September 7, 2016 LATEST NEWS SOP on Quality Risk Management Search...

Home Production QA & QC Engineering Warehouse Validation & Qualification Media And Video Guideline Contact Us Jobs

YOU ARE AT: Home Validation & Qualification Other DESIGN QUALIFICATION OF FLUID BED PROCESSOR

FOR FREE UPDATE

Load Banks from Mosebach
Loadbanks, AC and DC, resistive and reactive, from 50 kW to 50 MW Email *

Subscribe

DESIGN QUALIFICATION OF FLUID BED PROCESSOR 1

BY PHARMACEUTICAL GUIDANACE ON AUGUST 20, 2016 OTHER, VALIDATION & QUALIFICATION

TABLE OF CONTENT
OBJECTIVE
SCOPE
RESPONSIBILITIES
MACHINE DESCRIPTION
FLUID BED DRYER
FLUID BED PROCESSOR
LOADING & UNLOADING OF MATERIAL
EQUIPMENT SUBASSEMBLIES & PARTS FACEBOOK

MAIN BODY
AIR INLET SHUT OFF VALVE
BLOWER INLET SHUT OFF VALVE
AIR PREPARATION UNIT
PRODUCT CONTAINER & TROLLEY
Like Page Contact Us
DEHUMIDIFIER & MIST ELIMINATOR
EXPLOSION FRAME & FLAP Be the first of your friends to like this
FILTER BAG SHAKING DEVICE
DUCTINGS
BLOWER ASSEMBLY
SEALING GASKETS
CONTROL PANEL & POWER PANEL
CONTROL SYSTEM, FIELD INSTRUMENTS ETC.
TECHNICAL SPECIFICATION
MATERIAL OF CONSTRUCTION
ENCLOSURES
Utilities Specification
SAFETY FEATURES
FAT PROCEDURE:
CHANGE CONTROL PROCEDURE
DESIGN QUALIFICATION REPORT
APPENDIX
FIND US ON GOOGLE PLUS
OBJECTIVE:
To design, engineer, and supply the Fluid Bed Processor and to provide assurance that the machine is
manufactured as per theURS and it complies with the Scope of Supply.
To prove that each operation proceeds as per the design qualification and the tolerances prescribed there
in the document, are the same at utmost transparency.
SCOPE:
The scope of this qualification document is limited to the Design Qualification of Fluid Bed Processor .
This qualification document is part of a validation activity for the Fluid Bed Processor.
 RESPONSIBILITIES:
CLIENT:
To Check and Approve the design qualification.
MANUFACTURER:
To design, engineer and provide the complete technical details of theequipment pertaining
to its design qualification viz.
Machine overview,
P&ID drawing,
Equipment orientation with layout, Pharmaceutical Guidance
Specifications of the sub-components/ bought out items, and their make, model & quantity, and Seguir
backup records/ brochures,
92 seguidores
Details of Utilities,
Identification of components for calibration
Material of construction of all components
Safety features and alarms
To facilitate the client for the Factory acceptance test of the machine attheir works/ site.
To confirm the safe delivery of the equipment to the user site.
To ensure that no un-authorized and or unrecorded design modifications shall take place. If at any
point in time, any change is desired in the mutually agreed design, Change control procedure shall
be followed and documented.
To ensure the proper installation and commissioning of the equipment.
MACHINE DESCRIPTION:
FLUID BED DRYER
The Principle of Fluid Bed Dryer is to create a fluidal turbulence in and a granulated or Powdery wet
product by means of hot air or dehumidified air flowing in an upward Direction & to dry the same to the
final required degree in a careful manner.
SUITABILITY:
In Fluid Bed Dryer the wet material is transposed to a fluidized state by hot air stream that surrounds the
material completely & therefore the heat Transfer rate achieved is very high & the temperature distribution
throughout the product is uniform. Due to this, drying time is considerablyReduced & therefore high
