FREEZE DRYING

SOLUTIONS
AND LOADING/UNLOADING SYSTEMS

Freeze Drying Solutions

THE BEST IN FREEZE DRYING TECHNOLOGY
SOLUTIONS, PRODUCTS AND SERVICES
LYOMAX
LYOFAST
MINIFAST
LOADING SYSTEMS
IMA LIFE INNOVATION
IMA LIFE SERVICES

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THE BEST IN FREEZE DRYING TECHNOLOGY

IN ASEPTIC CAPPING

THE BEST IN FREEZE DRYING

TECHNOLOGY, HANDINHAND
WITH THE WORLDS LEADING NAME
IN ONE STOP ASEPTIC PROCESSING
AND FILLING SOLUTIONS FOR THE
PHARMACEUTICAL AND BIOTECH
INDUSTRY.

HISTORICAL NOTES
IMA LIFE has been supplying pharmaceutical process equipment
for more than 50 years, but its origins arise from when the Edwards
Vacuum company was founded in the UK at the beginning of the
20th century. Having initially focused solely on vacuum equipment,
Edwards broadened its product portfolio with the major step
of entering the pharmaceutical freeze drying sector in the early
1950s.
This freeze drying business evolved from the UK into a production
facility in Italy, and having been acquired by BOC Group in 1968, it
further expanded in the 1980s with a production site in Germany.
As the pharmaceutical market grew in the US so did Edwards
freeze drying business by establishing IMA LIFE current facility in
Tonawanda, NY in 1989. Moving to 1995, the Dongen facility in The
Netherlands was acquired, bringing with it considerable expertise
in vial handling which has spurred Edwards existing leadership
position in automated loading and unloading systems.
Today the Edwards freeze drying business stands as integral part
of the IMA LIFE division, making it widely recognised as the world
leader in freeze drying solutions.

For more than half a century, IMA LIFE has provided the benchmark
for freeze drying solutions to the pharmaceutical and biotech
industry. We have a truly global presence with our main facilities
well positioned to serve customers in all corners of the world. With
over 1000 freeze dryers installed in over 50 dierent countries, we
are ready to leverage this experience to better serve your needs.
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SOLUTIONS PRODUCTS AND SERVICES

We strive to make our name synonymous with best-in-class solutions across the complete
spectrum of our scope of supply: from research, development and design, into freeze drying and
automated loading, onto project management, full turn-key systems integration, and on-going
services. We want to be your partner of choice through the complete life cycle of your freeze
drying systems.

WE ARE THE GLOBAL FREEZE DRYING SOLUTIONS

PARTNER OF CHOICE.
BUILDING ON DECADES OF VALUED RELATIONSHIPS,
WE WORK WITH OUR CUSTOMERS IN THE CONTINUOUS
PURSUIT OF OPERATING EXCELLENCE TO PROVIDE
BESTINCLASS SOLUTIONS THROUGHOUT
THE PRODUCT LIFE CYCLE.

LYOMAX

LYOFAST

LYOFAST MINI

The most comprehensive range of custombuilt freeze dryers for those who require
more than a standard solution.

The most versatile standard lyophiliser is

available as a stand-alone unit, or as part
of a complete integrated pharmaceutical
packaging system.

The ideal solution for pilot work or clinical

trials production. Its compact footprint
allows also for product development and
process cycle optimisation.

MINIFAST

LOADING SYSTEMS

The connecting factor between a typical

bench-top freeze dryer used in laboratories
and the industrial range of freeze dryers.

The automatic loading and unloading systems are designed to continuously transfer vials from the
liquid lling equipment to the freeze dryer and from the freeze dryer to the alu-capper, maintaining
the level of protection around the products.

LYOMAX

The legendary reliability and performance of IMA LIFE is epitomised by the Lyomax freeze drying
range. Lyomax oers the most comprehensive range of custom-built freeze dryers for those who
require more than a standard solution. Lyomax can provide the solution from 1m to 100m applying
state of the art engineering in vacuum, refrigeration, stoppering and heat transfer technology.

CREATED FOR CONFIGURETOORDER APPLICATIONS

USING MODULAR DESIGN TECHNOLOGY, LYOMAX CAN
BE DESIGNED, MANUFACTURED AND QUALIFIED TO MEET
ANY REQUIREMENT. WITH LYOMAX, VIRTUALLY ANY
CONFIGURATION IS POSSIBLE, WHETHER SINGLE FLOOR,
MULTILEVEL OR PASSTHROUGH.

BUILDING ON SUCCESS
Lyomax has been the solution of choice for
the leading pharmaceutical and biotech
companies for over 50 years.
There are now in excess of 1000 Lyomax
installations, many integrated with both
automated loading systems and isolators,
supporting our customers across the globe in
over 50 countries. Lyomax is a global solution
meeting the diering local requirements of
all our customers. This history of partnership
with our global customers and listening to
their needs has allowed Lyomax to remain
the leader in freeze dryer development.

