle and “Spider” Type of sinker, plas-
surface of media) tics, set of 6
14-096-0011
Ditto., but with Titanium sampling tube
84-096-0001
Additional st.steel sampling tube with marks
and holder for Low-Head Basket use.
80-096-0011
Ditto., but Titanium sampling tube
14-096-0002
For High-Head Paddle use.
Consisting of a syringe, LUER
connector, st. steel sampling
tube with height adjustment
marks and adjustable holder
for USP/EP/ JP compliant
sample with-
draw (midway between top for basket and sur-
face of media)
14-096-0012
Ditto., but with Titanium sampling tube
56
IQ/OQ/PVT documents for Dis- Qualification Tool Kit for Mechanical Qualifica-
tion according to FDA (USP method 1 and 2,
solution Testers and Dissolu- certified) for UniShaft
tion Systems
Includes:
63-000-9999 IQ/OQ/PVT documents for - Guidance adapter
ERWEKA DT 620/720/820 se- - Digital level with
ries / Mechanical Calibration measurement
according FDA adapter
- Clamp for meter
63-012-9999 IQ/OQ/PVT documents for (measurement of
ERWEKA DT 1420 series / Me- the wobble)
chanical Calibration according - Clamp for digital tachometer (measurement
FDA of the agitation speed)
- Angular probe
65-098-9999 IQ/OQ/PVT documents for - Digital gauge
ERWEKA Flow-Through-Cell - Measuring tips, extensions of meter, meas-
Dissolution Tester, Type DFZ urement plate
720/T - Qualified UniShaft including actuator
- Tool for stirring height
75-203-x999 IQ/OQ/PVT document for Off-/ - Gap gauge
Online System / Mechanical - Digital tachometer
Calibration according FDA - Reflection strip for tachometer
- Digital pocket thermometer
- Disk
- Hexagon wrench
USP Reference Tablets and 69-002-1021
Standards (PVT)
Qualification Tool Kit for Mechanical Qualifica-
tion – Upgrade Kit without digital thermometer
66-001-0001 and electronic RPM measurement unit for Un-
1 bottle (30) of USP iShaft 69-002-1031
Reference Tablets,
95-001-0006
Prednisone
Digital Spirit Level for Horizontal measurement
according FDA (including all adapters), certified
66-001-0003
250 mg of standard for 95-001-0008
Prednisone Toolset for Vessel verticality and Shaft centricity
according FDA / UniShaft (including Shaft, cen-
tring tool, gauge and adapter), certified
69-001-0011
Standard Qualification (certified) acc. USP/EP
Includes:
- Electronic RPM meas-
uring unit
- Horizontal measure-
ment tool
- Wobble and centricity
measuring unit
- Qualification tool for
height of method
- Digital Thermometer
57
80-124-0003
Holder for former ERWEKA dissolution tester,
DT 70 / 80, DT 6 to handle wobble measure-
ment device, tachometer and spirit-level
99-001-0001
Electronic RPM meas-
urement unit, contact
less; including reflector
marks (35)
90-001-0003
Spare Reflector Marks (35) for speed
70-001-0001
Horizontality measure-
ment tool
75-001-0003
Immersion
thermometer with
certificate
85-001-0003
Digital thermometer
with certificate
99-001-0002
Wobble and Cen-
tricity measure-
ment unit, certi-
fied
95-001-0005
Qualification tool for
height adjustment of
Basket, and Rotating
Cylinder, numbered
with certificate of con-
formity
58
Dissolution Tester (USP apparatus 3 and 7)
CALEVA BioDis
Dissolution Tester with 6, 7 or 8 rows
RRT 10 (for USP 3 use), with 6 rows, each 6
test positions + 2 reference position
230V/50Hz 72-226-0001
230V/60Hz 72-226-0002
115V/60Hz 72-226-0003
127V/60Hz 72-226-0004
59
USP 7 Options Qualification
1000 ml conversion kit IQ/OQ/PVT Document 66-121-9999
Comprising of 4x 3 1000 ml vessel, 12x
adaptor for rack, 12x evaporation cover and IQ/OQ/PVT tool kit, certified (includes: Digi-
12 adaptors for vessel 82-226-1007 tal Tachometer, Calibrated Thermometer,
Steel Ruler, Stopwatch)
100 ml conversion kit 65-121-0000
Comprising of 48x 100 ml vessel, 48x adap-
tor for rack, 48x evaporation cover and 48 Bottle (60) Chlorpheniramine Maleate Tab-
adaptors for vessel 82-226-0107 lets 85-120-0000
60
Dissolution Tester (USP apparatus 4)
ERWEKA DFZ 720 ERWEKA USP apparatus 4
Flow-Through-Cell with 7 stations Pump, HKP 720
according to USP apparatus 4
The ERWEKA DFZ Dissolution Testers offer The valve-free ERWEKA Piston Pump HKP 720
the typical advantages of USP apparatus 4 but is specially designed for the use with USP ap-
eliminate the typical disadvantages. paratus 4 Flow-Through-Cell. In standard con-
ERWEKA designed a new valve-free pump with figuration it offers a flow rate from 2.0 ml to 32.0
automatic deaeration and volume adjustment. ml at 120 strokes/minute and an accuracy of
5%. Unlike other USP 4 pumps the HKP 720
DHC 2000i – flow heater with 2 temp. sen- offers automated deaeration at the start of the
sors, 1x internal and 1x external for the operation.
water bath The required flow rate is just pre-set by the
Water distribution system integrated menu and the HKP 720 will adjust
One three-way valve for control of the wa- the requested flow rate by itself.
ter flow There are no valves incorporated in the HKP
Plastic support plate for the cells 720 to eliminate the problems of particles stick-
Deep drawn tray water bath + metal hous- ing.
ing incl. view window
Immersion thermometer for control of the 7-channels
temperature in the water bath Valve-free design
“Quick-Screw” closing system for the cells Automatic de-airing of the pump heads
Teflon tubing 1.6 mm or 3.0 mm o.d. Pump heads made of Teflon and ceramics
High Accuracy (5 %)
7 Cell type with immersion thermometer to Automatic flow rate adjustment
control the temperature in the water bath Parallel printer interface for documentation
of strokes/min.
7 cell type, Serial RS 232 interface for external control
excluding cells Teflon tubing
61
Options
Peristaltic Pump for Low-Flow Filters for Flow-Through-Cell
Filter for USP 4; 0.7 µm; 25 pcs; 15 mm
(for Granulate & Powder Cells, Implant
Cells, Stent Cells) 70-212-1507
11-202-5001
Electronic switching valve for up to 4 media
changes (only in combination with System Con-
Media Transfer Station, Type LMT, to create trol Unit, type SE) 80-012-0003
a “Close-Loop” system
Thermostatically heated water bath with 6x Online Deaeration Device (only in the pH range
1000 ml beaker glasses, stand with mag- of 4 to 6.5) 80-012-0004
netic stirrer for each beaker glass, Teflon
tubing 80-012-1000
62
80-012-0007 Media temperature measurement in each
Set (7) of USP 12.0 mm cell by integrated electronic PT 100 tem-
Cells perature sensors (temperature displayed
and printed by Control Unit, Type SE)
10-013-xxxx
80-012-3007
Set (7) of USP Granulate
& Powder Cells
80-012-5007
Set (7) of USP Granulate
& Powder Cells accord-
ing to EP
80-012-4007
Set (7) of USP Implant
Cells
80-012-7007
Set (7) of USP Stent
Cells
80-012-6007
Set (7) of USP Cream
Cells Adapter
63
Dissolution Systems
ERWEKA Dissolution System Open - Loop Offline Kit
(storage and control only)
230V/50Hz 71-020-0001
230V/60Hz 71-020-0002
115V/60Hz 71-020-0003
127V/60Hz 71-020-0004
64
Options
1. Racks
Rack for 25x 8 HPLC vials of 4.0 ml vol-
ume 81-200-0003
2. ph change valve
Manual switching valve
for pH media change
80-012-0000
65
ERWEKA Dissolution System Closed - Loop Offline Kit
(to complete the DFZ Closed Loop system required one; HKP, LMT, DFZ)
66
6. Media Transfer Station LMT
Media Transfer Station, Type LMT, to create
a “Close- Loop” system.
Thermostatically heated water bath with 6x
1000 ml beaker glass, stand with magnetic
stirrer for each beaker glass, Teflon tubing
80-012-1000
230V/50Hz 71-020-00x1
230V/60Hz 71-020-00x2
115V/60Hz 71-020-00x3
127V/60Hz 71-020-00x4
Options
1. Autosampler
Additional price for media replacement, incl.
two integrated 1-channel peristaltic pumps
and a two-section acrylic glass container
15-xx8-xxx1
2. Racks
Rack for 25x 8 HPLC vials of 4.0 ml Volume
80-200-0002
67
Dissolution Media Preparation and Dosing
ERWEKA MediPrep 120 Media Tank
ERWEKA Media Pre-
Heating Tank MT66,
MT120, and MT160 (for
connection to MediPrep
120). For your media
storage ERWEKA of-
fers tanks made of
Polyethilen or st.steel
(66 l, 120 l, or 160 l
volume –
other sizes on request.) The tanks pre-heat the
media and can be moved around the laboratory
on 3” diameter casters. Media is heated by
means of the integrated 1.500 Watts (at 230V)
electronic flow through heater (therefore no
stirring is required). Temperature is adjustable
between 10°C and 50°C, temperature display.
