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  • Freeze-Drying SolutionsPharmaceutical lyophilization technology

  • 2 · FREEZE-DRYING SOLUTIONS

  • 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

  • FREEZE-DRYING SOLUTIONS · 5

  • 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 25 FCM 75 FCM 200 FCM 400 FCM 600 FCM 800

    Chamber

    Geometry Form Rectangular Rectangular Rectangular Rectangular Rectangular Rectangular

    Shelves

    Shelf area m² 1,6 4,7 10 20,4 30,2 41,22

    No. of shelves Quantity 5 + 1 5 + 1 9 + 1 11 + 1 13 + 1 15+1

    Shelf size mm 350 x 900 700 x 1350 914 x 1219 1219 x 1524 1524 x 1524 1524 x 1803

    Clearance mm 125 125 125 125 125 125

    No. of vials (Ø 16mm) Batch size 3260 20,035 42,759 87,527 129,662 177,000

    No. of vials (Ø 22mm) Batch size 1,690 10,505 22,464 46,057 68,302 93,240

    No. of vials (Ø 30mm) Batch size 885 5,580 11,970 24,607 36,530 49,875

    Shelf temperature °C -55 … +70 -55 … +70 -55 … +70 -55 … +70 -55 … +70 -55 … +70

    Condenser

    Geometry Form Rectangular Rectangular Cylindrical Cylindrical Cylindrical Cylindrical

    Position Underneath Underneath Laterally / behind Laterally / behind Laterally / behind Laterally / behind

    Type Tube Tube Tube Tube Tube Tube

    Nominal ice capacity kg 25 75 200 400 600 800

    Chamber \ Condenser Valve

    Type Plate Plate Mushroom Mushroom Mushroom Mushroom

    Clear diameter mm 350 x 900 700 x 1350 500 700 900 1000

    Weights

    Chamber and condenser (empty) t 7.5 9 12.5 15 17.5 20

    Utility Consumption

    Units FCM 25 FCM 75 FCM 200 FCM 400 FCM 600 FCM 800

    Utilities

    Pure steam barg 1,5 1,5 1,5 1,5 1,5 1,5

    °C 127 127 127 127 127 127

    Consumption for sterilization* kg 65 145 240 385 460 560

    Consumption for defrosting kg 10 35 80 110 240 320

    CIP water barg 3-4 3-4 3-4 3-4 3-4 3-4

    Temperature °C 80 80 80 80 80 80

    Consumption* m3 1 1,8 2,6 3,4 4,2 5

    Cooling water (Compressor) °C < 25 < 25 < 25 < 25 < 25 < 25

    Peak flow m3/h 3 5 9 12 15 19

    Consumption* m3 24 65 138 175 212 267

    Electrical power supply kW 35 70 105 140 175 210

    Power Consumption per Cycle*

    With compressors KWh 150 380 650 900 1250 1700

    With liquid nitrogen KWh 85 100 140 185 270 305

    LN2 consumption kg 590 850 1610 2040 3460 4030

    * Standard cycle

    Technical Data

    FREEZE-DRYING SOLUTIONS · 7

  • Base Values

    Units FCM 25 FCM 75 FCM 200 FCM 400 FCM 600 FCM 800

    Chamber

    Surface finish µm 0,8 0,8 0,8 0,8 0,8 0,8

    System leak rate mbar x l /s 0,008 0,008 0,008 0,008 0,008 0,008

    Shelves

    Flatness in the usable area mm / m 1 1 1 1 1 1

    Surface finish on top side Ra µm 0,8 0,8 0,8 0,8 0,8 0,8

    Surface finish on bottom side Ra µm 0,8 - 1,4 0,8 - 1,4 0,8 - 1,4 0,8 - 1,4 0,8 - 1,4 0,8 - 1,4

    Temperature distribution on one shelf K < 1 < 1 < 1 < 1 < 1 < 1

    Temperature distribution shelf stack K < 1,5 < 1,5 < 1,5 < 1,5 < 1,5 < 1,5

    Difference between in- and outlet K

  • 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

  • FREEZE-DRYING SOLUTIONS · 11

    Condenser of LYOVAC® Freeze Dryer

  • 12 · 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

  • 14 · FREEZE-DRYING SOLUTIONS

  • 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.

    INTEGRATED FREEZE-DRYING SOLUTIONS · 15FREEZE-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

  • 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

  • FREEZE-DRYING SOLUTIONS · 21

  • 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 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 gea.com/contact © G

    EA G

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    GEA is a global technology company with multi-billion euro sales operations in more than 50 countries. Founded in

    1881 the company is one of the largest providers of innovative equipment and process technology. GEA is listed in the

    STOXX® Europe 600 Index. In addition, the company is included in selected MSCI Global Sustainability Indexes.