INTELLIGENT ENGINEERING
IMA LIFEs employees bring over 3000 man years of pharmaceutical design and manufacturing
experience to providing best-in-class solutions for all your freeze drying needs. In order to gain
control of development time and cost in custom engineering, we use the Modular Design
Technology (MDT), which allows for the well-balanced use of pre-engineered modules wherever
possible. The Lyomax range is equipped with the latest SCADA system, managing a robust series of
PLCs to cover global requirements. The machines are all qualied in accordance with GAMP4 and
comply with the latest FDA and EMEA requirements.
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APPLICATION DEMANDS

REDUCED CAPITAL
AND OPERATING COSTS
The benets of a modular approach and IMA LIFE unique position
as a global manufacturer with a streamlined supply chain, allows
us to pass on capital cost savings to you, the customer. This is
supplemented by our continuing initiatives to reduce customer
operating costs by introducing superior solutions to the market
such as our Fusion solution for product shelves.

Compact, monobloc design

using Lyomax configuration

Two-storey configurations

Pass-through configurations

Multi-skid configurations

Bulk, vial, ampoule and syringe

applications

Integrated systems with automated,

semi-automated and manual loading
and unloading equipment

Constructed from proven sub assemblies

to combine flexibility of design
and layout with efficient manufacture,
ease of shipment and installation.
The design of the system provides good
accessibility for cleaning
and maintenance and facilitates
working to cGMP standards.

COMPREHENSIVE DOCUMENTATION,
SWIFT VALIDATION
Our internal Quality Management system has, for many years, been
accredited with ISO9001-2000. This system provides integrated,
comprehensive documentation relating to the manufacture of
all products, ensuring the user is provided with full details of the
equipment. In order to assist in swift and painless equipment
validation, we can also provide a standardized IQ and OQ
documentation package.

PROCESS ENVIRONMENT
Fusion solution for product shelves enhances process
performance and reduces operating cost and business risk
Our patented Fusion Plus technology eliminates the risk of vial
stoppers sticking to shelves and disrupting the automated
unloading process
We are leading the way in development of a reliable, industrial
solution for wireless product temperature monitoring
Lyomax designs allow for ease of integration with isolators
and cRABs.
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LYOMAX PRODUCT SOLUTIONS & TECHNICAL FEATURES

PRODUCT SAFETY BY DESIGN

IMA LIFE place high emphasis on product

safety. For this reason key components of the
system are duplicated

The shelf temperature control system, which

has a double pumping system, one pump being
sufficient for operation

The condenser has over-capacity for ice,

allowing performance of multiple cycles
between condenser defrosts or completion of
cycles in event of failure of a refrigeration
compressor when there are multiple
condenser compressors

The control system has a wide range of

features to protect in case of malfunction or
operator error

The refrigeration systems are independent and

will serve both shelves and condenser. Routine
or extraordinary compressor maintenance
may be performed during a cycle using the
other compressors to maintain the cycle if
redundant compressors are included

The chamber and condenser are designed

in accordance with the appropriate vessel
construction code and good vacuum
construction practices

Numerous safety interlocks to safeguard

product/operator

Lyomax is a proven solution for solvent,

potent compound and ATEX applications.

IMA LIFE LEGENDARY RELIABILITY AND

PERFORMANCE ARE EPITOMISED BY
THE LYOMAX FREEZE DRYING RANGE...
THE BENCHMARK ENGINEERED
SOLUTION.

FULLY AUTOMATED CONTROL

The control and recording of the lyophilisation process is a
critical factor in ensuring a high level of Quality assurance:

eLyomaster modular control system based on industry

standard iFix SCADA

Multiple PLC platforms supported (Siemens, Allen-Bradley,

Modicon, Mitsubishi)

DCS control architecture (eg Delta V) supported

Historical trending

Configurable batch reports

CFR part compliance

Dual element temperature probes

Paperless chart recorders

Equipment may be manually controlled via the control

system (for safety reasons the SIP cycle is excluded)

Flexible configuration to enable complex process cycles

Comprehensive GUI simplifies programming

Full programming documentation, source code and ladder

logic, provided for ease of validation.

CLEAN AND STERILE

Lyomax
lyophilisers
comply
with
international cGMP guidelines regarding
cleanliness and sterility for aseptic processing.
Equipment features:
AISI 316L for machines with SIP for
product contact parts with a surface
roughness of 0.25 - 0.4 RA
Designed for sterilisation with saturated
steam at 127C
Free draining surfaces

Corners with generous radii to ease

cleaning
Compatibility with common sterilizing/
sanitizing chemicals
Innovative design for ease of cleaning of
back of slot door
SIP measurement/control based on the
equipment cold spot
CIP skids and recirculation systems
available

Rotating and/or xed CIP spray nozzles

Hydrophobic lter with lter integrity
testing (WIThin)
Water ring pump to remove residual water
post-sterilisation
Flexible bellows to enclose the hydraulic
piston in chamber
Pressure plate and counter pressure plate
provided in lattice design for ease of
cleaning.