Options
Dissolved oxygen meter 80-099-6200
230V/50Hz 70-099-6001
230V/60Hz 70-099-6002
115V/60Hz 70-099-6003
127V/60Hz 70-099-6004
68
ERWEKA MultiPrep
Technical Data
Display/Keypad: 4-line LCD/ Numeric touch pad
with additional function keys Printer/Interface:
parallel Memory: 60 methods/ 11 users Con-
tainer volume: 18 litre Media types: almost all,
including HCI solutions Dispencing volumes:
500ml, 750ml, 900ml, 1000ml
Dispencing accuracy: +/-1%
Temperature range: 30°C – 50°C
Temperature accuracy: +/- 0,5°C
Vacuum: max. 800 mbar
Dosing: volumetric
Mixing: gravimetric
The new degasser from ERWEKA offers pre- Preparing time for 8 x 1000ml Vessels: approx.
heating, degassing and dosing of dissolution 5min
media according to recommendations and regu- Dimensions: W413mm x D990mm x H720mm
lations of USP, EP, FDA, GLP/GMP. Weight: Net 85kg
The fully automated MultiPrep cleans itself
automatically and it is a compact unit which can
be easily connected to other dissolution devices
via the ERWEKA Disso.Net software or can run
as standalone. The easy to use menus are
Options
designed to guide users through every process.
The process can be monitored via the LCD IQ/OQ/PQ Documents
display and the numeric touch sensitive keypad 65-099-9998
with additional function keys.
Spare Part kit, including water filter, fuses
Automatic mixing of media using de-ionised and hose nozzle 91-099-0001
water and a mix of up to 6 concentrates
Usage of up to 2 pre-mixed media Printer for documentation 80-120-0009
Degassing of the applicable media allows a
minimum oxygen, leading to reliable test re- Security valve with cable and plug connec-
sults tor to avoid damage caused by turned on
Preparation and storage of up to 18 litres of water tap 70-012-0003
media at a constant temperature of 37°C
8 separate pumps and tubings support the Transformator to convert voltage (from
simultaneous filling of up to 8 vessels at the 110V into 230V) 80-099-6010
same time, ensuring identical process condi-
tions
Thanks to internal memory up to 60 methods
and up to 11 user profiles can be saved,
making the process more transparent
Load cell locking enables transportation
without damaging the balance
Fully automatic flush (cleaning) routine using
water and washing liquid. Programmed to
clean container and tubings before and after
every test preventing possible damage from
aggressive acids.
Completely menu guided calibration. Easy
Qualification due to built-in balance.
Qualification kit incl. weight 500g, weight
1kg, carrying case, screwdriver, tube and fil-
ter
230V/50Hz 70-099-7001
69
Upper jaw: Revolving according to the re-
Chewing Gum Tester DRT volving device, no up and down move-
ments
- Mounted on a heat insulated holder
- Can be easily removed for cleaning or
changing (recommended after each test)
- Distance of upper and lower jaw in closed
position adjustable between 0-10 mm
- Acid proofed stainless steel with blasted
surface for a better grip
Lower jaw: Lifting according to the device
for up and down movements
- No sliding of the sample during mastication
due to the design of the jaw and due to
separate nets between the jaws
- Metal in contact with lower jaw tempered
by the circulated water
- Acid proofed stainless steel with blasted
surface for a better grip
- Can be easily removed for cleaning or
changing. We recommend cleaning or
changing the jaw after each test run
Device for movements: Vertical pneumatic
cylinder, compressed air 6-8 bar, com-
pressed air supplied by the customer*
Test equipment to masticate chewing gums, - Movement frequency adjustable between
especially medicated ones for the in vitro re- 20 - 60 cycles per minute
lease of substances from the samples into a Temperature controlled water bath can be
surrounding liquid medium. regulated between 25 – 45 °C.
- One water bath for up to 6 test cells, vol-
Up and down strokes (vertical) of the lower jaw
ume 25 litres, made of PMMA acrylic
in combination with a revolving movement of
glass.
the upper jaw which provides mastication of the
- Electronic pump for continuous circulation
chewing gum and at the same time an agitation
of the heated water.
of the test medium.
Mobile carrier for easy transport of the
For manual sampling, emptying and cleaning whole equipment. Two level carrier with
process the lower jaw with the test cell can be rubber wheels. Made of aluminium
lowered into the down position and the chewing Electronic control of each test cell individu-
process stops. The test cell, the upper and ally
lower jaw can be easily removed. Control of movement frequencies, opera-
tion time, temperature and warming up pe-
The temperature of the water in the test cell
riod, no product memory, parallel and se-
around the media will be controlled by a water
rial interface available currently
circulation system.
Power 230 VAC, 50/60Hz, 1000 VA (W)
1 (DRT 1) or 6 test stations (DRT 6)
Revolving device for upper jaw:
- Pneumatic drive unit, compressed air 6-8 Special models with logging of pressure,
bar, compressed air to be supplied by cus- torque, pH and temperature are available.
tomer Customized models equipped for extra hard
- The angle of the revolving movement can gums or with extended volume for sparingly
be adjusted between 10° – 180° soluble substances etc are available on re-
Test Cell: Double-walled and made of quest.
glass which allows visual inspection during
the test .
- Volume for dissolution medium 20-70 ml
- Temperature controlled by a water circula-
tion system
- In- and outlet nozzle for the water circula-
tion system, Test Cell can be easily re-
moved for cleaning or changing.
70
DRT 1 with 1 test station Options for DRT
230V/50Hz 12-091-0001
230V/60Hz 12-091-0002 1000 pcs. Nets, extra 82-090-0003
115V/60Hz 12-091-0003
127V/60Hz 12-091-0004 100 pcs. 50 upper and 50 lower test jaws
82-090-0001
DRT 2 with 2 test stations
Cuvette, extra 82-090-0010
230V/50Hz 12-092-0001
230V/60Hz 12-092-0002 Cuvette, straight 82-090-0110
115V/60Hz 12-092-0003
127V/60Hz 12-092-0004 Compressor Type Fini
DRT 3 with 3 test stations 230V/50Hz 82-090-0011
230V/50Hz 12-093-0001 230V/60Hz 82-090-0012
230V/60Hz 12-093-0002 115V/60Hz 82-090-0013
115V/60Hz 12-093-0003 127V/60Hz 82-090-0014
127V/60Hz 12-093-0004 Compressor, Type Jun-Air, 32 l.
DRT 4 with 4 test stations 230V/50Hz 82-090-0021
230V/60Hz 82-090-0022
230V/50Hz 12-094-0001 115V/60Hz 82-090-0023
230V/60Hz 12-094-0002 127V/60Hz 82-090-0024
115V/60Hz 12-094-0003
127V/60Hz 12-094-0004
Compressor, Type Jun-Air, 64 l.
DRT 5 with 5 test stations 230V/50Hz 82-090-0031
230V/50Hz 12-095-0001 230V/60Hz 82-090-0032
230V/60Hz 12-095-0002 115V/60Hz 82-090-0033
115V/60Hz 12-095-0003 127V/60Hz 82-090-0034
127V/60Hz 12-095-0004
Blasting cleaning qualification (each pair)
82-090-0002
DRT 6 with 6 test stations
Spare Part Kit consists of extra cuvette and
230V/50Hz 12-096-0001 o-rings, a pair of blank upper jaws and tools.
230V/60Hz 12-096-0002 91-090-0000
115V/60Hz 12-096-0003
127V/60Hz 12-096-0004 IQ/OQ document 66-090-9999
71
Automatic Blasting Station Semi-Automatic Cleaning
Measures: approx
Station
0.6 x 0.8 m, height
0.6 m. Measures:
Cylindric drum with a di-
Demands on sup- ameter of approx 0.6 m,
ply: height 0,3 m. A crank
compressed air 6- and gearbox is con-
8 bar, 100 li- nected to the side of the
tres/min at 6 bar, drum.
compressor, res-
ervoir of 50-100 li-
tres.
Power supply 100-240 VAC, 50/60 Hz, less Demands on supply:
than 1 A. Blaster sand: Aluminium dioxide 0.2 – The cleaning station is for manual operation in
0.4 mm, 1.5 kg per batch of 18 pair of jaws. a ventilated hood or cupboard (basket funnel).
Acetone: 2 litres water free Acetone from a
The Automatic Blasting Station needs a venti- normal freezer is used at - 20 °C for each batch
lating hood or exhaust for dust that is formed of 18 pair of jaws. The Acetone may be reused
during the blasting procedure. Small amounts of many times.
blaster sand may fall on the floor during the
filling procedure. The station should not be
placed in the analytical lab. An ultrasonic water
bath is needed for final
Instruments for thickness measurements and cleaning with deionised
surface roughness are needed to control the water and Acetone (Pro
jaws and to qualify them before use. Analysi) after the blast-
ing procedure.