production rates are achieved in comparison toother dryers. As the product is in the close contact with
hot Air at lowtemperature & also for short duration, the physical & chemical propertiesof the product are
generally not affected & therefore the dryer caneffectively be used for the heat sensitive products. Due
to movement of
product during drying, lump formation, case hardening etc., isminimized.The Fluid Bed Dryers are not
suitable for drying of liquids orpasty material.
FLUID BED PROCESSOR
The principle of Fluid Bed Processor is to produce the uniform sized granules from the dry powder /
crystalline material by addition of binder material and spraying the liquid solution through top spray
atomizing nozzle, peristaltic spray pump etc. The liquid is transported to spray nozzle by peristaltic pump
and mixed with compressed air to spray trial runs to achieve the optimum results and fine quality
granules.
The success of processor also depends on good binder composition. The ingredients are PVP, KBO, CMC,
Starch, Gelatin, Sugar Methyl cellulose, ethyl cellulose, Lactose.
LOADING & UNLOADING OF MATERIAL
Material should be transferred to product bowl either manually ormechanically. Material unloading can
be done by tilting the bowl and by manual operation. The unloading may be done means of Pn. Conveying
system or mechanical tipper.
EQUIPMENT SUBASSEMBLIES & PARTS
MAIN BODY
M.O.C. S.S. 316 ,THICKNESS -3 mm
It is a Cylindrical Retarding Chamber & Filter Bag Housing, VerticalExplosion Chamber etc. supported on
slabs. A cylindrical bottom bodyresting on floor Level.
The Accessories of main body are:
1. Vertical Cylindrical Body
2. PC Bottom & Top Sealing Gaskets.
 3. Safety Device for PC.
4. L / S Glass Windows
5. Farthing Device
6. Air Inlet Nozzle
7. Blower Inlet Nozzle
8. Explosion Frame & Flap (Vertical)
9. Lifting Eyebolts & Lugs
10. Spray Window & Cover
11. Pneumatic Shaking Cylinder
12. Pneumatic Component for PC Sealing
13. Pneumatic component for bag sealing & shaking
14. Bottom Dish, Leg supports.
15. Bottom Drain Triclover union with blind cover
16. Charging Nozzle
17. CIP Nozzle & Manifold
18. Manholes
19. Support bracket frames
20. Explosion duct extension and canopy
AIR INLET SHUT OFF VALVE
M.O.C. S.S. 304 ,THICKNESS 35 mm
It is an isolating valve between main body and air preparation unit. The typeof valve is On/Off. The flap is
operated through a double acting pneumatic actuator. This remains close when the equipment is not in
use or during bagshaking.
BLOWER INLET SHUT OFF VALVE
M.O.C. S.S. 304 ,THICKNESS 35 mm
This valve is provided between the blower suction nozzle & main body. The type Of valve is On/Off. The
flap is operated through a double acting Pneumatic Actuator and this valve also remain close when the
equipment is not in use or during bag shaking.
AIR PREPARATION UNIT
M.O.C. S.S. 304,THICKNESS -3 mm
It is Rectangular Housing to accommodate Air Filters (20+5 Micron, 3Micron & 0.3Hepa) and air heater.
The one end is provided with filterMounting frame while other with a transition duct for changing
rectangular section to circular duct.
The Accessories Fitted are
1. Steam Inlet & Outlet Nozzle
2. Air Guide Cone
3. S. Air Heater
4. P Connection Ports
5. Access Door
6. Hot & Cold Air Damper.
7. Air Filter 20 + 5 Micron
8. Fine Filter 3 Micron
9. Hepa Filters 0.3 Micron
10. Hepa test window with cover
11. Hepa Filter fixing Frames
12. Temperature Sensor Socket
13. Lifting Lugs
PRODUCT CONTAINER & TROLLEY
1. PRODUCT CONTAINER