Easy access for cleaning

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LYOMAX PRODUCT SOLUTIONS & TECHNICAL FEATURES

INTELLIGENT DESIGN
Lyomax lyophilisers are designed and tested to meet all your
performance requirements:

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Shelves designed and manufactured

using our patented fusionTM technology

Shelf planarity of .mm/m

Chloride-free insulation

Chambers clad in aluminium or stainless steel

Chamber jacket cooling utilising water or silicon oil

Fully automated door locking system

Orbitally welded sterile pipework

Documented boroscopic inspection of all orbital welds

Full penetration TIG welds avoid difficult to clean crevices

and potential leakage paths

SYSTEM INTEGRATION
20 years experience successfully
integrating Lyomax with xed and exible
automated loading and unloading systems
in aseptic applications

Pipework connections are kept short to ease cleaning

Constant level loading

Strength in depth on project management

of integration projects

Variable stoppering pressure control

SCADA systems designed for integrated

systems

Fusion Plus solution to avoid vial stoppers sticking

Design, documentation and test built

from an integrated foundation

Removeable condenser heads available

Slot door and shelf interface designed for compact

and smooth loading system integration

Industry approved designs for solvent

and potent compound applications

Designs that meet the challenge of ATEX requirements.

ROBUST VACUUM SYSTEMS

HIGH PERFORMANCE REFRIGERATION

The vacuum system of a lyophiliser provides

the necessary pressure environment for the
lyophilisation process to occur:

Lyophilisation requires low temperatures and the demands of biologicals are driving the need
for increasingly lower temperatures. IMA LIFE refrigeration expertise has enabled reliable high
performance to be achieved:

Use of sanitary connections and avoidance

of threaded connections

Reciprocating compressors, screw compressors or cryogenic (LN2) solutions

Two stage, oil sealed rotary pumps

Roots/rotary combinations
Dry pump technology
Capacitance manometer technology
Modulating vacuum control with
capacitance manometer
Controlled leak of air from the process
area
AISI 316L vacuum pipework.

Canned pumps and magnetic drive uid circulation pumps

Use of highest quality components
Minimised use of threaded connections
Stainless steel lines used on lines under high working stress
Electronic expansion valves available to optimise the operation of the refrigeration system
Ultra low viscosity, non-ammable Safetherm HX heat transfer uid to improve transfer
properties and reduce risk
Direct expansion or heat transfer uid cooling of condenser
Use of environmentally acceptable refrigerant gases
High eciency stainless steel plate heat exchangers.

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LYOFAST

With the Lyofast range of freeze dryers, IMA LIFE quality is within everyones reach. Until recently
the development of high-end pharmaceutical lyophilisation equipment meant custom engineering
with the associated costs and lead-time. However, in recent years Lyofast has broken the mould
and rapidly achieved signicant global presence with installations in over 25countries, including
many of the worlds leading pharmaceutical manufacturers.
The Lyofast concept extends the IMA LIFE range providing support for all your freeze-drying
requirements. Lyofast guarantees superior quality, reduced lead-times, lower costs and simplies
the validation process.
The specications of the base model meet all leading industry standards and the broad range of
standard options enable Lyofast freeze dryers to be tuned to your specic requirements. For decades,
IMA LIFE has been synonymous with quality, high technology pharmaceutical equipment.

ALL IMA LIFE EXPERIENCE

IN MANUFACTURING AND
SUPPORTING LYOPHILISERS
COMES TOGETHER IN
LYOFAST; THE BENCHMARK
VALUE SOLUTION.
UNCOMPROMISED QUALITY
AT A COMPETITIVE PRICE.

VERSATILE FOUNDATION
A series of standard modules provides the foundation of the Lyofast model concept. Preengineering results in time and cost benets, while a wide range of standard options ensures
sucient exibility to cover a broad range of congurations. Lyofast is the most versatile standard
lyophiliser available.
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REDUCED LEADTIMES

GLOBAL CONTINUITY

By constructing from a series of standard modules, IMA LIFE is able to compress project schedules
and reduce lead-times even with large capacity equipment. Compared to a custom-built lyophiliser,
the lead-time for Lyofast is reduced by up to 50%.This provides users with a competitive edge by
reducing time to market.

Lyofast is one of IMA LIFE s many Freeze

Drying Solutions. Our extensive product
portfolio backed by worldwide sales,
service and technology centres enables
customers with global operations to
leverage the benets of continuity across
their sites.

REDUCED CAPITAL COST

The benets of our modular standardised approach, combined with our streamlined supply chain,
enable cost savings to be passed on to you, the customer.

ENHANCED SALES SUPPORT

The standardisation of Lyofast simplies and enhances sales support. IMA LIFE puts
great importance on providing sales and applications personnel who have an in-depth
understanding of pharmaceutical processing. Instead of simply selling individual pieces
of equipment, the aim is to provide integrated, validated solutions. This is demonstrated by
IMA LIFE laboratory facilities, supporting customers freeze-drying cycle development requirements
and liquid and powder lling evaluation. In recent years, IMA LIFE has promoted preferred supplier
agreements with key customers around the world. This has enabled IMA LIFE to better understand
customers cost of ownership issues in order to work together to reduce costs.

LYOFAST, NOW AND

TOMORROW
At IMA LIFE, continuous product
development provides the foundation
for future growth, including an advanced
program that challenges traditional
technologies and processes and helps dene
the direction for future aseptic packaging.
This commitment to technology leadership
ensures that Lyofast will continue to provide
class-leading features.