230V/50Hz 72-090-0001 72-091-0001
230V/60Hz 72-090-0002
115V/60Hz 72-090-0003
127V/60Hz 72-090-0004
72
Disintegration Testers
ERWEKA ZT 220 Series
1 to 4 test racks
30 ± 1 strokes/min.
55 ± 2 mm stroke height
Function keys and 2x LE display for enter-
ing nominal bath temperature and required
run-time
Starts/stops to count run-time automati-
cally when basket rack is lowered
Optional acoustic alarm on the completion
of the pre-set run-time
Manual lift-in and -out of the Baskets
73
Options
Basket Cleaning and Media Preheat Station
(ZT 221/223 only) 12-25x-x1xx
Special Versions
Disintegration Tester for testing the disintegra-
tion time of detergents. 70 ± 1 strokes/min.
Delivery without disintegration baskets
12-251-1xxx
74
ERWEKA ZT 320 Series
1 to 4 test racks
30 ± 1 strokes/min.
55 ± 2 mm stroke height
LE display/s to show remaining run-time
and actual bath temperature
Optional automatic lift-in and -out of the
Basket Racks
Integrated flow-through heating system
(accuracy ± 0.2°C)
RS 232 interface
Automatic Lift-In and Out for ZT 321 Automatic Lift-In and Out for ZT 323
12-231-1xxx 12-233-1xxx
2 Test Stations, Type ZT 322
230V/50Hz 12-232-0001
4 Test Stations, Type ZT 324
230V/60Hz 12-232-0002 230V/50Hz 12-234-0001
115V/60Hz 12-232-0003 230V/60Hz 12-234-0002
127V/60Hz 12-232-0004 115V/60Hz 12-234-0003
127V/60Hz 12-234-0004
Automatic Lift-In and Out for ZT 322
12-232-1xxx Automatic Lift-In and Out for ZT 324
12-234-1xxx
75
Options Upgrade
Automated lift-In and -out of the Basket 84-231-1001 mBasket Upgrade kit "A" (1x
Rack Assembly/-ies on start/completion of mBasket type "A", ConBox,
the pre-set run time of each test station. This ZT.net), for 1st test station
option guarantees that the disintegration of
the samples cannot go on when the pre-set 84-231-2001 mBasket Upgrade kit "B" (1x
run time is completed mBasket type "B", ConBox,
ZT.net), for 1st test station
Quick-Clean-Basket (100%
USP/EP/JP compliant) for 84-231-1002 mBasket Upgrade kit, "A" (1x
fast cleaning of the test sta- mBasket type "A"), from 2nd test
tions. No tools required for station
disassembly and assembly.
82-231-0006 84-231-2002 mBasket Upgrade kit, "B" (1x
mBasket type "B"), from 2nd test
station
Basket cleaning and media preheat station
(ZT 321/323 only) 12-23x-x1xx 84-231-3001 iBasket Upgrade kit "A" (1x
iBasket type "A", ConBox,
Basket Rack Assembly, Type “B”, with 3 test ZT.net), for 1st test station
stations 82-240-0011 (testing without disc)
Basket Rack Assembly, Type “B”, with 3 test 84-231-3002 iBasket Upgrade kit, "A" (1x
stations in “Quick-Clean” version iBasket type "A"), from 2nd test
82-240-0016 station station
(testing without disc)
Water Stabiliser with colour indicator,
1 bottle 80-080-0002 Disc Remover (“Spider-Arm”) for type A
80-270-0001
USB Printer interface 12-23x-xx1x
Computer package; incl. colour printer
50-271-0005
IQ/OQ/PQ documents for ZT 220/ 320 Disin-
tegration Tester 65-2x0-9999 Notebook, incl. TFT monitor, keypad, mouse
and color printer - as well as software instal-
lation and test-run 50-271-0004
Spares
Spare-Part-Kit for mBasket (glass tubes,
Spare Part Kit for ERWEKA ZT 320 Series sieves and guides discs) 90-270-0002
92-230-0000
76
ERWEKA PQ Tablets 90-240-0004
St.steel ruler for control
of stroke height
95-240-0004
St.steel ruler for control
of stroke height, num-
bered with certificate
95-270-0005
Set of 18 Distance
Plates: 0.6, 1.0 and 1.5
mm (6 plates per size),
certified
62-000-0006
1 Bottle (50) of ERWEKA PQ Tablets with
Distance plates of sizes 0.6mm, 1.0mm and 1.5
specified disintegration time to check the per-
mm (set of 9 with 3 plates per size) for special
formance of the unit, complete with certificate.
test basket (EP Application "B")
66-666-6665
65-240-0000
Qualification tool kit for ZT 220 and ZT 320
Series comprising of stop watch and st.steel
ruler with all tools in certified version
90-240-0003
Stop watch for control of
strokes/min.
95-240-0003
Stop watch for control of
strokes/min., certified
77
Tablet Friability-/ Abrasion Testers
ERWEKA TAR Series Friability Drums
Friability Drum, left for TAR
120/220, with opening for auto-
matic emptying 11-3x5-1xxx
20 – 100 rpm Abrasion Drum, right for TAR 220 (not for
Available for 1 or 2 drums automatic emptying) 11-325-x3xx
Compatible with ERWEKA friability- and
abrasion drums Abrasion Drum, right for TAR 220, num-
DC frequency motor with constant actual/ bered with certificate of compliance (not for
nominal adjustment for adjustable speed automatic emptying) 11-325-x4xx
Built in timer
Membrane function keys for pre-selection
of the test run-time in either number of
turns or time and rotation speed
2x LE display
Switching leg for 10° adjustment
78
IQ/OQ/PQ documents for ERWEKA PQ Tablets
Friability-Abrasion Testers
66-310-9999 IQ/OQ/PQ documents for
ERWEKA TAR series
90-240-0003
Stop watch for control of
run-time
95-240-0003
Stop watch for control of
run-time, certified
70-310-0000
Electronic RPM measure-
ment unit, contactless;
including reflector marks
(35)
75-310-0000
Electronic RPM measurement unit, contact-
less, calibrated with certificate; including re-
flector marks (35)
79
ERWEKA GTA 120
ERWEKA friability tester type GTA 120 de- Operation procedure according Pharm.
signed for any form of tablets, granules and Eur. Vol.17, No.3, July 2005:
pellets according to the Pharm. Eur. Excellent
reproducibility is possible due to the precise a.) Before and after measurement the grau-
constancy of the input energy and due to the les/pellets have to be sieved through a 355
irrelevance of the tackiness of the test material sieve to remove any fines.
inside the glass bottle (test station). b.) 10.00 g of the sieved granules/pellets have
The single glass bottle is fixed to a holder which to be filled into the glass bottle, then the
is connected to an arm performing the shaking bottle is capped and fixed to the holder.
(oscillation) procedure as described in the c.) The test run has to be performed as men-
Pharm.Eur. An acrylic glass lid covers the test- tioned before.
ing area. The shaking intensity and duration are d.) The bottle is removed, opened and the
manually pre-selected. granules/pellets are again sieved through a
355 sieve in order to remove the fines.
Shaking frequency 0-400 strokes/min. e.) The weight of the sieved granules/pellets is
Run time 0-9999 seconds. measured again
Shaking angle 42°. f.) The friability loss is calculated: m1 - m2
Test station complies with the regulations x100 m1
Security acrylic glass cover over the test g.) This procedure (a - f) has to be repeated 3
station times, then the average friability loss is
calculated.
100–240V/50Hz and 60Hz 12-311-0001
80
Tablet Hardness Testers
ERWEKA TBH 125 Options
Integrated Printer for results, statistics and
calibration protocol 12-42x-xx1x
81
ERWEKA TBH 325 ERWEKA TBH 325 D
The new TBH 325 series is the hardness tester Similar to the TBH 325, the ERWEKA TBH 325
with integrated product memory for up to 20 D offers the possibility to measure with the
products developed for those customers who “constant speed” and “constant force” hardness
require robust design, easy handling and fast testing principle. The required measurement
Qualification without complying 21 CFR 11 principle may be selected by the programme
regulations. menu within seconds.
Via the numeric membrane keypad with alpha- In addition to the basic TBH 325 the TBH 325 D
numeric sub function the nominal hardness in measures and documents the sample diame-
combination with 2 individual plus/minus toler- ter/length. This also allows you to document
ances and remarks may be stored for up to 20 that the sample was placed in the correct
different products and recalled for testing. In- alignment for the hardness testing process.
formation such as product name and remarks
can be entered similar to writing a message on
a mobile phone. Stored product data can be Additional features:
transmitted via SD card or USB stick to other
devices of the TBH 325/425 family. Since the Measuring range for diameter:
samples are inserted into the test station up to 28.00 mm (Version –D/28) or op-
manually all kind and shapes of samples can be tional up to 70.00 mm (Version –D/70)
tested. Calibration is completely menu guided Accuracy ± 1 N; ± 0.03 mm
and may be performed by either weight stones Values in mm or inch
or the dynamic ERWEKA AutoCal System.