M.O.C. S.S. 316, THICKNESS 3 mm
This is a conical shaped container having the formed end at top and a welded flange at bottom. The wet
product is loaded in the container, as per its working capacity i.e. 250 kg.
Accessories fitted are:
1. Bottom perforated plate
2. Dutch Weave Mesh
3. L/S Glass window
4. Quick change Clamps
 5. Sampling Device
6. Support bars
7. Temperature Sensor
1. TROLLEY
M.O.C. S.S. 304 , SIZE 40 NB PIPE
This is a tubular structure to support the product container, providedWith Provided for S.S. 304
swivel castors and PU Wheels. There arefour nos. Guide wheel brackets easy locating with main body.
The
Product container can be transported from one place to other easily with the help of trolley.
DEHUMIDIFIER & MIST ELIMINATOR
M.O.C. S.S. 304 Tubes + Aluminium Fins
M.S. Water Box & Structural Support
The dehumidifier is provided at inlet side of FBD. This is being used to control the relative humidify of
process air by removal of excess moisture at the particular temperature.
This is rectangular in shape with end flanges for connection with air inlet ducting. The chilled water is
being circulated at a controlled flow rate through the finned tubes that condense the excess moisture
present in process air. This condensate is being drained automatically from bottom of dehumidifier
through a siphon tube.
The accessories fitted are.
1. Chilled water inlet & outlet nozzle
2. Temp. Sensor socket
3. RH sensor socket
4. Chilled water control valve
5. Auto-drain siphon tube
6. Lifting lugs
7. Structural support etc.
8. Mist Eliminator
EXPLOSION FRAME & FLAP:
M.O.C S.S. 304 or Aluminium,THICKNESS 32 G
The S.S. 304 or aluminium explosion flap comprising of 32 G. thick S.S. 304 foil sand witched between
S.S. Z frame + base frame & supported by a flat rubber gasket. This entire assembly is fitted on topside of
main body as safety device. It suddenly releases the excess pressure developed inside due to explosion &
prevents the equipment & building from damages. It recommended that there should not be any
obstruction in the vicinity of Explosion Flap up to a reasonable distance of about 3 meters or more. The
suitable extensions Ducts may be provided to suit site requirements.
FILTER BAG SHAKING DEVICE:
`M.O.C. S.S. 304
This is an automatic type bag shaking arrangement. When the bag Hanger & bag is connected through
telescopic cylinder (3 stage),the shaking frequency and interval is variable parameters, which can be set
through PLC controller. The bag Shaking is required to remove the adhered product particles on the bag
contact surface to improve its permeability and avoid choking of the bags.
The accessories provided are:
1. Filter bag sealing gasket
2. FBT housing ring
3. Multiple finger filter bag
4. Filter bag hooks
5. Filter bag hanger
6. Quick change coupling
7. Cylinder for shaking & lowering
DUCTINGS
M.O.C. S.S. 304 & M.S. THICKNESS 2 mm / 3 mm
The ducting are provided between air preparation unit, main body, product Container, blower inlet etc.
made out of S.S. 304, this ducting conveys the air through filters bags to the blower suction.Then the air
is exhausted through the blower outlet ducting made out of M.S. The size & length of ducting are
designed to suit the site requirements.
The duct flanges are provided with FGN rubber gasket and C.S. /S.S. bolt & nuts.
 a) BLOWER ASSEMBLY
M.O.C. M.S. THICHNESS 4 / 5 mm
The blower is provided in the system to create an induced draft to pass the heated and conditioned air