COMPREHENSIVE DOCUMENTATION,
SWIFT VALIDATION
IMA LIFE internal Quality Management system has, for many years, been accredited
with ISO9001-2000. This system provides integrated, comprehensive documentation
relating to the manufacture of all products, ensuring the user is provided with full
details of the equipment. In order to assist in swift and painless equipment validation,
IMA LIFE can also provide a standardised IQ and OQ documentation package.

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LYOFAST PRODUCT SOLUTIONS & TECHNICAL FE ATURES

PRODUCT SAFETY BY DESIGN

IMA LIFE places high emphasis on product safety. For this

reason key components of the system are duplicated

The chamber and condenser are designed in accordance with

the appropriate vessel construction code and good vacuum
construction practices

Numerous safety interlocks to safeguard product/operator.

CLEAN AND STERILE

Lyofast lyophilisers comply with international cGMP guidelines
regarding cleanliness and sterility:

AISI L for machines with SIP and CIP with a surface

roughness of < .m for product contact parts

Easy access for cleaning

Free draining surfaces

Compatibility with common sterilising & sanitising chemicals.

Lyofast machines may be specified with Clean in Place (CIP) and

Sterilisation in Place (SIP) functions. These systems operate
automatically and provide a high level of assurance for the
cleanliness and sterility of the equipment.

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CLEAN IN PLACE CIP

316L stainless steel vessels
High pressure washing of internal surfaces of chamber and
condenser
High ow rates
Optional water recirculation system
Self-draining manifolds with wide angle spray nozzles
Rotating and/or xed spray nozzles
All clean-piping orbitally welded and inspected via boroscope

STERILISATION IN PLACE SIP

316L stainless steel vessels
Sterilisation with dry, saturated steam at >121C
Control and measurement based on equipment cold spot
Automatic door locking system
Optional hydrophobic lter(s) with lter integrity test
connections or embedded integrity testing (WIThin)*
Additional insulation of the vessels to retain heat
Water ring pump for removal of residual water after sterilisation
Optional water or silicon oil chamber jacket for rapid cooling of
the chamber and door after sterilisation
*WIThin is licensed from Sartorius

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LYOFAST PRODUCT SOLUTIONS & TECHNICAL FE ATURES

ROBUST VACUUM SYSTEMS
The vacuum system of a lyophiliser provides
the necessary pressure environment for the
lyophilisation process to occur. Comprised of
vacuum pumps, valves, instrumentation and
seals suitable for operating at high levels of
vacuum:

Two stage, oil sealed, rotary pumps as

standard

Roots/rotary combination are available

as an option

Optionally Dry vacuum pumps to

provide absolute security against
potential contamination of the product
by oil backstreaming, can be provided

Twin active Pirani gauges supplied for

measuring process and pump vacuum

Capacitance manometer gauges available

as an option for high accuracy vacuum
measurement

Modulating vacuum control

Controlled leak of air from the process

area

Manometer.

ADVANCED HEAT EXCHANGE

A heat exchange uid is used to transfer energy between the shelves
and the refrigeration and heating systems. Low viscosity oil is circulated
through heat exchangers to adjust the oil to the desired temperature
before being circulated through the shelves of the lyophiliser:
Closed loop system operating at atmospheric pressure
High eciency stainless steel plate heat exchangers used for
cooling of shelf recirculation uid
Electric shell heater with stainless steel heating elements
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HIGH PERFORMANCE REFRIGERATION

The lyophilisation process requires low
temperatures to be maintained for long
periods, placing considerable strain on the
refrigeration system. IMA LIFE refrigeration
expertise has enabled reliable high performance
to be achieved:

Ultra low viscosity silicon oil used as heat exchange medium

Stainless steel fully welded pipe-work throughout
Twin pumps for circulating the silicon oil provide security in the
case of pump problems (single pumps for Lyofast 1 and 25 and
above)

Use of the highest quality components

available worldwide

Standard systems employ double

stage, semi-hermetic, reciprocating
compressors

Generous system capacity ensures

performance can be easily achieved

Modular systems provide back-up

should problems arise

Sub-cooling systems maintain optimum

compressor operating temperature

Pressure sensors provide protection

in the event of abnormal operating
temperatures and pressures

Use of environmentally acceptable

refrigerant gases

Special synthetic oils used for

compressor lubrication to eliminate
problems encountered with mineral oils
at extreme temperatures

Systems constructed to ensure ease

of maintenance.

System fully insulated with closed cell moisture resistant foam.

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LYOFAST
IMA LIFE BESTINCLASS IS EPITOMISED BY THE LYOFAST FREEZE
DRYING RANGE
THE BENCHMARK VALUE SOLUTION.