Via a standard USB printer interface a printer
can be connected to receive hard copy docu- Measuring range up to 28.00 mm 13-xx6-0xxx
mentation. The serial LAN/USB interface allows
connecting a computer with the optional MC.net Measuring range up to 70.00 mm 13-xx6-1xxx
software for external control. In combination
with this, the TBH 325 series is 100% 21 CFR
11 compliant.
Up to 99 samples per test
Electronic load-cell
Tests samples up to 28 mm or 70 mm di-
ameter
Measuring range 3 – 500 N, accuracy ± 1N
Adjustable break between the samples
Two measuring principles available as stan-
dard
“Turbo” hardness test jaw, 3 times faster
than previous version
Integrated programme menu for calibration
of the unit with documentation print out
LAN/USB interface for external control and
storage of results by the optional MC.net
software
USB interface for USB stick standard
SD – Card Slot standard
USB Printer interface for documentation of
time, date, results and statistics
100-240V/50 and 60Hz 13-435-0000
82
ERWEKA TBH 325 TD ERWEKA TBH 325 WTD
Similar to the TBH 325 the ERWEKA TBH 325 Semi-automated ERWEKA combination tester
TD offers the possibility to measure with the for testing the 4 essential parameters of round
“constant speed” and “constant force” hardness and odd shaped samples (weight, thickness,
testing principles. The programme menu may diameter and hardness). The TBH 325 WTD is
select the required measurement principle based on the TBH 325 TD and offers the same
within seconds. functions (“constant speed” and “constant force”
The TBH 325 TD in addition offers automatic measurement principle etc.).
measurement of sample diameter/length and In addition an external Sartorius or Mettler ana-
semi-automatic measurement of sample thick- lytical balance with windshield (20.0 mg to 50 g;
ness. The units’ electronics are linked to a digi- accuracy ± 0.1 mg, Sartorius balance with in-
tal thickness measuring device under which the built calibration weight) is connected to the unit.
sample is placed before testing hardness and Before testing the other parameters, the sample
diameter/length. The thickness measuring is placed manually to the balance; the weight is
gauge is lowered manually and the displayed determined and transferred to the units’ elec-
result is transferred to either create a 3 parame- tronics.
ter print-out or transfer the data to a PC with the
optional MC.net software. Standard delivery range without balance; differ-
It is possible to select results in N, KP and SC ent brands and types of balances optionally
as well as mm and inch. available.
83
Options AutoCal 2.0 (Dynamic Calibration)
Sartorius CPA 64 balance incl. windshield The new AutoCal 2.0 System is an auto-
and integrated calibration weight for connec- mated calibration tool for calibration of the
tion with TBH 325 WTD 13-xx8-0xx6 hardness test station without weights and
without the need of external PC and soft-
Sartorius CPA 64 OCE balance (gaugeable) ware. With the new AutoCal 2.0 the elec-
incl. windshield and integrated calibration tronics-stick is plugged into the USB inter-
weight for connection with TBH 325 WTD face of the TBH x25 (previous series without
13-xx8-0xx7 USB interface require an adapter), the con-
nected certified load-cell inserted into the
Mettler AB 54 balance incl. windshield for hardness test station. The complete system
connection with TBH 325 WTD (adjustment and calibration) is now per-
13-xx8-0xx8 formed via the keypad and display of the
hardness tester, a report generated via the
Standard data export via LAN/USB interface standard printer interface.
82-44x-0002 The unit will automatically adjust; calibration
can be checked by linearity checking of up
Extended measuring range, 3 – 1.000 N, to 50 points within the measuring range and
accuracy ± 1N 12-xxx-x1xx documented by a connected printer.
85-450-0000
Enlarged of product memory from standard
20 products to up to 50 products Adaptor for connecting the AutoCal electron-
82-4x0-0000 ics stick to previous TBH series without USB
interface 85-410-0000
Set of test jaws for
testing sugar coatings
80-430-0001
84
Software Packages
ERWEKA MC.net Software Modification for archiving/outsourcing
MC.net data to prevent a full running in or-
The ERWEKA MC.net software is directly der to reduce the size of data base and/or
connected with the serial LAN/USB inter- increase the available storage location
face of the TBH x25 and therefore allows 50-451-0000
PC operated external control of the Hard-
ness-/Combination Tester as well as online WIN.print software
storage of user management, product
data, results as well as CFR 21/11 compli- Print software for hard-copy documentation
ant Audit Trail. at any network printer when TBH is con-
nected to the computer Network via the op-
Due to the high memory capacity of a PC tional Ethernet (LAN) adapter
the capacity of stored users, product data, 50-431-0000
results as well as CFR 21/11 Audit Trail is
nearly unlimited.
50-420-0002
85
ERWEKA TBH 425 ERWEKA TBH 425 D
Hardness Tester for automatic measurement of ERWEKA TBH 425 D is based on the TBH 425
up to 10 samples. Via the numeric membrane but in addition offers measurement and docu-
keypad with alpha-numeric sub function the mentation of the sample diameter/length.
nominal hardness in combination with 2 individ- This function allows verifying that the sample
ual plus/minus tolerances (T2 = pass/fail crite- was perfectly aligned before testing hardness.
ria) and remarks may be stored for up to 20
different products and recalled for testing. In-
formation such as product name and remarks
can be entered similar to writing a message on
a mobile phone. Stored product data can be
transmitted via SD card or USB stick to other
devices of the TBH 325/425 family. Calibration
is completely menu guided and may be per-
formed by either weight stones or the electronic
ERWEKA AutoCal System. Via a standard USB
printer interface a printer can be connected to
receive hardcopy documentation.
The serial LAN/USB interface allows connecting
a computer with the optional MC.net software
for external control. In combination with this, the
TBH 425 series is 100% 21 CFR 11 compliant.
Additional features:
10 chamber star feeder with brushes to
clean the transport way Measuring range for diameter: up to
Routine for alignment of oblong shaped 28.00 mm
samples Accuracy ± 1 N; ± 0.03 mm
Tests samples up to 28 mm diameter Values in mm or inch
Measuring range 3 – 500 N, optional 3 –
1.000 N accuracy ± 1N 100V-240V/50Hz and 60Hz 13-xx6-xxxx
Values in N, Kp or Sc
“Turbo” hardness test jaw, 3 times faster
than previous version
Numeric keypad with alpha-numeric sub-
function for entry of test parameters, prod-
uct name, batch number and remarks
Integrated menu for calibration and ad-
justment with documentation print out
LAN/USB interface for external control and
storage of results by the optional MC.net
software
USB interface for USB stick standard
SD-Card Slot standard
USB printer interface for documentation of
time, date, results and statistics
86
ERWEKA TBH 425 TD ERWEKA TBH 425 WTD
The semi-automated TBH 425 TD in addition to The ERWEKA TBH 425 WTD is based on the
the standard TBH 425 offers automatic meas- TBH 425 TD.
urement of sample diameter/length and thick- In addition an external Sartorius or Mettler ana-
ness by a motor-driven and calibratable elec- lytical balance with windshield (20 mg to 50 g;
tronic linear potentiometer. The unit can either accuracy ± 0.1 mg; Sartorius balance with in-
fulfil a 3 parameter hard-copy print-out by a built calibration weight) may be connected to
connected printer (optional) or transfer the data the unit. Before testing the other parameters,
to a PC with the optional MC.net software. the sample is placed manually onto the bal-
ance, the weight is determined and transferred
to the units’ electronics.
Additional features:
Additional features:
Automatic measurement of hardness,
thickness and diameter/length Measuring range for weight (dependant on
Measuring range for thickness: up to balance): 20 mg – 50 g
10.00 mm Accuracy ± 1N; ± 0.03 mm; ± 0.1 mg
Accuracy ± 1 N; ± 0.03 mm Values in mm or inch, mg or g
Values in mm or inch
100V-240V/50Hz and 60Hz 13-xx8-xxx5
100V-240V/50Hz and 60Hz 13-xx7-xxxx
87
Options AutoCal 2.0 (Dynamic Calibration)
Sartorius CPA 64 balance incl. windshield The new AutoCal 2.0 System is an auto-
and integrated calibration weight for connec- mated calibration tool for calibration of the
tion with TBH 425 WTD 13-xx8-0xx6 hardness test station without weights and
without the need of external PC and soft-
Sartorius CPA 64 OCE balance (gaugeable) ware. With the new AutoCal 2.0 the elec-
incl. windshield and integrated calibration tronics-stick is plugged into the USB inter-
weight for connection with TBH 425 WTD face of the TBH x25 (previous series without
13-xx8-0xx7 USB interface require an adapter), the con-
nected certified load-cell inserted into the
Mettler AB 54 balance incl. windshield for hardness test station. The complete system
connection with TBH 425 WTD (adjustment and calibration) is now per-
13-xx8-0xx8 formed via the keypad and display of the
hardness tester, a report generated via the
Standard data export via LAN/USB interface standard printer interface.
82-44x-0002 The unit will automatically adjust; calibration
can be checked by linearity checking of up
Groove in the hardness test station for better to 50 points within the measuring range and
alignment of oblong shaped samples documented by a connected printer.
