Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market...

24
Competence in Lyophilization Systems

Transcript of Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market...

Page 1: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Competence in Lyophilization Systems

Page 2: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

2 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 3: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

For more than 60 years, GEA has designed and

manufactured integrated freeze drying systems for

the biopharmaceutical industry: from laboratory and

pilot-scale products for R&D and small production

batches to complete, industrial-scale solutions,

including ALUS™, integrated isolators and CIP-skids.

With our extensive portfolio of loading systems,

and our expertise and know-how, we can ensure

maximum performance with high flexibility.

As a long-term partner to the pharmaceutical and

biotech industries, our equipment stands for high

performance, reliable and trouble-free operation.

And, with more than 200 validated ALUS™

installations, worldwide, we have an unparalleled

history of innovation for various pharmaceutical

applications that demonstrate our capability.

Whether filler or capper, our extensive experience in

interface design guarantees the smooth integration

of a perfectly harmonized production line. We

can help you to determine whether your specific

application requires an ALUS™ with open or closed

RABS (cRABS), isolators or the use of a stationary

push-pull system, based on your containment

requirements and product details.

Increasingly stringent health and safety

requirements for aseptic manufacturing and

contamination prevention have driven the

development of ALUS™, to which GEA has made

a major contribution. Automating the production

process and reducing the use of isolators has made

it possible to decrease human intervention in sterile

areas and minimize contamination risks.

Competence in Lyophilization Systems

GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of over 1000 Freeze Dryer installations worldwide, and has installed over 200 production systems that include automatic loading systems (ALUS™)

COMPETENCE IN LYOPHILIZATION SYSTEMS · 3

Page 4: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Delivering the Right SolutionsGEA’s process expertise is based on experience and innovation secured by R&D

Having completed thousands of tests in GEA’s own

Liquid Dosage test area, the company has established

a solid base of expertise related to the needs of

the pharmaceutical and biotech industries.

Every GEA freeze dryer is designed to help customers

to create a product that will succeed in the market,

with GEA being a partner in reaching that goal.

GEA’s range of supplies and services comprises:

pilot-scale freeze dryers for R&D purposes and small

production batches; industrialsize freeze dryers; and

complete freeze dryer systems including Automatic

Loading and Unloading Systems (ALUS™). In addition, the

company services and retrofits existing freeze dryers.

The design and manufacture of freeze dryers and

freeze drying systems is done in accordance with all

cGMP, CE, GAMP5 and 21 CFR Part 11 guidelines.

The company’s expertise in freeze drying and related

processes — isolator technology, sterilization and clean-

in-place (CIP) — covers all kinds of pharmaceuticals and

biotechnology derived products, such as hormones, vaccines,

antibiotics anti-infectives, bacteria, sera, enzymes, diagnostic

agents, monochlonal antibodies (MABs) and blood products.

4 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 5: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Application SupportFreeze drying (lyophilization) has a key role in aseptic pharmaceutical and biotech production as the main fill and finish process

Freeze dried products retain their original

properties. By adding water or other solvents, they

can be reconstituted easily and very quickly.

Freeze drying is widely used as a preservation

method. Each product requires the optimization

of specific parameters during lyophilization. This

includes the initial freezing process, which is of

great importance for the structure of the final

product. The selected shelf temperatures and the

corresponding sublimation pressure during primary

drying not only determine the drying time, but also

the quality of the final product. Typical quality aspects

are retention of original properties, appearance

of the cake, reconstitution time and shelf-life.

The freezing and melting behavior of the product

is tested in the laboratory to establish the correct

outcome from the start. The test results then form

the parameters for further pilot testing to develop

the freeze drying process, reduce time to market

and ensure reliable scale-up to full production.

GEA helps its customers in both the

pharmaceutical and biotech industries to

optimize their lyophilization processes.