through wet product and create the fluidization state of material, which produces a uniformly dry product
in a reasonably less time period.
The accessories of this assembly are:
1. Dynamically balanced backward curved Aluminium Impeller
2. Blower Casing
3. Supporting Structure
4. Anti vibration pads
5. Blower suction nozzle
6. Air guide cone
7. Manually operated flow control damper
8. Blower Inlet Shut Off Valve on/off type.
9. Blower outlet extension duct
10. Electric motor directly coupled with impeller
11. Silencer
Direction of rotation of impeller is very critical & must be checked at the time of installation & trial run.
Airflow is controlled through pn. Operated blower inlet shut off valve. This valve is located in the blower
inlet duct and as near to main body as possible. The valve remains close during auto pneumatic shaking
and at the end of process.
1. b) SILENCER
M.O.C. M.S. THICHNESS 1.6 & 3 MM
The silencer is provided after the blower outlet damper & duct the sound level up to 90 95 dB.
The accessories / parts of silencer are:
1) Perforated shell 2) Jacket Shell
3) Sound absorbing material 4) End flanges
1. c) EXHAUST FILTER HOUSING
M.O.C. M.S. THICHNESS 3 mm
The exhaust filter housing will be normally installed between main body and the blower. This is provided
with 5-micron air filters to arrest the fine particles escaping to atmosphere and caters the requirement of
pollution control to some extent.
SEALING GASKETS
M.O.C. Food Grade Quality rubber Silicon / FGN Rubber
For sealing the product container top and bottom face, as well the filter bag bottom end,pneumatically
operated inflatable sealing tubes are used. The tubes are inflated by compressed air at an operating
pressure ranging of 1.8-to 2.2-kg/ cm. Low-pressure safety switches are provided for safety of products.
The accessories of the assembly are:
1. Inflatable sealing gaskets.
2. Pressure regulating valve with gauge.
3. Pressure switches etc.
4. Flow Control Valve.
CONTROL PANEL & POWER PANEL
M.O.C. Control Panel S.S. 304 THICKNESS 2 mm Thk.
M.O.C. Pneumatic Panel S.S. 304 THICKNESS 2 mm Thk.
M.O.C. Power Panel M.S. THICKNESS 1.6 mm Thk.
1. The S.S. 304 pneumatic control panel is integral with control panel & fitted with Pneumatic
instruments viz.
2. The SS 304 Control Panel is Top Pendent mounted type located suitably near equipment & fitted
with Electrical & pneumatic Instruments Viz.
1. Man machine Interface (MMI) or operator interface terminal of PLC (OIT)
2. Audio Signal Hooter, Emergency off Push Button
3. Push Buttons, Rotary Switches etc.
4. Printer for data recording with s.s. Trolley
5. Pressure gauges
6. Pressure regulating valves
 7. Pressure gauges.
An operator can control the equipment operation & process through these control panels.
1. The M.S. power panel is foot mounted Twin Cabinet self-supporting type, located away from the
production area consisting of:
1. PLC Controller
2. Analog Modules
3. Motor Contactors
4. MCBS
5. Ammeter
6. Voltmeter
7. Indication Lamps
8. P Transmitters
9. Cooling Fan & Air filters
10. Panel Door Switch
11. Connector terminals
12. Earth safety relay
13. Emergency Push Button
14. Solid Flow Monitor
15. Electrical
Due to high voltage switchgears, which are hazardous for flameproof areas, this panel is located away
from equipment. At the non-production area same time maintenance becomes easier due to its remote
location.
CONTROL SYSTEM, FIELD INSTRUMENTS.
The equipment is provided with control system & field instruments as list below.