12-44x-1xxx 85-450-0000
Stainless steel magazine plate Adaptor for connecting the AutoCal electron-
12-44x-xxx2 ics stick to previous TBH series without USB
interface 85-410-0000
Extended measuring range, 3 – 1.000 N,
accuracy ± 1N 12-xxx-x1xx Spare part kit for ERWEKA TBH 425/525
92-450-0000
Increase of product memory from standard
20 products to up to 50 products
82-4x0-0000
Special Versions
Set of test jaws for
testing of sugar coat- 12-44x-xx1x Special version of ERWEKA
ings TBH 425 with 20 chambers,
80-430-0001 st.steel feeder and transport-
way for testing fertilisers
88
ERWEKA TBH 525
different products and recalled for testing. In-
formation such as product name and remarks
can be entered similar to writing a message on
a mobile phone.
89
Options group including additional rights for indi-
vidual users etc. Since, due to CFR 21/11
Diameter/Width Measurement (measuring users can not be deleted from the memory
range 0.10 to 26.00 mm with an accuracy the MC.net software allows to switch users
of +/- 0.03 mm) 14-xx6-xxxx inactive and, on request, only to display
active users.
Thickness Measurement (measuring range
0.10 to 12.00 mm with an accuracy of +/- Similar to users the MC.net software al-
0.03 mm) 14-xx7-xxxx lows to switch product data inactive and,
on request, only to display active product
Weight Measurement, integrated, incl. data.
Sartorius weighing cell 14-xx8-xxx5
The MC.net software is a tool to create
Extended Measuring Range, 800 N various statistical reports from the test-
12-45x-x1xx results, such as test-run statistics, graphi-
cal batch statistics, trend analysis etc.
Increase of product memory from standard
20 products up to 50 products The integrated CFR 21/11 compliant Audit
82-4x0-0000 Trail tool of the MC.net software automati-
cally stores all Audit Trail data of the con-
Spare Part Kit for TBH 525 nected unit.
92-550-0000 The Audit Trail data may be sorted accord-
ing to date or user/user group, displayed
and printed for hard-copy documentation.
In order to prevent a full running data base
please see option 50-451-0000.
Software Packages 50-420-0000
90
Function:
ERWEKA MultiCheck 5.1 The samples are individualised automatically by
a new system for separation of the samples via
an oscillating funnel and then deposited onto
the weight measurement boat. From there the
samples are transported to the test stations by
a linear feeder which allows alignment of ob-
longs as well as odd shaped samples such as
sugar coatings. In case of problematic samples
a down holder in the hardness test station is
available as an option. A patented step in the
transport way allows you to switch tablets which
tend to lie on the side.
91
Important Information
- The area in front of the hardness and under Measuring range 3 – 500 N, optional 3 –
the width measurement station should be 1.000 N, thickness up to 12.0 mm
always dust-free and free of damage. We Accuracy ± 1N, ± 0.03 mm and ± 0.1 mg
recommend scheduled service (approxi- In combination with the Sartorius weighing
mately every 300 operating hours) from an cell the MultiCheck 5.1 offers an accuracy of
ERWEKA service engineer or qualified per- +/- 0.1mg, in combination with the CPA 64
sonnel OCE (gaugeable) the accuracy is even 10
times higher (+/- 0.01mg)
- We recommend pre-adjustment with PQ Ethernet network connection of the unit
tablets in our service department
92
Options PC in ERWEKA standard configuration
(brand name PC in minitower housing, CPU
Down Holder for alignment of difficult to Intel Pentium Dual Core 2 Duo with mini-
position samples including one standard mum 2.6GHz, Hard disk with minimum 250
universal down holding tool for oblong GB, Main Memory with minimum 2048 MB, 3
shaped tablets. 80-455-0000 serial interfaces, 6 USB 2.0 interfaces, 16x
DVD-ROM device, Windows XP, keyboard,
Down holding tool customized scroll mouse and 19'' flat screen TFT moni-
80-455-0004 tor) 80-430-0009
Electronically adjustable step before the Spare Part Kit for MultiCheck 5.1, including
thickness measurement station to drop fuses, initiator, toothed belt and reflex button
samples to the right side 2x-45x-xx1x 94-460-0001
Housing made of
stainless steel
82-455-0001 AutoCal 2.0 (Dynamic Calibration)
The new AutoCal 2.0 System is an auto-
mated calibration tool for calibration of the
Picture shows MultiCheck V hardness test station without weights and
without the need of external PC and soft-
Additional price Sartoruis Balance with dis- ware. With the new AutoCal 2.0 the elec-
play instead Sartorius weighing cell tronics-stick is plugged into the USB inter-
82-455-9001 face of the TBH x25 (previous series without
USB interface require an adapter), the con-
Additional price gaugeable balance, type nected certified load-cell inserted into the
Sartorius CPA 64 OCE instead of standard hardness test station. The complete system
weighing cell 82-455-9000 (adjustment and calibration) is now per-
formed via the keypad and display of the
Extended measuring range of up to 35mm hardness tester, a report generated via the
diameter 1x-45x-1xxx standard printer interface.
The unit will automatically adjust; calibration
Capsule system (weight determination) can be checked by linearity checking of up
1x-45x-xxx1 to 50 points within the measuring range and
documented by a connected printer.
Extended measuring range (3-1.000 N) with 85-450-0000
± 1N accuracy; test-speed up to 2.30
mm/sec. 1x-45x-x1xx AutoCal recalibration with calibration certifi-
cate 36-441-0010
ERWEKA MC.net Software for the external
control of the MC 5.1 system and the online
storage of user management data, measur-
ing results as well as CFR21/11 compliant
audit trail data 50-420-0000
93
Tablet Press Connection Calibration/Qualification tools
for diameter and thickness
82-455-0001 TabSelect (for the connection
of tablet press with MC 5.1) measuring station
80-421-0010
80-455-0002 Venturi Transport System VTS-
1.0 mm block, st.steel
1 with interface, deduster not
included 85-421-0010
1.0 mm block, st.steel
80-455-0003 AutoDoc Software package, with certificate
MC.net software
L 80-421-0030
3.0 mm block, st.steel
IQ/OQ/PQ documents for Tablet
85-421-0030
Hardness Testers 3.0 mm block, st.steel with certificate
67-421-9999 IQ/OQ/PQ documents for 80-421-0050
ERWEKA TBH 125 series in 5.0 mm block, st.steel
English language
85-421-0050
63-425-9999 IQ/OQ/PQ documents for 5.0 mm block, st.steel with certificate
ERWEKA TBH 325/425/525 se-
ries in English language 80-421-0100
10.0 mm block, st.steel
67-455-9999 IQ/OQ/PQ documents for
ERWEKA MultiCheck 5.1 and 85-421-0100
MC.net software 10.0 mm block, st.steel with certificate
Calibration/Qualification tools
IQ/OQ/PQ tools for Tablet
for weight measuring station
Hardness Testers
85-423-0050
80-440-0002 Calibration weight 50.0 g, class F1, calibrated
Qualification Tablets for MultiCheck, plastics with certificate
85-440-0002 85-423-0100
Qualification Tablets for MultiCheck, plastic, 100 mg weight,
numbered with certificate Class F1, cali-
brated with cer-
80-440-0003 tificate
Qualification tablets
for MultiCheck, 85-423-0500
st.steel 500 mg weight, class F1, calibrated with certifi-
cate
85-440-0003 85-423-0001
Qualification tablets for MultiCheck, st.steel, 1.0 g weight, class F1, calibrated with certificate
laser numbered with certificate
94
Hardness Test Station ERWEKA PQ Tablets
Static Calibration Tools
80-420-0500
Calibration weight, 5.0 kg, class M3
85-420-0500
Calibration weight, 5.0 kg, class M1, calibrated
with certificate
80-420-1000
Calibration weight, 10.0 kg, class M3
85-420-1000
Calibration weight, 10.0 kg, class M1, cali-
brated with certificate
1 Bottle (75) of ERWEKA PQ Tablets with
specified weight, hardness, diameter and
80-420-2000
thickness to check the performance of the
Calibration weight, 20.0 kg, class M3
unit, complete with documentation.
