As a long-term partner to the pharmaceutical
and biotech industries, our equipment stands
for high performance, quality and reliable,
trouble-free operation. Every GEA freeze dryer
is designed to help our customers to create a
product that will succeed in the market — with
GEA being a partner in reaching that goal.
Our range of supplies and services includes
pilot-scale freeze dryers for R&D purposes
and small production batches, industrial-
scale freeze dryers and completely integrated
systems, including Automatic Loading and
Unloading Systems (ALUS®) and CIP skids. 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 relevant guidelines, such
as GMP, GAMP5 and 21 CFR Part 11, as well as
other worldwide regulatory requirements, such
as CE, UL, ASME, BPE and PBD.
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, monoclonal
antibodies (mAbs) and blood products.
And, with more than 250 validated ALUS®
installations, worldwide, we have an
unparalleled history of innovation for various
pharmaceutical applications that demonstrate
our capability.
Delivering the Right Solutions
GEA’s process expertise is based on a long history of innovation, applied R&D and industry experience
FREEZE-DRYING SOLUTIONS · 3
Freeze Drying EssentialsFreeze drying (lyophilization) has a key role to play in aseptic pharmaceutical and biotech production as fill and finish process
From its earliest applications in the stabilization of blood
plasma, freeze drying has been in use in the life science
industries for more than 50 years. During this period,
the freeze dryer — or lyophilizer — has evolved from a
simple device for vacuum drying at low temperature to an
extremely sophisticated integrated system that combines a
number of processes to ensure that a product is consistently
delivered to technical and biological specifications while also
considering economic, safety and environmental issues.
Freeze drying is a dehydration process typically used to
preserve a perishable material or make the material more
convenient for transport or storage. Freeze drying works by
freezing the material and then reducing the surrounding
pressure to allow the frozen water in the material to
sublimate directly from the solid phase to the gas phase.
Generally, the freeze drying process is done in three steps, under
vacuum: freezing, primary and secondary drying. The product
to be dried is frozen under atmospheric pressure. Then, in an
initial main or primary drying phase, water, in the form of ice,
is removed by sublimation; in the secondary drying phase,
it is removed by desorption. The reduced moisture content
improves the stability and shelf-life of the product; but, in some
instances, rehydration can further improve those properties.
The fourth step, rehydration, can be implemented after
the secondary drying phase. During rehydration, low
concentrations of moisture are intermittently added to
the chamber until the required moisture content of the
product has been reached. The length of the rehydration
phase is product- and moisture content-dependent.
4 · FREEZE-DRYING SOLUTIONS
GEA provides standard or customized solutions based on
proven technology and a thorough understanding of the individual
requirements for specific applications. Plant configuration extends
from specialized solutions for highly potent products and layout
requirements, and from two story units up to fully integrated
systems with multiple freeze dryers and loading systems.
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 (Restricted Access Barrier Systems) or isolators, based
on your containment requirements and product details.
Offering a variety of both cost-effective standard and highly customized
options, GEA’s modular equipment extends from R&D to standalone
production plants and high-capacity systems for bulk product applications.
• Production: SMART LYO® SL 100–SL 600 systems are constructed
on a single-floor plant frame for fast, simple commissioning
and include the compact chamber/condenser unit, all system
modules (hydraulics, venting system, vacuum) and available
options such as CIP and SIP, interfacing to ALUS®.
• Production: LYOVAC® customized industrial freeze dryers designed
in accordance with the lates cGMP regulationns. Ranging from 5-60
m² up to 1000 kg ice condenser capacity. The layout can be arranged
on one or multiple floors in the building. Industrial freeze dryers
(shelf size 5–60 m2) for large-scale production plants are also available
and can be built to customer specifications. Small scale production
including high potent materials. Variosys FCM 75i and FCM 150i.
LYOSPARK® Nucleation Technology
LYOSPARK® controlled nucleation technology from GEA facilitates uniform
ice crystal formation in laboratory and production-scale freeze dryers with
a minimum degree of supercooling. This is reflected in more consistent and
larger ice crystal sizes with a more open product structure. As a result, faster
drying and reconstitution times can be achieved. In addition, LYOSPARK®
ensures inter-batch homogeneity, improves process repeatability and
enhances both the presentation and quality of the final product.