Sr. No. PARTICULARS MAKE FUNCTION

01. Differential Pressure Gauge or Dwyer Monitor P Across Hepa

Transmitter filter
For Hepa Filter

02. Differential Pr. Gauge for exhaust Dwyer Monitor P Across

filters exhaust filters

03. Programmable Logic Controller Mitsubishi Programming of process

Logic

04. Variable Frequency Drive Mitsubishi To vary motor speed & air
flow control

05. Operator Interface Terminal Beijer Process Monitoring

06. Printer Epson Process Records

07. Temperature Sensor For Radix Temp. Measurement &

Inlet Air control
Outlet Air
Product Bed

08. RH Sensor & Transmitter E+E or Monitor & control air

Equivalent dehumidifier

09. Air Velocity Sensor E+E or Equiv Monitor & control air flow

10. Heating Control Valve (On/Off Samson Steam Flow Control

Type)

11. Chilled water control valve (On/Off Samson Chilled water diverting
Type)

12. Pr. Gauges and Regulators For PC Radix / Festo Air Pr. Regulation
Bottom,PCT Top & F.B.Tube
Gaskets

13. Pressure Gauge For Air Filter, Festo Air Pr. Regulation
Regulation Unit
Sr. No. PARTICULARS MAKE FUNCTION

14. Pneumatic Cylinder Aircon Operating bag shaking

15. Pneumatic Actuator El-O-Matic Operating Inlet Shut Off

Valves

16. Pneumatic Actuator With El-O-Matic For By Pass Damper

Positioner

17. Earth Relay & Sensor AEC Ensure Earth Contact Off
Product Container

18. Ammeter & Voltmeter Meco-G Measuring Current &

Voltage

19. Indication Lamps Teknic Ensure The Elec. Supply

20. Pneumatic Hand Valve & Solenoid Festo Operating Sealing Gasket
Valves

21. Safety Pressure Switch Festo/ For Sealing Gaskets

Switzer

22. Air Filters Pharmatek Air Filtration & Pollution

Control

23. Explosion Flap AEC Safety of equipment &

personnel

24. Silencer Alliance To reduce noise level of

blower

25. Solid Flow Monitor STECS To Detect Bag Damage

26. Condensate Drain Valve Aira Removal of condensate

from air Heater

27. CIP/ WIP Nozzle Siddarth / Washing main body

Equivalent

28. Peristaltic Spray pump Electro Lab Spraying solution

29. Spray Nozzle Schlick or Atomizing the spray

Equivalent solution

30. Flameproof Lamp Trimiti For better visualization in

R.C.

TECHNICAL SPECIFICATION

Description Specification

1. Pre-Filter

Filter Make Pharmatek

Micron rating / Material 5 + 20 Micron /(HDP /Dry Fabric)

Filter Size 24 X 24 X 12

Capacity 2000 CFM

Efficiency 60 65 % on ASHRE STD.

Grade 20 + 5 m

Total No. 04

2. HEPA-Filter

DOP Penetration 0.03 %

Filter Make Pharmatek

Micron rating / Material 0.3 micron/Micro glass Fiber

Filter Size 24 X 24 X 12

Capacity 1100 CFM

Description Specification

Efficiency 99.97%

Total No. 04

3. Filter bag

Filter Make Alliance

Micron rating / Material 5-10 micron / Anti static polyester cloth

No of Finger 37 finger

Air permeability 5 m3/m2/min at 10mm wc

4. Product container

Capacity Wet material-250 kg

Temp. Sensing Port To be Provided

Sample Port To be Provided

Silicon Gasket To be Provided

Dutch weave To be Provided

5. Expansion Chamber

Type Cylindrical

MOC SS 316

Qty. of Bull eye 03 nos.

MOC for Bull eye Toughened Glass

Explosion Valve To be provided

6. Spray Nozzle Window

Spray Nozzle window To be provided

Qty. 04 nos.

7. Material Charging Nozzle

Qty 01 No.

MOC SS 316

8. Blower Motor

Type Flame proof, 3 phase induction motor

Power rating 30 HP / 41510%V

/ 505% Hz

RPM 2955

Make Crompton Greaves

9. Air Inlet ON / off Valve

Air Inlet ON / off Valve To be provided

10. Pressure Cylinder for shaking

Type Telescopic, double acting

Size 100 mm , 700 mm Stroke x 3 Stage

End shaft SS 304

To be provided

Seals Nitrile rubber

11. PLC Controller

Model FX2N, 32 MR

Digital I/P 16 Input

Digital O/P 16 Output

Description Specification

Make Mitsubishi

12. Analog Input module

Make Mitsubishi

Model FXON, 3 A

Conversion Analog signal to digital signal

Quantity 4 Nos.