FULLY AUTOMATED
CONTROL
The control and recording of the
lyophilisation process is a critical factor in
ensuring a high level of Quality Assurance.
Lyofast freeze dryers are supplied with a fully
automated control system.
Programmable logic controller (PLC)
based system
Windows operating system
Comprehensive graphical user interface to
simplify programming
Flexible conguration enables complex
process cycles
Generous storage capacity for dierent
program cycles and historical data storage
Operation protected by graduated
password levels

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INTELLIGENT DESIGN
Lyofast is fully tested according to standardised procedures in order
to demonstrate that the performance meets specied requirements.
All tests are documented and form the basis of the documentation
provided with all equipment.
Standard AISI 316L (an option for non-SIP and non-CIP
machines) stainless steel used for chamber, shelves and
condenser
Full penetration TIG welding avoids dicult to clean crevices
and paths of potential leakage
Documented X-ray weld inspection in accordance with
construction codes
Standard internal surface nish of <0.4m with mirror
appearance
Satin surfaced shelves to enhance heat transfer
Surfaces pitched to enhance drainage
Corners with generous radii to ease cleaning
Internal structures designed to ensure drainage and accessibility
for cleaning
Pipe-work connections are kept short to ease cleaning
Orbitally welded sterile pipe-work
Condensers provide generous capacity

Comprehensive interlocks to prevent misoperation

Equipment may be manually operated via the control system
Source code and ladder logic available
A printer is supplied for process information output
A range of chart recorder options are available, from 12 to 30
points for monitoring equipment temperatures and pressures,
as well as product temperatures.
Screw compressors may be substituted for reciprocating types.
Screw compressors provide greater eciency and reliability
whilst requiring less maintenance
Electronic expansion valves are available as an option to optimize
the operation of the refrigeration system.

Shelves are designed and manufactured using IMA LIFE patented

FusionTM solution. FusionTM technology enhances freeze dryer
performance and reduces operating costs by providing a lighter,
atter, stronger shelf than conventional freeze dryer shelves. The
FusionTM manufacturing process is highly automated ensuring
repeatability of manufacture to reduce risk and increase reliability
for your process.
Lyofast is congured to ensure a space ecient layout with adequate
access to facilitate maintenance. Typical congurations include:
Rectangular and cylindrical chambers
Horizontal and vertical ice condensers
Integral ice condensers
Monoblock arrangements for optimum space eciency
Split arrangements that enable the ancillary components to be
located remote from the chamber and condenser.

Further details are provided in separate specication sheets available from your
local sales oce.

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MINIFAST

The product is available in Minifast 04 and

Minifast 10 congurations, with shelf areas of
0.4 m and 1.1 m respectively. Ice condenser
capacities range from 8kg to 20 kg with
minimum condenser temperatures of -85C
as standard.
Product shelves are designed and
manufactured using the IMA LIFE patented
Fusion solution to enhance performance,
reduce operating costs and increase
reliability.

THE MINIFAST RANGE OF LYOPHILISERS PROVIDES THE

CONNECTING FACTOR BETWEEN A TYPICAL BENCHTOP
FREEZE DRYER USED IN THE LABORATORIES AND THE
INDUSTRIAL LYOFAST OR LYOMAX RANGE OF FREEZE
DRYERS. THE MINIFAST PROVIDES A DIRECT LINE OF SIGHT
AS REQUIRED BY THE FDA, BETWEEN THE PILOT TYPE FREEZE
DRYER WHICH IS SUITABLE FOR SCALEUP AND THE LARGER
FULL PRODUCTION FREEZE DRYERS. THE MINIFAST RANGE IS
THE IDEAL SOLUTION FOR PRODUCT DEVELOPMENT AND
PROCESS CYCLE OPTIMISATION.
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PEAK PERFORMANCE IN PILOT SCALE FREEZE DRYERS.

IMA LIFE MINIFAST RANGE
PROVIDES THE CONNECTION
BETWEEN LABORATORY DEVELOPMENT
AND INDUSTRIALISED PRODUCTION.

The standard shelf inter-distance is 80mm

with larger spacing oered as an option
(120mm on Minifast 04 and 160mm on
Minifast 10).
The Minifast is part of IMA LIFEs wider
oering of lyophilisation and aseptic
packaging equipment.
The current line-up includes the standard
Lyofast range of pre-engineered lyophilisers,
the high-end Lyomax range and fully
automated loading/unloading systems for
single and multiple freeze-dryer installations.

COMPREHENSIVE DOCUMENTATION, SWIFT VALIDATION

IMA LIFE internal Quality Management system has, for many years, been accredited
with ISO9001-2000. This system provides integrated, comprehensive documentation
relating to the manufacture of all products, ensuring the user is provided with full details
of the equipment. In order to assist in swift and painless equipment validation, IMA LIFE can also
provide a standardized IQ and OQ documentation package.

GLOBAL CONTINUITY
Minifast is one of IMA LIFEs many Freeze Drying Solutions. Our extensive product portfolio backed
by worldwide sales, service and technology centres enables customers with global operations to
leverage the benets of continuity across their sites.

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MINIFAST PRODUCT SOLUTIONS & TECHNICAL FEATURES

THE BASIC MACHINE IS SUPPLIED WITHIN A
PAINTED CARBON STEEL FRAME FITTED WITH HINGED
ACCESS PANELS.