Freeze Drying
LYOVAC® FCM 600-D
shelf package
LYOVAC® FCM 600-D
Application support
6 · FREEZE-DRYING SOLUTIONS
Standard LYOVAC® Models
Units FCM 200 FCM 400 FCM 600 FCM 800
Chamber
Geometry Form Rectangular Rectangular Rectangular Rectangular
Shelves
Shelf area m² 10 20.4 30.2 41.22
No. of shelves Quantity 9 + 1 11 + 1 13 + 1 15+1
Shelf size mm 914 x 1219 1219 x 1524 1524 x 1524 1524 x 1803
Clearance mm 125 125 125 125
No. of vials (Ø 16mm) Batch size 42,759 87,527 129,662 177,000
No. of vials (Ø 22mm) Batch size 22,464 46,057 68,302 93,240
No. of vials (Ø 30mm) Batch size 11,970 24,607 36,530 49,875
Shelf temperature °C -55 … +70 -55 … +70 -55 … +70 -55 … +70
Condenser
Geometry Form Cylindrical Cylindrical Cylindrical Cylindrical
Position Laterally / behind Laterally / behind Laterally / behind Laterally / behind
Type Tube Tube Tube Tube
Nominal ice capacity kg 200 400 600 800
Chamber \ Condenser Valve
Type Mushroom Mushroom Mushroom Mushroom
Clear diameter mm 500 700 900 1000
Weights
Chamber and condenser (empty) t 12.5 15 17.5 20
Utility Consumption
Units FCM 200 FCM 400 FCM 600 FCM 800
Utilities
Pure steam barg 1,5 1,5 1,5 1,5
°C 127 127 127 127
Consumption for sterilization* kg 240 385 460 560
Consumption for defrosting kg 80 110 240 320
CIP water barg 3-4 3-4 3-4 3-4
Temperature °C 80 80 80 80
Consumption* m3 2,6 3,4 4,2 5
Cooling water (Compressor) °C < 25 < 25 < 25 < 25
Peak flow m3/h 9 12 15 19
Consumption* m3 138 175 212 267
Electrical power supply kW 105 140 175 210
Power Consumption per Cycle*
With compressors KWh 650 900 1250 1700
With liquid nitrogen KWh 140 185 270 305
LN2 consumption kg 1610 2040 3460 4030
* Standard cycle
Technical Data
FREEZE-DRYING SOLUTIONS · 7
Base Values
Units FCM 200 FCM 400 FCM 600 FCM 800
Chamber
Surface finish µm 0,8 0,8 0,8 0,8
System leak rate mbar x l /s 0,008 0,008 0,008 0,008
Shelves
Flatness in the usable area mm / m 1 1 1 1
Surface finish on top side Ra µm 0,8 0,8 0,8 0,8
Surface finish on bottom side Ra µm 1,6 - 2,2 1,6 - 2,2 1,6 - 2,2 1,6 - 2,2
Temperature distribution on one shelf K < 1 < 1 < 1 < 1
Temperature distribution shelf stack K < 1,5 < 1,5 < 1,5 < 1,5
Difference between in- and outlet K <1 <1 <1 <1
Condenser
Inner surface of the condenser Finish Pearl blasted Pearl blasted Pearl blasted Pearl blasted
Surface finish of the condenser coils Finish Cold drawn Cold drawn Cold drawn Cold drawn
Defrosting of ice Min 40 50 60 60
Ratio evaporator area/shelf area m² / m² 1 1 1 1
Vacuum
Final vacuum of the vacuum pump set mbar 0.005 0.005 0.005 0.005
Final vacuum of the freeze dryer mbar 0.01 0.01 0.01 0.01
Pump time from 1000 to 0.1 mbar min 30 30 30 30
Cooling and Heating
Shelf cooling rate from +20 to -40°C K/min 1.5 1.5 1.5 1.5
Shelf heating rate K/min 1.5 1.5 1.5 1.5
Temperature range during drying °C -50 - + 60 -50 - + 60 -50 - + 60 -50 - + 60
Condenser cooling rate +20 to -40 K/min 1.5 1.5 1.5 1.5
Final temperature °C -75 -75 -75 -75
Performing Data
Sublimation rate kg/h 8.33 16.67 25 33.33
Turnaround (CIP, SIP, Drying, Recooling ) h 8 8.5 9 9
8 · FREEZE-DRYING SOLUTIONS
Chamber
Rectangular chamber •
Pressureless vessel •
Material 316 L •
Ports 3d •
Layout
1 Floor •
2 Floor •
Passthrough •
Door
Full size door •
Automatic locking •
Pizza door (constant loading level) •
Door in door •
Condenser Rectangular
Rear •
Side •
Underneath •
Hydraulic ram coverage with bellow •
CIP
CIP chamber + condenser •
Recirculation including heating •
Multiple cleaning media •
SIP
PED •
ASME •
GB-150 •
Chamber recooling after SIP •
Hydraulic
Lift / lower + stoppering •
Shelf Package
With rails and fully collapsible •