13. MMI

Type CEPL / M52A

Serial port RS 422

Serial port RS 232

Display Touch screen

Supply voltage 24 VDC

14. Printer

Type LX300+ Dot matrix printer

Model P170A

Make Epson

15. Variable frequency drive

Type FRA540-18.5K

Model FRA 500

Make Mitsuibishi

16. Pressure Gauge for Steam inlet

Make Radix

Least Count 0.2 kg / cm2

Range 0 10 kg/cm2

Mounting Bottom entry male type

17. Pressure Gauge Steam Solenoid Valve PRV

Make Radix

Range 0 4.2 kg/ cm2

Least Count 0.1 kg / cm2

18. Pressure Gauge for I/ P Converter

Make Radix

Range 0 4.2 kg/ cm2

Least Count 0.1 kg / cm2

19. Pressure Gauge for PC PRV

Make Radix

Range 0 4.2 kg/ cm2

Least Count 0.1 kg / cm2

20. Pressure Gauge for filter bag PRV

Make Radix

Range 0 4.2 kg/ cm2

Least Count 0.1 kg / cm2

21. Pressure Gauge for filter bag sealing tube

Make Radix
Description Specification

Range 0 4.2 kg / cm2

Least count 0.1 kg / cm2

Location Control Panel

22. Pressure gauge for PC sealing

Make Radix

Range 0 4.2 kg / cm2

Least count 0.1 kg / cm2

Location Control Panel

23. Air Velocity Sensor

Manufacturer E+E Electronics

Specification EE 70 VT XX

Power Rating 24 VDC 20 %

Flow Rate Range 0 20 [m/s]

24. Temperature Sensor for Inlet air

Manufacturer Radix

Model PT 100 3 wire

Insert Length 12

Temperature Range 0 250 oC

25. Pressure Gauge (Chilled water inlet)

Make Waaree

Range 0 16 kg / cm2

Least Count 0.2 kg / cm2

26. Pressure Gauge (Chilled water outlet)

Make Waaree

Range 0 16 kg / cm2

Least Count 0.2 kg / cm2

27. Temperature Sensor for Outlet air

Manufacturer RADIX

Model PT 100 3 wire

Insert Length 8

Temperature Range 0 250 oC

28. Temperature Sensor for Product bed

Manufacturer RADIX

Model PT 100 3 wire

Insert Length 6

Temperature Range 0 250 oC

29. Differential Pressure transmitter across HEPA filters

Manufacturer Dwyer Instruments

Model 616C-2

Input Range 0 6 WC

30. Differential Pressure transmitter across Product Filter bag

Manufacturer Dwyer Instruments

Model 616C-5
Description Specification

Input Range 0 -40 WC

Max. Pressure 15 PSIG

31. Police Filter

Capacity 60 65 %

Size (24 X 24 X 12 ) mm

Micron Rating 5m

Make Pharmatek

32. I to P Converter

Make Watson smith

Type 100 X

Input 4-20mA

Output pressure 0.2 1 bar

Inlet pressure 5.5 bar

33. Solid Flow Monitor

Make STECS

Size 300 mm long sensor

34. Earth Safety relay

Make Alliance

Input supply 220 VAC / 50 Hz / 5 A

Output Potential free contacts

Input Earth contact

35. Sealing gaskets for Product container (top& bottom) and Filter bag

Type Inflatable tubes

MOC Non toxic Food grade silicone rubber/

Neoprene + PLC (White)

36. Pneumatic Actuator for Drain Pump

Make AIRA

Size 40 mm

Valve Ball type

Rating 150

Operating Pressure 80 PSI

37. Pressure Actuator with Positioner for Air inlet

Make EL-O- Matic

Type PD-150

Input range 4 to 20 mA

Output range 3-15 PSI

38. Pressure Actuator with Positioner for Bypass damper

Make EL-O- Matic

Type PD-60

39. Pressure Actualator with positioner for outlet air

Make EL O Matic

Type PD 150

40. Rotary valve positioner

Description Specification

Make EL O Matic

Model LC

Range 0 900

41. Emergency Switch Off

Qty. 02 Nos.