COMPETENCE IN LYOPHILIZATION SYSTEMS · 5

Page 6: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

In-depth process understanding

GEA provides standard or customized solutions based on

proven technology and a thorough understanding of the

individual requirements for applications including bulk APIs,

blood plasma, vaccines, hormone, antibiotics, anti-infectives,

bacteria, sera, enzymes and diagnostic agent production.

Plant configuration extends from specialized solutions

for highly potent products and all layout requirements,

and from two story units up to fully integrated systems

with multiple freeze dryers and loading systems.

• More than 60 years experience in lyophilization process

development, engineering and manufacturing

• More than 1000 freeze dryers and automated loading/

unloading systems in production globally

• References in compliance with cGMP, CE,

GAMP and 21 CFR Part 11 guidelines

• Customer base includes major pharmaceutical companies,

contract manufacturers and generics manufacturers,

demonstrating the operational reliability, quality

and productivity of GEA equipment

Our pilot-scale freeze dryers are available either

with steam or H2O2 gas sterilization and our

production units can be steam sterilized.

We care about your business

Superior performance, reliability and cost-effective

production combine to keep you ahead of the competition.

Freeze Dryer Product Portfolio

Technology Leadership

LYOVAC™ Freeze Dryer FCM 600-D

6 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 7: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Production Freeze Dryer

LYOVAC™ FCM 600-D

LYOVAC™ FCM 600-D

Condenser of LYOVAC Freeze Dryer

COMPETENCE IN LYOPHILIZATION SYSTEMS · 7

Page 8: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

8 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 9: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Plants customized for success

Every pharmaceutical system and unit from GEA is a unique

and efficient combination of proven technology and solutions

that’s individually configured for cGMP production to reflect the

specific customer’s needs

GEA can deliver the right size and performance to meet your

output demands, the right configuration for your production

and process requirements, and the right barrier technology to

eliminate contamination risks.

A partnership in every perspective

Working with GEA means entering a professional partnership

that continues every step of the way: from first process/product

testing and plant design to start up, installation, commissioning

and professional support during years of productive operation.

GEA’s unique service program and retrofit concept ensures an

optimized return on investment throughout the lifetime of

the plant.

Total cost of ownership

Buying a freeze drying system means starting a relationship

between a customer, the equipment and a supplier for 20 or more

years. Looking at the total cost during the lifetime of a plant is

essential for our clients in today’s competitive landscape. GEA has

focused all its efforts on developing smart solutions that provide

tangible benefits in terms of the efficiency and productivity of

their freeze drying plant. Green, low-energy technology, state-of-

the-art components and unique equipment design ensure the

most economical operation of the plant. At the same time, the

outstanding quality of the equipment and specific conditional

maintenance programs ensure uniquely high plant performance

and availability, which leads to increased productivity for the user.

All our efforts serve one goal: to make our customers perform better

and more cost effectively – long term.

E-STAR™ energy saving concept

Freeze drying is an energy intense operation. Yet, with

E-STAR™, process efficiencies of up to 40% are possible.

Although the process of freezing and water sublimation can’t be

changed, E-STAR™ provides a way of reducing both media and

and electricity consumption.

It addresses the need to select highly energy efficient

components and evaluates the specific energy/media

saving technologies that are available.

Efficient Freeze Drying for Greater Productivity

Each project is different but the goal is the same: high quality and cost efficiency

INTEGRATED FATto verify the performance and functionality

of the integrated system.

COMPETENCE IN LYOPHILIZATION SYSTEMS · 9

Page 10: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Process Analytical Technology (PAT)for Lyophilization: LYOPLUS™

The LYOPLUS™ mass spectrometer is a multipurposemeasurement device for pharmaceutical freeze drying

Originally developed to detect very small traces of silicone

oil inside freeze dryers, the LYOPLUS™ mass spectrometer

is fitted with advanced software that facilitates the collection

and measurement of data than wouldn’t be possible with

ordinary equipment. The system is able to work alongside any

existing PLC/SCADA system as a standalone unit or can be

fully integrated into the control system. It can also be operated

independently as a monitoring device that does not interfere

with any qualified processes. In addition to being able to

detect trace levels of silicone oil, thereby preventing product

contamination, LYOPLUS™ is also able to monitor the moisture

content in the freeze drying chamber during the drying cycle

— helping to define primary and secondary drying endpoints

— and reduce leak detection times down to just one hour.

