Freeze-Drying Solutions - GEA engineering for a …...Freeze Drying Essentials Freeze drying...

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Freeze-Drying Solutions Pharmaceutical lyophilization technology

Transcript of Freeze-Drying Solutions - GEA engineering for a …...Freeze Drying Essentials Freeze drying...

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Freeze-Drying SolutionsPharmaceutical lyophilization technology

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2 · FREEZE-DRYING SOLUTIONS

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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

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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.

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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

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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

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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 <1 <1 <1 <1 <1 <1

Condenser

Inner surface of the condenser Finish Pearl blasted Pearl blasted Pearl blasted Pearl blasted Pearl blasted Pearl blasted

Surface finish of the condenser coils Finish Cold drawn Cold drawn Cold drawn Cold drawn Cold drawn Cold drawn

Defrosting of ice Min 20 30 40 50 60 60

Ratio evaporator area/shelf area m² / m² 1 1 1 1 1 1

Vacuum

Final vacuum of the vacuum pump set mbar 0.005 0.005 0.005 0.005 0.005 0.005

Final vacuum of the freeze dryer mbar 0.01 0.01 0.01 0.01 0.01 0.01

Pump time from 1000 to 0.1 mbar min 30 30 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 1.5 1.5

Shelf heating rate K/min 1.5 1.5 1.5 1.5 1.5 1.5

Temperature range during drying °C -50 - + 60 -50 - + 60 -50 - + 60 -50 - + 60 -50 - + 60 -50 - + 60

Condenser cooling rate +20 to -40 K/min 1.5 1.5 1.5 1.5 1.5 1.5

Final temperature °C -75 -75 -75 -75 -75 -75

Performing Data

Sublimation rate kg/h 1.04 3.13 8.33 16.67 25 33.33

Turnaround (CIP, SIP, Drying, Recooling ) h 7 7.5 8 8.5 9 9

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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

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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

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FREEZE-DRYING SOLUTIONS · 11

Condenser of LYOVAC® Freeze Dryer

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12 · FREEZE-DRYING SOLUTIONS

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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

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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.

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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

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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

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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

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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.

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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

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FREEZE-DRYING SOLUTIONS · 21

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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.

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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

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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

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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.