Position PLC/control Panel

42. Product container sensor

Make Radix

43. Pressure Gauge for rotary valve positoner closing

Make Wika

Range 0 10 kg / cm2

Least count 0.5 kg / cm2

44. Pressure Gauge for rotary valve positoner opening

Make Wika

Range 0 10 kg / cm2

Least count 0.5 kg / cm2

45. RH sensor cum transmitter

Make Rotronic

Power 10 35 VDC

Range 0 100 % RH

46. Lamp

Make Trimiti

Type Flange proof / Water proof

Rating 100 W

47. Dehumidifier

47.1 Chilling Coil

Make Alliance

Heat transfer area 238 Sq meter

MOC
a) Tube SS 304
b) Fin Aluminium

inlet/ Outlet temp. C 7-8C / 12-13C

Air flow rate 8000 m3/ hr

47.2 Steam Air Heater

Type Finned tube

Make Virtex

MOC SS + SS 304

Heat Transfer Area 80 m2

MATERIAL OF CONSTRUCTION

Description Specification

Product Container SS 316

Dutch weave Mesh SS 316

Description Specification

Product Container SS 316

Dutch weave Mesh SS 316

Retarding chamber SS 316

Explosion chamber SS 316

Filter bag tube ring SS 316

Filter bag hanger SS 316

Charging nozzle SS 316

Trolley SS 304

Air inlet duct SS 304

ENCLOSURES:

Sr. No. Description Drawing No.

1 General arrangement drawing of

Fluid bed Processor

Utilities Specification

Description Specified

Electrical Connection To be provided

Compressed Air Connection To be provided

Steam connection to the heating coil To be provided

Chilled water for dehumidifier To be provided

SAFETY FEATURES
The equipment shall be provided with safety features as listed below.

Sr. NO. FEATURE SPECIFIED

01. Slab Mounted Equipment For cGMP Site Layout

02. Motor Overload Relay, If Overload The Switch Gear For Motor Safety
Trip

03. Earth Safety Relay, If Improper Earthing Halts The For Equipment &
Process Operator Safety

04. Emergency Off, If Activated Stops The Process For Equipment &
Operator Safety

05. Pressure Switches For For Product Safety &

1) P.C. Sealing Gasket Gasket Safety

2) F.B. Tube Gasket

If Air Pressure Lower Than Required Then Stops The
Process

06. Temp. Sensors Air Inlet, If Inlet Temp. Increases Than For Product Safety
Set Value, The Steam Control Valve Closes.

07. Password Protection To Operate PLC, Recipe For Product Safety &
Features Via Operator Interface Terminal Batch Integrity

08. Explosion Flap, If Released Relieves The Excess For Plant Building,
Pressure Developed During Explosion Equipment& Human
Safety

09. Safety Clamps (Manual) For Holding Product For Equipment & Product
Container & Acting As A Jumper For Earth Continuity Safety
Of PC & RC

10. Solid Flow Monitor, If activated stops blower For Preventing Product
Loss
 11. RH Sensor, if the RH value exceeds the set point then For product quality
cold water flow gets diverted consistency

FAT PROCEDURE:
Factory Acceptance Test Procedure shall be as follows:
After the completion of erection work of the machine, client shall be informed to perform the factory
acceptance test (FAT).
Client shall perform the FAT at the manufacturer site and record all the data in the prescribed FAT
document as per the details given below:
1. Test criteria
2. Design Verification Check list
3. Deficiency & Corrective Action report
4. Pre-installation requirements
5. Final report
CHANGE CONTROL PROCEDURE:
Change in the agreed design shall be addressed through the well-defined Change control procedure.
DESIGN QUALIFICATION REPORT
APPENDIX
Abbreviations and Definitions reference Document