LYOPLUS™ performs all these three tests in one single unit,

improving productivity, reducing power consumption and the

environmental impact of the process, and saving the user time

and money.

Silicone oil detection

Silicone oil is used to transfer heat energy to the product. After

years of operation, the harsh conditions in the dryer can lead to

small leaks and, as a consequence, end product contamination.

Eventually, as the leak increases, silicone oil is detected during

end product testing in quality control. But how many batches

have been contaminated? With LYOPLUS™, it is possible to

detect even small traces of silicone oil during the operating

cycle. No additional product is at put risk as the leak is detected

immediately.

Moisture content

At the start of the drying process, the chamber fills with product

derived water vapour. During the later stages, however, the

moisture level decreases significantly. LYOPLUS™ measures this

drop and correlates the data with the average product moisture

levels in the vials. This information can be used to refine drying

recipes, avoid any unnecessary drying time and predict product

drying curves based on the chamber’s moisture content.

Chamber leak tests

To prevent leak-based contamination, it is mandatory to perform

a leak test after each critical process. Using LYOPLUS™, it is

possible to reduce the time for this standard procedure down

from four hours to approximately one hour, owing to its very

high sensitivity. And, as LYOPLUS™ is permanently connected

to the system, helium leak tests can begin instantly, improving

detection times and productivity.

In short, LYOPLUS™ detects impurities before quality problems

arise, saving both time and money, and plays a key role in

maintaining high standards of safety, quality and productivity.

Technical Data

• Fully automated

• Fail-safe operation to ensure sterility and protect the

lyophilization equipment and the measurement device

• Standalone or optional full SCADA implementation

• High performance quadrupole mass spectrometer system

• Mass range: 1-100 standard

• (1–200 AMU or 1–300 AMU optional)

• High conductance inlet system

• Max. operating pressure: 1 mbar

• Detection limit: 1ppm of non-interfering species

10 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 11: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

COMPETENCE IN LYOPHILIZATION SYSTEMS · 11

Page 12: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

A History of Innovation

Since the 1980s, GEA has designed, manufactured and improved the ALUS™ system and was one of the first manufacturers to develop this technology using permanently installed systems (conveyor-pusher systems), as well as flexible transfer cart systems

In 1997, the first isolator-contained ALUS™ went

into operation. Since then, several patents have been

filed that cover smooth docking flaps to reach the

freeze dryer shelves, for example, and the swivel

table. Consequently, in 2009, the decision was made

to bring design, engineering and production in

house to further develop the system and improve

integration.

Available as a manually operated, semiautomated

and fully automated system, depending on user

requirements, ALUS™ offers yet another advantage:

unproductive loading times can be significantly

reduced.

The use of a transfer cart, when combined with

several freeze dryers, is particularly effective, as

formatting and loading can be run in parallel. A high

throughput rate of 500 vials/min. (loading) and a

maximum speed of 800 vials/min. (unloading) can

be achieved, with both ALUS™ systems. Tool-free

size changes can be done quickly and easily, simply

by exchanging prefabricated parts. A fully automatic

size change for 2–50 mL vials is also possible. As

such, the overall turnaround time is greatly reduced,

which also benefits the customer in terms of total

cost of ownership.

ALUS™ Automatic Loading and Unloading Systems

minimize the risk of operator/product contamination

while loading and unloading a freeze dryer. Offering

shorter cycle times, improved productivity and, using

state-of-the-art monitoring systems, they also reduce

operational costs.