CHAMBER
The chamber is a welded fabrication of
rectangular section manufactured from AISI
304L stainless steel optimised to provide
adequate access to components within the
chamber whilst minimising dead volumes.
The internal surfaces of the chamber are
mechanically polished to <0.4m Ra with
a mirror nish.

CHAMBER DOOR
The door of the chamber is fabricated from
clear plexiglass. The door is closed by means
of a manual latch.

PRODUCT SHELVES

Simple utility connections enable quick installation

Within the chamber are mounted product

support shelves and one compensation
(radiation) shelf mechanically polished to
0.4m Ra~0.6m Ra. Similar to Lyofast and
Lyomax, Minifast employs IMA LIFE unique
FusionTM design. The heat exchange uid is
supplied to the shelves via exible convoluted
stainless steel pipes that are welded to the
shelves and, in turn, welded to distribution
manifolds located outside the chamber. An
optional feature enables shelf interdistance to
be adjusted to 120 mm (Minifast 04) or 160
mm (Minifast 10) to enable taller containers
to be processed.

HEAT EXCHANGE CIRCUIT

Mimicking industrial freeze dryers, the circuit
comprises a plate cooling exchanger and
electrical heater in series through which a
heat exchange medium is circulated by a
hermetically sealed pump.

ICE CONDENSER
The cylindrical 304L condenser vessel is
mounted vertically behind the chamber. The
condensing surface within the condenser
body comprises a number of polished 316L
stainless steel pipes welded to form helical
coil(s). The coil is cooled by the direct
expansion of refrigerant supplied by the
compressor.

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OPTIONS

VERISEQ cryogenic fog

CIP

Sample thief

RABS / Isolator

Water cooled refrigeration condenser

Chart recorder

Stainless steel door and sightglass

SCADA system

Through-wall installation

Reports package

AISIL chamber & condenser

Alternate shelf inter-distance

CFR package

Product loading trays -VIALS

Pre aeration

Product loading trays - BULK

Capacitance manometer pack

Spare parts

Eutectic monitor

IQ/OQ

Chamber pressure comparison,

drying end point package

Documentation package

Installation & SAT

Additional gas supply point

IQ/OQ On-Site support

MAIN VALVE
The chamber and condenser are separate from one another and
connected by means of a vapour duct, which is equipped with a
large diameter, remotely actuated, valve.

VACUUM MEASUREMENT
AND CONTROL
The chamber is provided with a Pirani vacuum gauge. Automatic
vacuum control is achieved by a calibrated leak controlled by an
on/ o modulated solenoid valve in series with a needle valve.

REFRIGERATION SYSTEM
The air cooled refrigeration group comprises two single stage,
reciprocating, hermetic compressors installed in a cascade
conguration employing R23 and R507 refrigerants. The refrigeration
circuit is equipped with the necessary valves, lters, oil separator,
suction accumulator, condenser, sight-glasses and expansion valves
to enable the system to operate reliably and deliver the required
refrigeration performance.

VACUUM SYSTEM

CONTROLS
The control system employs a PLC with a touch screen user interface
panel to display process parameters and enable the user to control
the freeze dryer.

VIAL STOPPERING MECHANISM

An actuator is tted to the base of the chamber to raise the shelves
and generate a compression force to enable stoppers to be inserted
into vials at the end of the drying process.

The vacuum necessary for the freeze drying process is created by

use of a two stage, oil sealed, rotary vane pump equipped with gas
ballast and exhaust lter.

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LOADING SYSTEMS
Automatic loading and unloading systems minimize the risk of
contamination through human intervention in the loading and
unloading of freeze dryers. The amount of product handled when
using an automated loading and unloading process is increased since
the time spent for the loading/unloading operation is, of course,
much shorter if compared to manual loading.
Operational costs are also reduced since these state-of-the-art
systems drastically decrease the number of operators needed to
assist the freeze drying process. In some cases, the machine can be
left unattended, as well. As a consequence, the SAL levels are greater
while contemporarily reducing the operating costs.
The protection of operators also when handling potent compounds
can be achieved with these automated systems, since they can be
installed either under closed RABS or even under a proper isolator.

Fixed loading system

KEY FEATURES
The IMA LIFE automatic loaders ensure
efficient, safe and reliable performances
thanks to the following key features:

Extremely compact footprint

High throughput with loading speed

up to vpm

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High flexibility to handle different vial

size parts

Quality sanitary design

VHP (Vaporized Hydrogen Peroxide)
compliant

Pre-arranged for UAF

(Unidirectional Air Flow)

cRABS and isolator application

FIXED SYSTEMS
These are systems which are built into the
individual freeze dryers and can load each
shelf one row at a time or in packages of
several rows at a time:
Operating speed: up to 500 vials/min.
Fixed loading congurations for one, two
or four freeze dryers, with more possible
depending on cycle times, logistics and
process environment
Choice of type of loading pusher
Mainly loading and unloading from the
same side
Isolator or cRABS
Flexible loading system in production area

FLEXIBLE SYSTEMS

DA VINCI: THE LATEST GENERATION OF VIAL LOADING

AND UNLOADING SYSTEMS

Extremely compact
footprint with
integrated loading and
unloading module
Wi-fi technology (Patent
Pending)
High throughput with
speeds up to VPM