Hydraulic ram coverage with bellow •
Interface for ALUS® •
Refrigeration •
Piston compressors •
Screw compressors •
Liquid nitrogen •
Cascades (propene + ethylene) •
• Included • Option
Vacuum
Oil sealed vacuum pumps + blower •
Redundancy (second pump set) •
Dry pumps + blower •
Pressure Regulation
On/Off •
Flow controller •
Process Sensors
MKS •
Pirani •
Venting System incl. Filter
Sterilizable •
Ports for I-Test •
Second venting media •
Second venting filter •
Automatic WIT test •
Control System and Documentation
PLC Siemens •
PLC Rockwell automation •
SCADA - WIN CC •
iFix •
Recorder •
GAMP •
Audit trail •
21 CFR Part 11 •
FAT / SAT •
IQ/OQ Documents and tests •
Material certificates •
Welding documentation •
Technology
ALUS® •
ATEX (alcoholic solvent treatment) •
Cold shelf loading > +5°C •
Frozen shelf loading < +5°C - -40°C •
LYOPLUS® •
LYOSPARK® •
Automatic Loading and Unloading System
Loading •
Pusher with transfer table •
Vial handling •
Tray / nest handling •
Single row loading •
Multiple row loading •
Loading speed 200 V/min •
Loading speed 400 V/min •
Loading speed 600 V/min •
Loading on precooled shelves •
Transfer cart (automatic) •
Transfer cart (semi-automatic) •
Transfer cart (manual) •
Conveyor belts to the filling machine •
Containment
oRABS •
cRABS •
Isolator •
Unloading
Puller with transfer table •
Back pusher •
Vial handling •
Tray / nest handling •
Single row unloading •
Multiple row unloading •
Unloading speed 200 V/min •
Unloading speed 400 V/min •
Unloading speed 600 V/min •
Transfer cart (automatic) •
Transfer cart (semi-automatic) •
Transfer cart (manual) •
Conveyor belts to the capping machine •
Cleaning
Wipe down •
Wet cleaning with spray guns and static rots •
Inclination of the base plate •
Technology
LYODATA® •
LYOSENSE® •
ATEX •
Cold shelf loading > +5°C •
Frozen shelf loading < +5°C - -40°C •
Standard and Optional Features
Freeze Dryer
FREEZE-DRYING SOLUTIONS · 9
GEA Refrigeration for Freeze Dryers
GEA offers a variety of options for the implementation of
a freeze dryer refrigeration system, either mechanical or
cryogenic, which can be specifically adapted to individual
process and product requirements. The two main
considerations when selecting a suitable refrigeration
solution are refrigeration temperature and cooling capacity.
The lyophilizer refrigeration system from GEA cools the
freeze dryer shelves and condenser by chilling the heat
transfer fluids or directly expanding the refrigerants.
Cryogenic Cooling
Cryogenic refrigeration units offer constant cooling
capabilities throughout the entire ultra-low refrigeration
temperature range. Therefore, because of the correspondingly
high cooling requirements of the freeze-drying process,
a liquid nitrogen-based cooling system offers a number
of advantages — such as reduced electrical power and
maintenance needs — when working with extremely low
temperatures. For such a system, an easily accessible on-
site liquid nitrogen tank is an absolute prerequisite.
Mechanical Cooling
Mechanical compressor refrigeration is enabled with either
screw or reciprocating compressors. The two compressor
solutions differ in efficacy, efficiency, noise level and reliability.
The most appropriate option will depend on specific customer
requirements and is evaluated on a case by case basis.
If the use of natural refrigerants is required/favored or if a
cryogenic solution is not feasible, a two-stage compressor
cascade might be the best alternative. A compressor cascade
facilitates the large temperature differences and high
cooling capacities that are associated with cryogenic
refrigeration solutions.