12 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 13: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

ALUS™ Transfer Cart

Production Line with ALUS™ Cross moveable Transfer Cart

COMPETENCE IN LYOPHILIZATION SYSTEMS · 13

Page 14: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Increased Productivity and Better Contamination Control

14 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 15: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

COMPETENCE IN LYOPHILIZATION SYSTEMS · 15

Page 16: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Containment/Barrier Systems

Restricted Access Barriers Systems (RABS) are another way to

reduce the interventions that can occur in cleanroom processing

through the use of a barrier and dynamic air flow, and can be a

viable alternative to isolators.

Both are devices that provide a physical and aerodynamic

(air overpressure) barrier between the external cleanroom

environment and a work process. The isolator design is the

more dependable of the two barrier design choices as it prevents

contamination hazards by achieving a more comprehensive

separation of the processing environment from the surrounding

facility. Nonetheless, both isolator and RABS designs are

contemporary approaches that have continued to develop during

the last 35 years and offer significant advantages compared

with previous solutions that were far more prone to microbial

contamination problems.

Aseptic processing evolved in the 1980s and 1990s with the use of isolators to separate the operator from the “critical zone” and thus reduce product risk

16 · COMPETENCE IN LYOPHILIZATION16 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 17: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Barrier and isolator systems are widely used in a number

of industries; in pharmaceutical processing — from sterile

injectable drug filling to cytotoxic sterile drug compounding —

they are primarily employed to maintain the sterility of a drug

product. Furthermore, automatic loading and unloading systems

such as GEA’s ALUS™ minimize the risk of contamination by

human intervention during the loading/unloading of freeze

dryers. Product handling rates are much higher when using

an automated process as the time spent loading/unloading the

freeze dryer is much shorter compared with manual loading.

And, as these state-of-the-art systems significantly reduce

the number of workers needed to operate the machinery,

manufacturing costs are also much lower. Plus, as some

procedures can be done unattended, SAL levels are

concomitantly higher. Perhaps more importantly, greater levels

of operator protection can be achieved, particularly when

handling potent compounds.

Caption caption caption caption

COMPETENCE IN LYOPHILIZATION SYSTEMS · 17

Page 18: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

The ALUS™ transfer cart system takes the whole process further

by offering a flexible layout, more compact design, an advanced

control system, easy docking under laminar flow, open RABS

and the ability to expand the system by adding additional

freeze dryers when production demands increase. Formatting

and loading can run in parallel, thus optimizing the process.

The mobile Transfer Cart System distinguishes itself owing

to its high flexibility when charging several freeze dryers. The

application of the unique gapless docking technique – no gap

between the freeze dryer and transfer cart – means that we can

guarantee maximum product protection and ensure that the

transfer of the vials occurs under a constant laminar flow.

Both designs are extremely adaptable with regard to primary

packing and the degree of automation. Modifications

can be made, according to demand, within a range from

manual to fully automatic handling. Both systems can

be executed in accordance with the ATEX guidelines,

are modular, and can be retrofitted to existing units.

The new transfer cart ALUS™ is controlled using a state-of-

the-art wireless W-LAN panel. This provides precise control

of the system without requiring a hard-wired connection. The

wireless panel is much easier to handle when operating in a

cleanroom and is easier to clean than hardwired equipment.

Up to ten freeze dryers can be loaded and unloaded with

a single ALUS™ transfer cart system (depending on the

application) so, as a system grows, additional production can

easily be accommodated. This is a more flexible system than

fixed push-pull equipment and much more cost-effective.