66-666-6666
85-420-2000
Calibration weight, 20.0 kg, class M1, calibrated
with certificate
85-450-0000
95
Powder and Granulate Testers – Bulk Density
The ERWEKA GTL is the basic ERWEKA unit The ERWEKA GT has been designed to offer
for testing the flow characteristics of powders either measurement of flow time according to
and granulates. It is equipped with an ex- specified amount (weight or volume) or amount
changeable stainless steel hopper (200 ml) with (weight) according to specified time. It is
exchangeable outlet nozzle (3 sizes of nozzles equipped with an exchangeable stainless steel
standard: 10.0, 15.0 and 25.0 mm; 3 different hopper (480 ml) and exchangeable out-let noz-
sizes optional). The pre-weighed sample is zle (3 sizes of nozzles standard: 10.0, 15.0 and
filled into the hopper and a light sensor located 25.0 mm; 3 different sizes optional) as well as a
under the outlet of the hopper measures the balance located under the outlet of the hopper.
flow time. The product data is entered via the alpha-
When determination of flow time of the sample numeric keypad, results are shown on the illu-
volume is requested, two additional stainless minated 320 digit full-graphic LC display and
steel hoppers with different volumes are avail- can be printed out using the standard parallel
able as an option. printer interface or transferred to a PC via the
The unit is controlled via the numeric mem- standard RS 232 interface.
brane keypad, results are shown by the illumi-
nated 4-line LC display. 100-240V/50-60 Hz 10-451-0000
100-240V/50-60 Hz 11-450-0000
Options
When testing the characteristics of products
Options with poor flow the unit can be equipped with
a stirrer in the hopper 10-451-1xxx
Set of 3 outlet nozzles with outlet diameter
6.0, 8.0 and 11.3 mm, stainless steel Set of 3 outlet nozzles
80-450-0003 with outlet diameter
6.0, 8.0 and 11.3
Stainless steel hopper, mm), stainless steel
480 ml volume 80-450-0003
80-450-0480
Stainless steel hopper, 100 ml volume
80-450-0100
Stainless steel hopper, 100 ml volume Stainless steel hopper, 200 ml volume
80-450-0100 80-450-0200
96
ERWEKA GTB IQ/OQ/PQ documents for
Granulate-Flow Testers
66-450-9999 IQ/OQ/PQ documents for
ERWEKA GTL; GT; GTB
66-451-9999
Qualification Tool Kit for GT comprising of stop
The ERWEKA Flow ability Tester, Type GTB is watch and weights for balance
based on the GT but also measures and docu-
ments the angle of repose optically (by laser). 66-452-9999
Qualification Tool Kit
100-240V/50-60 Hz 10-452-0000 for GTB comprising
of 66-451-9999 plus
special cones for
Spare Part Kit for GTB 92-457-0000 laser Qualification
85-451-0000
Calibration weights (2x 2.0 kg) for readjust-
Options ment of the integrated balance (GT and
GTB only)
When testing the characteristics of pow-
ders or granulates with poor flow the
ERWEKA GTB can be equipped with a
stirrer in the hopper 10-452-1xxx ERWEKA SMG
Set of 3 outlet nozzles with outlet diameter
6.0, 8.0 and 11.3 mm, stainless steel
80-450-0003
97
Powder & Granulate Testers – Tapped Density
ERWEKA SVM 121 and 221 ERWEKA SVM 122 and 222
The ERWEKA SVM 121 (one test station) and ERWEKA Tapped Density Testers, Type SVM
SVM 221 (two test stations) meet the specifi- 122 and SVM 222 are equal to SVM 121 and
cations of USP apparatus 1 (stroke height 221 but designed to meet the specifications of
15 mm, 300 strokes per minute tapped metal on USP apparatus 2, Phar.Eur. and DIN ISO EN
metal). The test run duration can be adjusted 787, part 11 (stroke height 3.0 mm, 250 ± 15
either in time or strokes (up to 99.999) by strokes per minute).
membrane function keys. The remaining test
run-time as well as actual stroke are shown on
the illuminated 2 LE displays (the standard unit
is delivered without glass-ware).
SVM 121 (one test station) SVM 122 (one test station)
100-240V/50-60 Hz 12-453-1000 230V/50Hz 12-454-1001
230V/60Hz 12-454-1002
115V/60Hz 12-454-1003
SVM 221 (two test stations) 127V/60Hz 12-454-1004
100-240V/50-60 Hz 12-453-2000
98
ERWEKA SVM 223 Glassware for SVM Series
(only two test stations) All ERWEKA Glass Cylinders are with adaptor
kit according to USP or EP
Options
USB printer interface adapter for standard
parallel printer port (PCL) 80-270-0000
99
Suppository Testers
ERWEKA Suppository ERWEKA Circulation
Hardness Tester, Type SBT 2 Heater, EST 2
230V/50Hz 10-466-5001
Suppository Hardness Tester comprising of an 230V/60Hz 10-466-5002
electrical heated chamber with a number of 115V/60Hz 10-466-5003
inserts to accept various size of suppositories. 127V/60Hz 10-466-5004
The hardness is checked by weights (included
in the standard delivery range) which are added
until the suppository collapses. ERWEKA Suppository
Penetration Tester, Type
230V/50Hz 11-465-0001
230V/60Hz 11-465-0002 PM 30
115V/60Hz 11-465-0003
127V/60Hz 11-465-0004 Suppositories must dis-
integrate, dissolve or
melt at body tempera-
ERWEKA Suppository Melt- ture.
ing Point Tester, Type SSP The ERWEKA PM 30 is
designed to deliver re-
The SSP consists
producible results for
of a graduated tube
softening time of sup-
(test chamber). The
positories.
sample to be tested
The unit comprises of three glass test tubes
is placed in a spiral
each for 1g, an acrylic glass water bath and an
shaped glass test
immersion thermostat (1.500 Watts at 230V,
basket inside the
test chamber, 1.000 Watts at 115V, accuracy ± 0.5°C). The
which is sur- water bath temperature is displayed by an im-
rounded by a water mersion thermometer.
heating tube. For
heating of the PM 30 acc. to EP App. A
water inside the heating jacket, ERWEKA offers 230V/50Hz 11-467-0001
an optional Circulation Heater, Type EST 2. 230V/60Hz 11-467-0002
115V/60Hz 11-467-0003
SSP 10-466-0000 127V/60Hz 11-467-0004
100
ERWEKA Suppository
Options for PM Disintegration Tester,
Glass test tubes, 2g, with adaptor, for PM 30 Type ST 32
acc. to EP App. B 81-000-1001 The ST 32 is a basic
suppository disintegra-
Glass test tubes, 3g, with adaptor, for PM 30 tion tester and complies
acc. to EP App. B 81-000-1002 with the latest EP
specifications. The unit
Immersion thermometer with certificate (in- comes with 3 test sta-
stead of non-certificated immersion ther- tions, either located in-
mometer) 75-001-0003 side a thermostatically
heated 12 liter water
Water Stabiliser with colour indicator, bath.
1 bottle for 2 fillings 80-080-0002 The test stations are automatically turned 180°
in adjustable intervals. ST 32 features an inte-
Spare part kit for PM 30 acc. to EP App. B, grated "high-power" flow-through heating sys-
comprising of glass test chamber with ac- tem (accuracy ± 0.2°C) and internal tempera-
cessories 91-467-0000 ture sensor for temperature display. Test time
and nominal bath temperature is entered via the
membrane keys. Current test time as well as
actual water temperature are shown on clearly
visible red LEDs.
On request, an alarm may be selected to sound
upon completion of the preset test time.
230V/50Hz 10-469-0001
230V/60Hz 10-469-0002
115V/60Hz 10-469-0003
127V/60Hz 10-469-0004
Options for ST 32
Water Stabiliser with colour indicator, 1 bot-
tle for 2 fillings 80-080-0002
101
ERWEKA Suppository IQ/OQ/PQ documents
Disintegration Tester, IQ/OQ/PQ Document SBT 65-465-9999
Type ST 35 IQ/OQ/PQ Document SSP 65-466-9999
IQ/OQ/PQ Document PM 30 65-467-9999
In contrast to IQ/OQ/PQ Document ST 32 65-469-9999
the ST 32, the IQ/OQ/PQ Document ST 35 65-470-9999
ST 35 comes
with each test
station located IQ/OQ/PQ tools
inside a 4 liter
glass vessel Stop watch 90-240-0003
(with optional Stop watch, certified 95-240-0003
magnetic stirrer) which are placed inside a Immersion Thermometer cert. 75-001-0003
thermostatically heated water bath (leak-free,
double secured). The test stations are automat-
ically turned 180° in adjustable intervals. ST 35
features an integrated "high-power" flow-
through heating system (accuracy ± 0.2°C) and
internal temperature sensor for temperature
display. Test time and nominal bath tempera-
ture is entered via the membrane keys. Current
test time as well as actual water temperature
are shown on clearly visible red LEDs.
On request, an alarm may be selected to sound
upon completion of the preset test time.
230V/50Hz 10-470-0001
230V/60Hz 10-470-0002
115V/60Hz 10-470-0003
127V/60Hz 10-470-0004
Options for ST 35
Set (3) of magnetic stirrers, controlled by the
membrane keys of the unit
10-470-500x
102
All-Purpose-Equipment
1. Motors
1.1. AR 403 1.3. AMD
This Drive Unit features a 230V (single phase)
or 400V (three phase) asynchronous motor. It is
adjustable between 46 and 410 rpm by means
of a lockable hand wheel.
AMD
230V/50Hz (single phase) 10-503-0001
400V/50Hz (three phase) 10-503-0031
230V/60Hz (single phase) 10-503-0002
400V/60Hz (three phase) 10-503-0032
115V/60Hz (single phase) 10-503-0003
200V/60Hz (three phase) 10-503-0033
The sturdy ball bearing worm gear drive is Other voltage is available on request.
completely maintenance free and provides an
output torque of max. 30 Nm. The unit features
electronic speed control variable between 0 and Options for AR 403/-S and AMD
400 rpm.