Refrigerants
As mentioned above, GEA refrigeration units can operate with
either natural or synthetic refrigerants, depending on process
and product needs.
As conventional synthetic refrigerants are becoming less
common and increasingly more restrictive laws prohibit the use
of chemicals with a high global warming potential (according
to the Montreal and Kyoto Protocols), investing in a compressor
cascade for the use of natural refrigerants will become
increasingly cost-effective.
Cryogenic cooling skid including heat exchangers
and vacuum insulated piping
10 · FREEZE-DRYING SOLUTIONS
The LYOPLUS® mass spectrometer is a multipurpose measurement 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. Not only does
this help to define primary and secondary drying endpoints,
it reduces 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 owner 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, 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’s possible to
detect even small traces of silicone oil in situ. No additional
product is put at risk as the leak is detected immediately.
Moisture content (PAT)
At the start of the drying process, the chamber fills with product
derived vapor. 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.
System leak tests
To prevent leak-based contamination, it is mandatory to
perform a leak test after each critical process. Using LYOPLUS®,
it’s possible to reduce the time for this standard procedure
down from four hours, for example, 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: 1 ppm of
non-interfering species
Lyoplus® Monitoring for Lyophilization
FREEZE-DRYING SOLUTIONS · 13
Introducing ALUS®
GEA was the first manufacturers to develop ALUS® (Automatic Loading and Unloading Systems) technology using permanently installed systems (conveyor-pusher systems) and flexible transfer cart systems
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 size of isolators has made
it possible to decrease human intervention in
sterile areas and minimize contamination risks.
We 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.
Efficient, safe and reliable performance
ALUS® is designed to give the user the maximum
layout flexibility. This can include loading and
unloading from one side, loading and unloading
from two sides (pass through design), loading
with a push-pull system under isolator or RABS
systems, and unloading using a transfer cart with
RABS systems. ALUS® can also accommodate
a wide variety of filler and capper options, and
ATEX-compatible options are also available.
Stationary Push-Pull System: Implementing
the most appropriate ALUS® will depend on
the containment requirements and product-
related details. If it is necessary to have ALUS®
in conjunction with closed RABS (cRABS) or
isolators, then a fixed conveyor-pusher system
should be deployed. Not only ideal for use with
cRABS, it can also be placed within an isolator.
ALUS® Transfer Cart System: The latest ALUS®
Transfer Cart system takes the whole process further
by offering a flexible layout, a more compact design
and an advanced W-LAN panel-based control system.
It also facilitates docking under laminar flow, or in
an open RABS, and provides the ability to expand
the system by adding additional freeze dryers
when production demands increase. The mobile
transfer cart is particularly useful when charging
several freeze dryers. Formatting and loading can
run in parallel, thus optimizing the process.
Up to ten freeze dryers can be loaded and unloaded
by a single ALUS® transfer cart system (depending
on the application) so as a system grows the
additional production can easily be accommodated.
This is a much more flexible system than fixed
push-pull equipment and much more cost-effective.
The application of a unique gapless docking
technique – no gap between the freeze dryer
and transfer cart – means that we can guarantee
maximum product protection and ensure that vial
transfer occurs under a constant laminar flow.
FREEZE-DRYING SOLUTIONS · 15
ALUS® Automatic Loading and Unloading Systems
Both the Transfer Cart and stationary systems are
extremely adaptable with regard to primary packing and
the degree of automation (from manual to fully automatic
handling). They can also be retrofitted to existing units.
A high throughput rate of 500 vials/min. (loading)
and a maximum speed of 800 vials/min. (unloading)
can be achieved, with both the transfer cart system
as well as the stationary push-pull system.
The Transfer Cart system has been designed with flexibility in
mind and can be adapted to fit a wide range of floorplans and
layouts, even if the freeze dryer is not in line with the filler
or capper. Retrofit compatible, the cart can also be connected
to an existing freeze dryer or installed in new lines. Multiple
filling and capper lines can be accommodated as well.
Extremely efficient with short cycle times, the transfer cart
delivers high-end performance without needing a power rail
or battery. To ensure product protection throughout the entire
loading and unloading process, an induction-powered laminar
airflow guarantees constant and particle-free operation.