Quality sanitary design

VHP compliant
Pre-arranged for
isolator application
Excellent integration
with freeze dryers

These are systems using transporters or

robots to serve multiple freeze dryers on
shelf at a time:
Operating speed
- Loading: up to 500/600 vials/min.
- Unloading: up to 900 vials/min.
This system is primarily used for multiple
freeze dryers
Mainly loading and unloading from
same side
Suitable for pass-through system
congurations

MIXED SYSTEMS
These systems oer a combination of xed
and exible solutions:
Only pass-through congurations
Operating speed:
- Loading: up to 500 vials/min.
- Unloading: up to 900 vials/min.
Fixed loading and exible unloading
Flexible loading and xed unloading

DA VINCI wireless version

25

IMA LIFE INNOVATION

Technology has always been at the heart of everything we do. In putting this technology to work
and gaining control of development time and the expense of customer engineering, we apply
Modular Design Technology (MDT). This provides the opportunity for the well-balanced use of
pre-engineered modules in a customers application.

26

FUSIONTM

FUSIONTM PLUS

SAFETHERM HXTM

The Fusion patented shelves bring innovation

to the heart of the freeze drying process.
Fusion technology enhances freeze dryer
performance whilst reducing your operating
costs. The Fusion shelves are lighter, atter
and stronger than conventional freeze dryer
shelves resulting in improved heat transfer
properties and a reduction in volume of
required heat transfer uid. The Fusion
manufacturing process is fully automated
ensuring higher quality assurance that
reduces your risk and increases the reliability
for your process.

When presented by our customers with

the challenge of providing a solution to the
problem of stoppered vials sticking to the
underside of product shelves, we responded
with investment in an R&D programme
that resulted in a truly innovative solution.
Fusion Plus extends the Fusion technology
by utilising a patented surface treatment
that eliminates the occurrence of sticking
stoppers. This avoids potential disruption of
the vial pack and the associated disruption
of automated vial unloading that has become
an increasing problem for the industry.

With SafeTherm HX we can now provide an

inert, non-ammable, ultra-low viscosity heat
transfer uid for freeze dryer applications.
This industry leading development is a
further example of intelligent technological
evolution in our products that results in an
improved freeze drying process combined
with reduced risk for our customers.

IMA LIFE HAS BEEN

CONSISTENTLY
AT THE LEADING EDGE
OF FREEZE DRYING
AND LOADING SYSTEMS
INNOVATION PUTTING
NEW TECHNOLOGY
TO WORK FOR OUR
CUSTOMERS.

VERISEQ NUCLEATION

ENABLING PAT

PROCESS OPTIMISATION

During freeze drying, the freezing step is

considered the foundation to a repeatable
and ecient process. A good freezing
process can produce a consistent product
and enable faster primary and secondary
drying cycles.
Ice fog nucleation is a means to control
ice nucleation using a sterile cryogenic fog
that is applicable to laboratory, pilot and
production scale lyophilizers.
This technology is highly adaptable and can
be retrotted to most freeze dryers with
minimal impact on established lyophilization
protocols.
To provide improved process control to its
customers, IMA LIFE has joined forces with
Linde Gases (a Linde Group division) for the
implementation of Lindes proven VERISEQ
technology.

The goal of the FDAs Process Analytical

Technology (PAT) initiative is to understand
and better control the manufacturing
process. Quality cannot be tested into
productsit should be built-in or should be
by-design.

Our laboratory facilities and equipment,

including Lyoux, as well as our onsite experts can oer customised cycle
development studies with the ultimate goal
to optimise the freeze drying process.

IMA LIFE is committed to research and

engineer in-house and in partnership
with specialist technology providers and
customers to develop solutions aligned
with the PAT initiative: pharmaceutical and
biological drugs which are produced through
safe, consistent, repeatable, reproducible
processes.

27

IMA LIFE SERVICES

With our worldwide presence

and highly talented and
proactive staff, we can help
you any time.

We take pride in our

responsive approach

We can offer you service

contracts tailored to
your individual needs

We can guarantee
optimal performance
of your systems
at any point in time

On top of our
comprehensive Spare
Parts programmes, we
offer a wide range of
value-adding services
wherever you are.

PREVENTATIVE MAINTENANCE PROGRAMMES

These are an integral part of our cGMP approach. All maintenance will be properly documented
to support you during corporate audits and regulatory inspections. The preventative maintenance
programme will:
Assure compliance and continuity of your validated equipment status
Make the operation of your equipment reliable
Minimise downtime
Considerably extend your equipment LIFE-span.

28

CONTROL SYSTEMS UPGRADES

We can support you in assessing your control
system with respect to compliance with
current regulations, including GAMP IV and
V and CFR part . Upgrades are available
for SCADA, PLC, and Field instrumentation
and are fully debugged and bench tested
in a simulation environment through to
FAT and SAT. They include a fully compliant
documentation package and can include:

Validation master plan

User requirements specification

Design qualification/traceability matrix

Functional design specification for PLC

Block diagrams
Pin chart

Functional design specification

for SCADA

Hardware design specification

Software design specification for PLC

and SCADA

FAT (Factory Acceptance Tests) and

SAT (Site Acceptance Tests)

Test protocols.