The GEA ALUS™ stands for safety,

performance, flexibility and reliability

• High performance by charging of up to 800 vials/min and

discharging of up to 700 vials/min

• Frameless operation

• High flexibility when operating with different vial forms

• Proven operational safety, even for difficult vials (diameter-

height ratio of <3) owing to our unique patented design

• Superior sterile design with excellent laminar flow properties:

no moving parts above open vials so as to increase safety and

avoid product contamination

• Optimum interface co-ordination with upstream and

downstream equipment

• Zone-type construction for containment according to product

flow requirements

ALUS™ Transfer Cart SystemDisposable, low-cost high containment materials handling

ALUS™ Transfer Cart Unloading Table ALUS™ Transfer Cart with formatting and unloading table

18 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 19: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

ALUS™ from GEA represents safety, performance,

flexibility and reliability. Key features include

loading speeds of up to 500 vials per minute and

unloading speeds of up to 700 vials per minute,

high operational safety, even for difficult vials with a

diameter:height ratio of <3, high levels of flexibility

for different vial formats, excellent integration of

ALUS™ and the freeze dryer through optimum

interface coordination and integration, patented

design allows smooth transition of vials from ALUS™

to the freeze dryer, design complies with zone

concept: no machine drives in vial processing area,

frameless operation, high quality sterile design with

excellent laminar flow properties, no moving parts

above open vials increases safety and avoids product

contamination, and easy-to-use integrated software.

In 1989, the ALUS™ system instigated a paradigm

shift in lyophilization technology: back then, the

freeze dryer was the main element in a sterile

production supply chain; now ALUS™ is the key

component: a vital part of contamination risk

minimization during safe and sterile production.

Stationary push-pull system

The decision to use ALUS™ will be based on

specific containment requirements and product-

related details. If it is necessary to use ALUS™

in conjunction with closed RABS (cRABS) or

isolators, then a fixed conveyer-pusher system

should be deployed. It is not only designed

for use with cRABS, but also in an isolator.

Stationary Push-Pull System ALUS™ Buffer conveyor

COMPETENCE IN LYOPHILIZATION SYSTEMS · 19

Page 20: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

ALUS™ Options

• unique marking of your

primary packaging

• clear characterization in

accordance with the new EU

counterfeiting directive

• 100% traceability

• a continuous quality inspection

• 100% line clearance (packaging

reporting procedure)

• precise sampling

• extensive process monitoring

To further enhance the productivity of GEA’s Automatic Loading

and Unloading Systems (ALUS™), a range of cost-effective

modular options is available to customize your freeze drying

system. Each module and system component meets strict

safety and regulatory requirements, and has been designed to

guarantee optimal product quality and high throughput rates.

100% Vial Traceability – LYODATA™

In collaboration with SCHOTT and HEUFT, GEA has developed

LYODATA™ a vial traceability solution that will help the

pharmaceutical industry to implement the EU’s drug anti-

counterfeiting directive, safeguard the rights of trademark

and patent holders and, ultimately, protect patients. We collect

data from fill to finish — at every step of the process — which

enables us, amongst others, to ensure distinctive marking for

complete traceability.

20 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 21: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Backpusher

The ALUS™ Backpusher provides the following

benefits: improved user access and cleanability, cost-

effective containment (only the product zone needs to

be LAF protected) and enhanced leak test compatibility.

Furthermore, all moving parts are bellows protected and

completely contained within the freeze dryer chamber,

facilitating CIP/SIP procedures. In addition, the system

is fully Annex 1 compliant, with no parts present above

the vials during unloading, and suitable for flat front and

isolator containment operations.

Bellow pusher

Providing a clear and defined barrier between the

product and user areas, the ALUS™ Bellow pusher

offers improved cleanability, better user access and a

cost-effective containment option (only the product zone

needs to be LAF protected). All moving parts are bellow

protected and, like the Backpusher, flat front and isolator

containment is possible.

Starwheel

During freeze dryer loading, the ALUSTM starwheel

module serves to position, count and stop — if necessary

— the vials received from the infeed conveyor to a pusher

conveyor. With processing speeds of up to 500 vials/min,

the starwheel is both time- and cost-efficient and comes in

an easy to modify format for rapid product changeovers.

Cold shelf loading

The ALUS™ cold shelf loading module from GEA offers

an efficient way to load vials onto precooled freeze dryer

shelves. Prepared vials are transported by the intermediate

pusher to the final shelf position at a rate of up 400 vials/

min. No additional change parts are required, there’s no

extra cost involved and no added buffer time for shelf

changing. In addition, the number of moving package

rows is freely selectable using the existing HMI software.