Able to move in six directions (right, left, up, down, forward
and backward) and use a variety of track systems, GEA’s transfer
carts meet the stringent requirements of the pharmaceutical
industry in terms of safety, hygiene and sterile design.
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.
The latest ALUS® equipment is up to 45% more compact
than its predecessors. This compact design significantly
reduces the footprint to keep building costs to a minimum
and allow much easier integration in retrofit applications.
The benefits of ALUS®
• 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 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® Buffer conveyor
16 · FREEZE-DRYING SOLUTIONS
Containment, Automation and Handling Options
Stationary Push-Pull System
Automation Manual Semi-automatic Fully automatic
Handling Frames Frames Trays
Trays Trays Vials
Vials Carpules
Open RABS • • •
Closed RABS • •
Isolator •
• Standard
Transfer Cart System
Automation Manual Semi-automatic Fully automatic
Handling Frames Frames Trays
Trays Trays Vials
Vials Carpules
Open RABS • • •
• Standard
Production Line with ALUS® Cross moveable Transfer Cart
FREEZE-DRYING SOLUTIONS · 17
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.
GEA LYOSENSE®
The lyophilization of pharmaceutical products such as vaccines
enhances their stability and shelf-life. However, these properties
can only be maintained when the resulting cake has a residual
water level of 0.2–5.0%.
For this reason, regulatory guidance indicates that this
parameter must be controlled and determined. Until now,
however, techniques to measure such properties have been both
destructive and time-consuming, and thereby uneconomical.
Real-Time Characterization of Lyophilized Products
LYOSENSE® from GEA, based on multipoint NIR measurements,
provides the comprehensive and non-destructive evaluation of
freeze dried product cakes in real-time. This easy-to-install and
use online measuring device is a fast and non-invasive solution
to moisture control, enabling the effortless detection of
• residual moisture
• cake homogeneity
• API concentration.
Other critical process parameters, such porosity, melt and glass
particles, can also be assessed.
For 100% vial inspection, machine communication capabilities
and easy integration into both lab and production environments,
this miniaturized probe is simple to calibrate and enhances
product development by facilitating Quality by Design.
Fully GMP and 21 CFR Part 11 compliant and supplied with
IQ/OQ/PQ support, the LYOSENSE® provides the following
benefits:
• whole cake assessment with multipoint measurement
• fast measurement and evaluation (5 ms)
• no required consumables
• simple and easy user interface and operation.
LYOSENSE® is compatible with other GEA innovations such as
LYODATA® for continuous monitoring and full traceability, and
the ALUS® automatic loading and unloading system.
ALUS® Bellow PusherLYOSENSE®
ALUS® Options
18 · FREEZE-DRYING SOLUTIONS
OFFERING SHORTER CYCLE TIMES, IMPROVED PRODUCTIVITY AND USING
STATE-OF-THE-ART MONITORING SYSTEMS, ALUS® REDUCES OPERATIONAL COSTS
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® bellows 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 bellows protected and, like
the backpusher, flat front and isolator containment is possible.
Starwheel
During freeze dryer loading, the ALUS® 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.
FREEZE-DRYING SOLUTIONS · 19
Total Vial Traceability
In collaboration with SCHOTT and HEUFT, GEA has developed
a vial traceability solution that will help the pharmaceutical
industry to implement the EU’s drug anticounterfeiting
directive, safeguard the rights of trademark and patent holders
and, ultimately, protect patients
The clock is ticking! The European Commission’s Directorate
General for Health and Food Safety will soon be implementing
the Falsified Medicines Directive. Pharmaceutical manufacturers
now have limited time to meet the requirements of the new
legislation and ensure the end-to-end verification of drug
authenticity.
Whether it’s a fad or the future, 100% vial traceability is
becoming an increasingly important consideration in the
pharmaceutical freeze drying industry. The current situation is
that traceability can only be done at batch level, which provides
very little information about the time, position or condition
(weight, for example) of a vial. Essentially, all vials are equal and
anonymous. The ideal situation is that “every vial has a name”
and can be individually tracked and traced.
Continuous Monitoring and Full Traceability: LYODATA®
A new type of system for the continuous traceability of primary
packaging, including complete process and product data backup,
could provide the ideal solution. LYODATA® provides unique
marking, clear identification and the consistent traceability of
pharmaceutical primary packaging, making drug counterfeiting
practically impossible. The system also offers continuous quality
inspection, 100% line clearance and precise sampling.