SR.NO. ABBREVIATIONS PARTICULARS

01. PG Differential Pressure Gauge

02. A Ammeter

03. AI Analog Input

04. AO Analog Output

05. AFS Air Flow Sensor

06. ASS Ammeter Selector Switch

07. AISOV Air Inlet Shut Off Valve

08. BISOV Blower Inlet Shut Off Valve

09. C Contactor

10. CF Cooling Fan

11. CGMP Current Good Manufacturing Practice

12. CT Current Transformer

13. CDV Condensate Drain Valve

14. DI Digital Input

15. DO Digital Output

16. DS Panel Door Switch

17. DH Dehumidifier

18. EPB Emergency Push Button

19. ER Earth Relay

20. ES / ED Earth Senor / Earthing Device

21. F Fuse

22. FB Filter Bag

23. FBD / FBP Fluid Bed Dryer / Fluid Bed Processor

24. For Pn. Fitting and Accessories Pn. Accessories, Ref. Pn. Data list & Circuit

25. FBT Filter Bag Tube

26. FCD Flow Control Damper

27. H Hooter

28. HCV Heating Control Valve

29. HMI or MMI Man Machine Interface

SR.NO. ABBREVIATIONS PARTICULARS

30. HTW Hepa Test Window

31. HP Horse Power

32. HV Hand valve

33. I/P I to P Convertor

34. LR Pressure Regulating Valve

35. M Motor

36. M 1 Proportional Pn. Actuator

37. MCB Miniature Circuit Breaker

38. ME MIST. Eliminator

39. MOC Material of Construction

40. OIT Operator Interface Terminal

41. O/L Overload Relay

42. PB Push Button

43. PC Product Container

44. PID Proportional (P), integral (I), Derivative (D)

45. PCB Product Container Bottom

46. PCT Product Container Top

47. PG Pressure Gauge

48. PLC Programmable Logic Controller

49. PO Purchase Order

50. PS Pressure Switch

51. RH Relative Humidity

52. RPM Rotations Per Minute

53. RS Rotary Selector Actuator

54. S Solenoid Valve

55. SS Stainless Steel

56. SFM Solid Flow Monitor

57. TR Temp. Transmitter

58. TC & B Triclover & Blind

59. V Voltmeter

60. VSS Voltmeter Selector Switch

61. VFD Variable Frequency Drive

Sharing

Confocal Microscope
Capturing cell images quickly, easily, and not in the darkroom!

ABOUT AUTHOR

PHARMACEUTICAL GUIDANACE
 RELATED POSTS

SEPTEMBER 3, 2016 1 AUGUST 22, 2016 0 AUGUST 21, 2016 2

Performance Qualification DESIGN QUALIFICATION OF BIN DESIGN QUALIFICATION

Protocol of Tunnel Sterilizer WASHING & DRYING SYSTEM CARTONING MACHINE HI CART
(BLISTER PACKING)

1 COMMENT

SUSHESH SAINI on AUGUST 20, 2016 11:51 AM

Your design qualification topic right way

REPLY

LEAVE A REPLY

Your Comment

Your Name

Your Email

Your Website

POST COMMENT

GO BACK

ABOUT RECENT POST SHARING

Pharmaceutical Guidance Performance Qualification Protocol of Tunnel Sterilizer

SOP on Quality Risk Management

Pharma Guidance is Indias online complete Pharma
solution platform, where people can connect with each
other to share knowledge, buy the required Pharma
related Document .The vision is to support the all
manufacturers of pharmaceutical company to prepared
the current and update document to complies the cGMP
norms and also give the updated knowledge to new
Pharma beginner.

Copyright 2016 - Pharmaceutical Guidance by Sainssoft Technology