The Speed is regulated by a digital dial. By a
Foot Switch for ON/OFF of the above men-
permanent nominal/actual adjustment the pre-
tioned motor drives 11-507-0000
selected speed is kept, even under varying
load.
AR 403 USB interface for print out
The AR 403-S is similar to the AR 403 but of-
80-503-0000
fers a different connection to the attachment.
This connection is designed for better transfer
OQ Tools (adapter, holding fixture, clip,
of the torque. It can be used with some of the
revolution counter Shimpo PH-200L),
ERWEKA attachments.
certified 80-502-0001
Tolerance time: +/- 1 sec
IQ/OQ/PV documents AR 403/-S
Tolerance RPM: +/- 1 RPM
66-503-9999
230V/50Hz 14-502-0001
230V/60Hz 14-502-0002
115V/60Hz 14-502-0003
127V/60Hz 14-502-0004
1.2. AR 403-S
The AR 403-S is similar to the AR 403 but of-
fers a different connection to the attachment.
This connection is designed for better transfer
of the torque. It can be used with some of the
ERWEKA attachments.
230V/50Hz 14-502-1001
230V/60Hz 14-502-1002
115V/60Hz 14-502-1003
127V/60Hz 14-502-1004
103
2. Attachments
Universal Gear, UG Homogeniser, HO/HHO
PRS 10-512-0000
DER (vessel with heater) 80-512-0000
DW (vessel with double jacket) 80-512-5000
104
Laboratory Kneader, LK5 Filling and Dosing Machine for
Liquids, FDF
FDF 10-516-0000
Suppository and Lipstick DP 30 (2), 5-30 ml 80-516-0010
Moulding Machine, SG 4/W DP 150 (2), 20-150 ml 80-516-0020
Filling Nozzles (2), 6 mm 80-516-0001
Filling Nozzles (2), 8 mm 80-516-0002
FDS 10-517-0000
Dosing 0.5 to 25 ml 80-517-1000
Dispense heads for tubes 80-517-2000
105
Ball Mills, KM Drum Hoop Mixer, RM
106
Vibration Sieve Shaker, VT
Reciprocating Sieve set compris-
cam system. The ing of 4 sieves (315
intensity of the µm; 71 µm; 1,25
shaking action mm; 2,0 mm MW)
can be adjusted acc. to ISO 9044,
by the speed of 20 cm diameter,
the motor drive. made of st.steel,
Different sieve sets can be fitted to the sieve Type PS/S
shaker. 10-521-0000 80-521-0002
Sieve Inlays, Mesh of Stainless Steel Mesh DIN DKE, st.steel pan, volume 9.5 l., max. capacity
4189 fixed with wire ring. 30%, 275 mm outside diameter 10-522-0001
Mesh 180 µm 80-521-1180 DKS, st.steel pan, volume 15.0 l., max. capacity
Mesh 250 µm 80-521-1250 30%, 350 mm outside diameter 10-522-0002
Mesh 355 µm 80-521-1355
Mesh 500 µm 80-521-1500 Infra red drying attachment 80-522-0000
Mesh 710 µm 80-521-1710
Mesh 1,40 mm 80-521-1140 Spare bulb for above 90-522-0000
Mesh 2,00 mm 80-521-1200
Mesh 2,80 mm 80-521-1280
Mesh 4,00 mm 80-521-1400
107
Polishing Drum Dry Granulator, St. Steel,
TG 2000
108
Cube Mixers, KB Conical Mill, CM 60/UD
Is a product in feed
system for applica-
tion for develop-
ment in pharma-
ceutical and food
industry which
comminute pow-
dery and free-
flowing products by
Mixing by tumbling action to produce homoge- a sieve (adjustable 0.3 – 3.0 mm; perforated
nous blend. Because of the gentle mixing action round holes, grater holes or square holes; see
the mixer may be used sensitive products. The list) with fixed maximum sizes of impurity-free
mixing action is assisted by three st.steel rods granule.
strategically positioned within the cube. The Rotation speed (continuous 60 – 1200
Cube Mixer is available in two sizes, made of revs/min) and sieve crack (standard 1.5 mm,
acrylic glass or st.steel. Max. capacity is 40% of adjustable 0.5 – 3.0 mm in 0.25 mm steps) can
the total volume of the cube. be varied for detailed adjustment of process.
A Universal Gear is needed to attach the Cube 10-527-0000
Mixer to the motor drive in order to be able to
change the angle. Options
KB 15, made of acrylic glass, 3.5 l volume Material certificate for all product contacting
10-526-0015 parts 85-527-9999
KB 15 S, made of st.steel, 3.5 l volume Rotor type I (square shaped impeller bars)
10-526-1015 80-527-0100
KB 20, made of acrylic glass, 8.0 l volume Rotor type IV (round shaped impeller bars)
10-526-0020 80-527-0200
KB 20 S, made of st.steel, 8.0 l volume Rotor type V (slanted impeller bars)
10-526-1020 80-527-0300
KB 30 made of acrylic glass, 11 l volume Rotor type VI (small shovel type impeller
10-526-0030 bars) 80-527-0400
KB 30 S made of st. steel, 11 l volume Rotor type VII (quarter-circle shaped impel-
10-526-1030 ler bars) 80-527-0500
Rotor type VIII (a large shovel type impeller
bars) 80-527-0600
High Speed Mixer, SW 1/S
Sieve/screen inserts
Round holes RL 0,5 mm
80-527-1000
Round holes RL – 0,6 – 0,8 mm
80-527-2000
Round holes RL – 1,0 – 1,4 mm
80-527-3000
Round holes RL – 1,5 – 2,5 mm
Drum mixer operating on the plough-share prin-
80-527-4000
ciple and designed to mix powders, granules
Friction holes RR – 1.0 – 1,2 mm
and other products of a fibrous nature. Quantity
ratios of 1:100.000 can be mixed homoge- 80-527-5000
nously in just a few minutes. The mixing drum Friction holes RL – 1,5 – 2,5 mm
has a removable cover and can rotate through 80-527-6000
Friction holes RR – 3.0 mm
180 degrees for loading and emptying. All parts
80-527-7000
coming into contact with the material are made
of st.steel. Square holes QL– 1,5 – 2,5 mm
The mixing drum has a volume of 5.0 l and a 80-527-8000
max. capacity of approx. 70%.
SW 1/S 10-530-0000
109
Tablet Presses
Single Punch Tablet Press, Options for Tablet Press,
EP-1 Type EP-1
Measurement and display of compression
force 72-xxx-1xxx
EP-1 72-531-0000
110
16-Station Rotary Tablet Options for TR-B 16
Press ERWEKA TR-B 16
Set (18) of round tooling, diameter to be
agreed 80-532-0001
16 stations
Tooling EU (IPT) “B”
For round and shaped tablets
Max. Diameter 18 mm,
18 mm x 9 mm for shaped tablets
Max. Filling Depth 17 mm
-1
Die Table 10 - 40 min
Die Table Stainless steel (1.2530)
O-ring punch seals for upper sleeves
Turret with keyways in upper guides
Output up to 38.400 samples/hr.
Max. Compression force 40 kN
Max. Pre-Compression force 6 kN
Upper punch penetration 3 mm
Voltage 380 – 3 Ph – 50 Hz
H/D/W (mm): 1200/460/670
Net weight: 380 kg
111
8-Station Rotary Tablet
Press ERWEKA TR-D 8
Options for TR-D 8
8 stations
Tooling EU (IPT) “D”
For round and shaped tablets
Max. Diameter 25 mm,
22 mm x 10 mm for shaped tablets
Max. Filling Depth 17 mm
-1
Die Table 10 - 40 min
Die Table stainless steel (1.2530)
O-ring punch seals for upper sleeves
Turret with keyways in upper guides
Output up to 19.200 samples/hr.
Max. Compression force 40 kN
Max. Pre-Compression force 6 kN
Upper punch penetration 3 mm
Voltage 380 – 3 Ph – 50 Hz
H/D/W (mm): 1200/460/670
Net weight: 380 kg
112
Accessories and Instrumenta-
tion of TR-B 16/TR-D 8
Device for upper compression force meter
and recorder (upper roller). Strain-gauge
load cell fitted in the shaft, which supports
the upper compression roller (complete with
single amplifier) to be connected to com-
puter with software 75-532-0001
113
ERWEKA Roller Compactor Options
IQ/OQ/PQ document for Roller Compactor
66-456-9999
230V/50Hz 13-456-0001
230V/60Hz 13-456-0002
115V/60Hz 13-456-0003
127V/60Hz 13-456-0004
114
ERWEKA Fluid Bed System Options
FB-05 Mobile undercarriage to place the FB-05.
Table approximate dimensions: width/
depth/height: 1000mm/800mm/900mm
80-602-0005
The very compact „FB-05“ has been designed Peristaltic pump to transport the spray liquid
for drying, granulating and coating of quantities from a spray medium tank to the spray noz-
from 50 to 750 ml (optional from 5 to 100 ml, zle. Used by granulating and coating.
see also Micro-Kit). 80-602-0007
Special care has been taken to offer easy han-
dling and fast cleaning to make this unit the Temperature measurement instrument with
ideal partner for use in research and develop- digital display. It can be used alternatively
ment departments. for one of both gauge connections.