Ensuring distinctive and unmistakable marking and the 100%
traceability of pharmaceutical products in vials or containers
by laser coding and code verification, the system also includes
process and product monitoring data from primary packaging
production, grading and freeze drying, right up to the final
finished product!
Unique Marking and Clear Detection
SCHOTT technology is used to laser mark a 2D barcode onto
the glass vial or bottle during production. HEUFT’s innovative
all-round code verification system, which is fully compatible
with GEA’s Automatic Loading and Unloading System (ALUS®)
and suitable for oRABS, cRABS and isolator use, then checks the
(GS1) coding. Loading speeds of up to 500 vials per minute are
achievable, with each vial being subjected to a full examination
both before and after lyophilization.
With the ultimate aim of guaranteeing a unique identification
code for each sample, tracking it during the freeze drying
process, having real-time access to the data and vials in process
and to be able to document that data for customer use, GEA has
made a commitment to 100% vial traceability. This not only
prevents drug counterfeiting and protects intellectual property,
it also helps to uphold the health of the patient.
“The pharmaceutical and biotech industry has long been
looking for a solution,” says GEA’s Johannes Selch, adding:
“Manufacturers needed to progress from a batch-based system
to achieve precise vial control and traceability during the entire
sterile production process. Now, there’s no more hide and seek,
any vial can be located at any time or process step. It’s a simple
case of 10,000 vials in and 10,000 vials out.”
Whether it’s a fad or the future, 100% vial
traceability is becoming an increasingly
important consideration in the
pharmaceutical freeze-drying industry
20 · FREEZE-DRYING SOLUTIONS
GEA Service – For your continued success
GEA’s unique service program and retrofit concept ensures
an optimized return on investment throughout the lifetime
of the plant. To guarantee optimum performance and operational
excellence, we provide a wide range of services to maintain and
improve your plant and equipment.
Getting you started: seamless support for instant
productivity and performance
From installation onwards, our GEA Service teams will work
with you to get the best out of your plant and equipment. As a
supportive and committed partner for life, we start as we mean
to go on.
We plan and build according to individual needs, sharing
process knowledge, training staff and supporting operators to
get you up and running and deliver a smooth, seamless and
ongoing service for optimum performance and safety.
Keeping it running: the cost-efficient way to ensure
safety and reliability
Regular maintenance is not a cost, it’s an investment. By
implementing corrective and preventive maintenance techniques,
we ensure high performance, availability and quality — as well as
maximizing the lifecycle of your equipment or plant.
To ensure you benefit from continuous production and minimal
downtime, we provide fast support and top quality spare parts,
whenever and wherever they’re needed.
Constantly improving: sharing our knowledge to
safeguard your investment
To meet your production requirements — today and tomorrow
— GEA works with you to keep your equipment up to date
and optimized.
We safeguard your investments by constantly looking ahead, by
upgrading or modernizing equipment and enhancing processes
to meet changing needs and new market demands. We are
always working to increase production efficiency and ensure
peak performance.
Together with you: enduring commitment to you and
your business
By integrating the latest automation and control solutions, we
boost your output and efficiency, reduce waste and minimize
both resource use and the need for manual intervention.
Our commitment to you and your business means investing
in your objectives, your risks and your future success. We
collaborate with you to provide ongoing systems audits and
on-site support, and to generate improved performance through
innovative new service models.
22 · FREEZE-DRYING SOLUTIONS
FOR BETTER BUSINESS SUCCESSGEA Service partners with our pharma and biotech customers,
supporting them throughout the entire lifecycle of their plant
and equipment to ensure business success.
GEA’s retrofit concept ensures an optimized return on investment
FREEZE-DRYING SOLUTIONS · 23
GEA Lyophil GmbH
Kalscheurener Straße 92
50354 Hürth, Germany Tel +49 (0) 2233 6999 0 gea.com/contact © G
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GEA is one of the largest technology suppliers for food processing and a wide range of other industries. The global group
specializes in machinery, plants, as well as process technology and components. GEA provides sustainable solutions for
sophisticated production processes in diverse end-user markets and off ers a comprehensive service portfolio.
The company is listed on the German MDAX (G1A, WKN 660 200), the STOXX® Europe 600 Index and selected MSCI
Global Sustainability Indexes.
We live our values.Excellence • Passion • Integrity • Responsibility • GEA-versity