Single row unloading

Fully compatible with all types of containment (oRABS,

cRABS, isolator), the ALUS™ single row unloading

module from GEA offers an efficient way of unloading

single rows of vials at speeds of up to 400 vials/min.

The patented design provides easy vial sample handling

(track and trace) and optional vial traceability.

Vial Traceability

ALUS™ with Backpusher

ALUS™ Bellow Pusher

ALUS™ with Starwheel

COMPETENCE IN LYOPHILIZATION SYSTEMS · 21

Page 22: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

GEA will be your partner during every step of your project

including: cycle development, analysis of your initial project

requirement, selection of the best suitable layout and right

size and system performance, equipment engineering and

manufacture, commissioning of the plant, training and lifetime

support by our service team and process experts. GEA will

be your partner during every step of your project including:

cycle development, analysis of your initial project requirement,

selection of the best suitable layout and right size and system

performance, equipment engineering and manufacture,

commissioning of the plant, training and lifetime support by our

service team and process experts. Everything from one source

and based on 60 years of freeze drying expertise.

GEA Freeze Drying Systems include the actual freeze dryer and

the automatic loading and unloading system ALUS™ integrated

in one package. From concept through design, assembly and

FAT, it’s a seamless approach without an external interface.

The benefit of this integrated concept has been tested during

FAT testing of actual performance with vials. This ensures

the smooth operation of the complete plant and proof of

performance before the equipment is shipped to site. Our

customers can be assured of a consistent security of outcome;

we take responsibility.

• Our Service Team offers 24/7 HOTLINE support.

• Intelligence built into the system, with our conditional

maintenance program, ensures the operational

availability of the plant and the highest productivity.

• Working with GEA means entering into a partnership

with dedicated experts who all have one goal: to

support you to be the best in your business.

• Planning and engineering are carried out completely in

3D CAD.

• Mock-up is carried out together with our customers to

facilitate optimum ergonomics during operation.

• Our specialists are in control of all site activities including

SAT and training of the operators to ensure that the

plant can be put into operation reliably and quickly.

• We will assemble the complete system for FAT and

demonstrate its lifetime performance. This facilitates

quick and smooth commissioning on-site.

• Our specialists are in control of all site activities including

SAT and training of the operators to ensure that the

plant can be put into operation reliably and quickly.

Lifecycle PartnershipGEA will be your partner during every step of your project

Service,preventive

maintenance,Retro�t

Planning &Engineering

Commissioningand Start up

Projectexecution,Assembly

and FAT

22 · COMPETENCE IN LYOPHILIZATION SYSTEMS

Page 23: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

Our specialists are in control of all site activities.

COMPETENCE IN LYOPHILIZATION SYSTEMS · 23

Page 24: Competence in Lyophilization Systems (2...Lyophilization Systems GEA is one of the world’s market leaders in Freeze Drying / Lyophilization technology with a reference record of

GEA Group is a global engineering company with multi-billion euro sales and operations in more than

50 countries. Founded in 1881, the company is one of the largest providers of innovative equipment and

process technology. GEA Group is listed in the STOXX® Europe 600 Index.

We live our values.Excellence • Passion • Integrity • Responsibility • GEA-versity

GEA Lyophil GmbH

Kalscheurener Straße 92,

50354 Hürth, Germany

Tel +49 (0) 2233 6999 0

[email protected] gea.com © G

EA G

roup

201

7 (P

harm

a). S

peci

ficat

ions

sub

ject

to

chan

ge w

ithou

t no

tice.

All

trad

emar

ks r

ecog

nise

d.A

ll co

pyrig

hts

rese

rved

. Und

er n

o ci

rcum

stan

ces

shou

ld t

his

docu

men

t or

any

par

t of

it b

e co

pied

with

out

writ

ten

cons

ent.