This advanced fluid bed offers perfect flow 80-602-0008
properties to be able to work even with difficult
products in very small batch sizes. The unique Expansion chamber made of borosilicate
spay nozzle has been developed to work with glass instead of Plexiglas (solvent resistant)
very small quantity of product. Outlet air is fil- 80-602-0009
tered by metal filter cartridges. All parts which
come in contact with the product are made of Spray nozzle insert, 0,3mm 80-602-0010
high-grade steel (AISI-316L).
Spray nozzle insert, 0,8mm 80-602-0011
230V/50Hz 71-602-0001
115
Universal Automated
Documentation for all kind
of Rotary Tablet Presses
Dedusters
Different Dedusters are available for TRB 16
and TRD 8. Please contact our Sales Depart-
ment for information.
230V/50Hz 10-600-0001
230V/60Hz 10-600-0002
115V/60Hz 10-600-0003
127V/60Hz 10-600-0004
116
Blister Density Checker
Options for VDT/S
ERWEKA Vacuum Density Upgraded electronic with USB printer inter-
Tester, Type VDT/S face for documentation of the test procedure
11-630-1xxx
To verify the function of blister packaging ma- Spare Part Kit 92-630-0000
chines ERWEKA offers the Vacuum Blister
Density Tester, Type VDT/S.
The unit is equipped with an integrated vacuum
pump.
Pressure (-200 mbar and -850 mbar, dependant
on weather condition and size of container) and
time (up to 99 min., 59 sec.) are adjustable by
the membrane function keys. The two bright LE
displays show remaining test run-time and ac-
tual pressure.
The blister is placed in the external pressure
container, which is filled with liquid. Different
sizes of containers are available.
117
Services
Installation
Installation of most ERWEKA units (TAR, SVM, Qualification
ZT, TBH or DT) is easy and can be achieved by
the user himself or an engineer of the company. ERWEKA offers Installation Qualification (IQ),
Operation Qualification (OQ) and Performance
For more sophisticated products such as Disso- Verification (PV) documents for all its testing
lution Systems ERWEKA offers complete tubing units.
kits and even pre-configuration. The user or the These documents allow the user to validate/
engineer has to connect the tubing and plug the qualify the equipment independently by follow-
numbered interface cable in the equivalent ing the instructions and filling in the attached
numbered sockets only. forms.
To outsource the Qualification/Qualification
For a perfect installation and training of the procedure, ERWEKA offers installation as well
user/s, ERWEKA offers a complete installation as Operation Qualification and Performance
service by an ERWEKA engineer. This means Verification (IQ/OQ/PV) services on site. Our
the unit or system will be installed at your site, trained Service performs the complete
the operation will be checked and the user/s IQ/OQ/PV for you as well as training the users
receive a training in the operation of the unit to operate the equipment. This service ensures
and (when needed) software. perfect installation and worry free operation.
118
Calibration Maintenance
Before shipping all ERWEKA Hardness- and To ensure a long lifetime for your units
Combination Testers as well as all electronic ERWEKA recommends regular maintenance.
temperature sensors are calibrated. The cali-
bration documentation comes with the unit. Dissolution Testers of the new generation are
equipped with a Service Interval Display, which
For re-calibration ERWEKA units come with a reminds the user every 3.000 hours of opera-
calibration menu in the standard firm-ware. On tion (stirring action), that maintenance is rec-
some of the equipment the calibration menu is ommended.
password protected to assure that only qualified
staff can re-calibrate the unit. Maintenance contracts are available. Our well-
trained service engineers perform the mainte-
For perfect operation and assurance of accu- nance.
rate results, ERWEKA offers Calibration Ser-
vices on site by trained ERWEKA Service Man-
agement staff. All calibration tools used by
ERWEKA are constantly checked. Certificates
Leasing
can be shown before the calibration procedure
takes place. Not to invest capital ERWEKA offers leasing of
its equipment in co-operation with well-known
For Tablet-Hardness Testers ERWEKA now international banks.
offers a dynamic Calibration Tool which allows
calibration of the electronic load cell without Leasing is normally possible from a purchasing
weights! The so-called AutoCal System uses a amount of approx. € 10.000,00.
certified external load cell and (optionally) cali-
bration software for easy and more accurate
calibration within max. 5 minutes. In addition Used Equipment
the unit will be calibrated at up to 50 points
within the measuring range for assurance of ERWEKA also buys and sells used equipment.
results throughout the testing range. Results of When purchasing new ERWEKA equipment
calibration can be printed out and/or stored by ask, maybe we are interested to take back your
the computer. previous unit.
The system can be bought for self-calibration or
be used when having a calibration con-tract. These units will be completely refurbished, not
just painted!
Re-calibration contracts are available either
monthly, every 3 months, every 6 months or So when you need good equipment but your
once a year. budget is limited, ask for used equipment.
119
Dissolution Testing – General Information
Major organizations and groups that influence disso- Official Methods of Dissolution Testing and the cor-
lution testing standards in the US: responding ERWEKA equipment:
In the United States, Dissolution testing for pharmaceuti- United States Pharmacopoeia: USP XXVI (26)
cal products in tablet and capsule form is required by the European Pharmacopoeia: Ph.Eur 7 th Edition
US Food and Drug Administration (FDA). The standards British Pharmacopoeia: BP
for testing are put by the US Pharmacopoeia (USP). Japanese Pharmacopoeia
Testing procedures are described in USP general chap-
ters under Dissolution <711> and Drug Release <724>. USP Apparatuses:
These standards offer different test apparatuses to use
according to the nature of the dosage form. USP Apparatus 1: Rotating Basket
USP Apparatus 2: Paddle
U.S. Pharmacopeia (USP) USP Apparatus 3: Reciprocating Cylinder
The United States Pharmacopeia (USP) is a nongovern- USP Apparatus 4: Flow-Through Cell
mental, standards-setting organization that advances USP Apparatus 5: Paddle over Disc
public health by ensuring the quality and consistency of USP Apparatus 6: Rotating Cylinder
medicines, promoting the safe and proper use of medica- USP Apparatus 7: Reciprocating Holder
tions, and verifying ingredients in dietary supplements.
USP provides standards for more than 4,000 prescription ERWEKA Dissolution Testers for USP apparatus 1
and non-prescription drugs, dietary supplements, veteri- (Basket), 2 (Paddle), 5 (Paddle over Disc) and 6 (Ro-
nary drugs and health care products. These standards tating Cylinder) are available in 2 standard versions,
are published in the United States Pharmacopeia and namely DT DT 720 and DT 820 series with 8
National Formulary (USP–NF). www.usp.org. USP/Pharm.Eur. vessels (1.000 ml or 2.000 ml volume)
and 6, 7 or 8 test stations (stirrers).
US Food and Drug Administration (FDA) Most ERWEKA Dissolution Testers are available in 2
The FDA’s major contribution to dissolution testing is its versions, "Low-Head" for easy manual sampling as well
issuance of numerous documents titled “Guidance for as automated sampling and low evaporation (max. 0.3%
Industry” that describe how to apply the similarity factor. within 24 h at 37.0°C) and "High-Head" for maximum
The similarity factor is used to compare the dissolution access to the vessels during the complete test run.
profiles of different batches to assess or establish bio- Special versions with 3 test stations of 4.000 ml and 1 test
equivalence. station of 1.000 ml (reference) as well as Dual Dissolution
The FDA co-sponsors many workshops (e.g. from AAPS) Testers with 16 USP/Pharm.Eur. vessels and 12 or 14
and conferences on current regulatory issues. test stations (stirrers) can be supplied.
www.fda.gov.
ERWEKA Flow-Through-Cell Dissolution Testers for
Fédération Internationale Pharmaceutique (FIP) USP apparatus 4 are specifically made for those prod-
FIP is a world-wide federation of national pharmaceutical ucts which require long term tests (i.e implants) and
(professional and scientific) associations, which has a products which need a high amount of media volume to
mission to represent and serve pharmacy and pharma- dissolve (see page 72).
ceutical sciences around the globe. FIP spearheaded the
writing of the Guidelines for Dissolution Testing of Solid The perfect unit for multiple media change is the
Oral Products. The guidelines were published as a joint CALEVA BIO-DIS which complies with USP apparatus
report with Canada’s Official Laboratories and Medicines 3 and optional apparatus 7.
Control Services and FIP’s Section of Industrial Pharma- It is the perfect equipment for multiple pH change due to
cist. The main focus of the FIP Dissolution Working Group the 6 rows of vessels, 6 test stations and 2 Reference
is to provide a forum for discussion of dissolution issues Positions each, located in a thermostatically heated water
and to train dissolution analysts. The working group has bath.
sponsored and held many training workshops on dissolu-
tion testing. Workshops were held in Vietnam and in
Thailand.The equipment was made available by
ERWEKA on both workshops.
Homepage: www.fip.org.
120