VALIDATION SUPPORT
IMA LIFE can provide you with an omni-comprehensive package of
documentation for on-site validation. The package can include DQ,
IQ, OQ and PQ protocols and support by specialists for execution.
We can support your equipment qualication with a variety of
dierent approaches:
Integration between commissioning and qualication. Based on
written procedures, approved by you, we dene rules (deviation
management, project change control, etc.) to limit the duplication
of eort between FAT/SAT and IQ/OQ/PQ
Risk analysis-Through the analysis of the critical process parameters
and written rationale, we support you in dening the scope of
the qualication, setting up initial and periodic qualication
programmes, and integrating the commissioning and qualication
eorts.

29

IMA LIFE SERVICES

FREEZE DRYING CYCLE DEVELOPMENT
Our laboratory facilities can offer a complete
set of equipment and facilities for cycle
development study, enabling focus on:

Optimising the freezing temperature and

cooling time

Vacuum to optimise the heat transfer

from shelves to product avoiding
undesirable melting

Product temperature to optimise the

primary and secondary drying time
modifying the shelf temperature and
vacuum with calibrated leak (nitrogen
gas bleeding)

The secondary drying phase using

calibrated leak and shelf temperature
to reduce time and meet the customer
request for residual moisture

Measurement of the residual moisture

Karl Fischer analyser to verify the

residual moisture after lyophilisation

DSC analyser to verify the eutectic point

and phase transitions.

CALIBRATION SERVICES
Calibration must fulll both maintenance and compliance
requirements. We can develop a comprehensive programme for
you using our extensive experience. Gain direction for classifying
instruments and setting appropriate limits to ensure product quality.
Avoid unnecessary deviation investigations. We can also provide
you with calibration procedures and perform calibration of your
instruments with highly qualied technicians and fully traceable
primary instruments.

TRAINING SERVICES
We oer a variety of training programmes for Machine operators,
Electrical and Mechanical engineers, Maintenance engineers, and
Supervisory personnel.
Our programmes are designed not only to improve the participants
overall understanding of the production equipment, but also to
enhance their condence and performance levels to provide you
with a benecial return for your business.
Training programme options:
Level 1: System fundamentals, operation and error recovery
Level 2: Preventative maintenance techniques
Level 3: Corrective maintenance techniques
Train the trainer: Course development and material delivery.

30

We can assess the mechanical set up and

performance of your freeze drying systems:

UPGRADES & REFURBISHMENT

Following a customised investigation programme, we can provide
tailored maintenance and/or replacement programmes as part of
your assessment, including items such as:

Equipment integrity

Performance improvement

Regulatory compliance

Extension of LIFE span.

DESIGNING OUR SERVICES TO MATCH

OUR CUSTOMERS ONGOING NEEDS
THROUGH THE PRODUCT LIFE CYCLE.

Piping/valves
Sterile lter rack
In-line automatic and non-automatic lter integrity test
Hydraulic unit
Shelf stack
Vacuum line
Vacuum pumps.
All are normally covered by our investigation and can be
implemented with customer specic/equipment specic checks.
IMA LIFE has a long experience with various compressors and
refrigeration technology and is able to review and optimise the
performance of your refrigeration skid, including:
Reciprocating compressors
Screw compressors
Liquid nitrogen
Variable speed drive
Electronic expansion valves
Pressure transducers .
31

IMA LIFE IN THE WORLD

Group Headquarter:
IMA LIFE division
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS
Via Emilia, 428/442
40064 Ozzano Emilia - Bologna - Italy
Phone +39 051 6514111
Fax + 39 051 6514821

North American Regional Headquarters:

2175 Military Road
Tonawanda, NY 14150 USA
Phone +1 716 6956354

European Service Centre:

De Leest 3
Dongen, 5107 RC, The Netherlands
Phone +31 162383500

Asian Regional Headquarters:

No.3 JianAn Street, BDA (Yizhuang),
100176 Beijing,
Peoples Republic of China
Phone: +86 10 59623866 899

IMA LIFE Japan K.K.:

Kuramae Sanyo Bldg. 7F 2-42-5
Kameido - Koto-ku Tokyo 136-0071 Phone: +81 (0) 3 5626 9151
Fax: +81 (0) 3 5626 9158

sales@imalife.com
services@imalife.com

Lyomax, Lyofast, Minifast, FusionTM - Fusion PlusTM, SafeTherm HXTM

are registered trademarks of IMA LIFE.

For information on the IMA subsidiaries

and sales offices, visit our website:
www.ima-pharma.com (contacts section)

32

April 2014 - 991ZS020102

IMA S.p.A. reserves the right to make any changes to the described machine characteristics.

www.ima-pharma.com

IMA S.p.A.
IMA LIFE division
Via Emilia 428-442 - 40064 Ozzano dellEmilia (Bologna) - Italy
Tel. +39 051 6514111 - Fax +39 051 6514666
mktg.LIFE@ima.it - www.ima.it