GEA Pharma Systems

GEA Pharma Systems
Small Scale Solid Dosage R&D
A complete range of technologies especially for use in R&D facilities
engineering for a better world
GEA Pharma Systems supplies advanced technologies for the preparation
and processing of Active Pharmaceutical Ingredients (API) for the
production of oral and parenteral dosage forms.
GEA Pharma Systems strives for Price/Performance Leadership providing
its customers with highly cost effective, integrated systems for the
pharmaceutical industry. GEA Pharma Systems is dedicated to innovation
and thereby providing durable quality through its well-established brands:
Aeromatic-Fielder™ and Collette™ - batch and continuous granulation,
drying, pelletizing and coating; Buck® -contained materials handling;
Courtoy™ – tablet compression; Lyophil™ - pharmaceutical freeze drying
and automated vial handling systems; and Diessel™ - fermentation and
liquid formulation.
GEA Pharma Systems’ activities include partnering with customers to
develop new products and enhance clinical effectiveness; the supply of
R&D-scale and stand-alone production equipment; and the installation of
complete integrated production lines aiming at maximum operational
reliability.
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Partner in R&D
Specifically Designed R&D equipment
Our R&D range spans all aspects of oral solid dosage production from high
shear mixers, fluid beds and single pot systems to extruders and
spheronizers, blenders and containment solutions, right through to R&D
tablet compression.
GEA Pharma Systems has a complete range of equipment especially for use
in R&D facilities. The equipment is designed for specific applications
taking into account, right from the start, the often limited space available
for their installation.
Innovation is as important for you as it is for any other business
Innovation is the key to GEA Pharma Systems’ success and to the
continued prosperity of its customers. In fact it’s much more than that. We
know that by continually stretching the boundaries of what is possible in
pharmaceutical processing we have the ability to support our customers in
enhancing the opportunities available to millions of people all over the
world. This is what drives our business. Our innovation takes many forms
and affects all parts of the process. We innovate to increase production and
reduce costs, to improve containment and safeguard the workforce, to
achieve better clinical effectiveness and to enhance quality control.
At GEA Pharma Systems innovation never stops – it’s just part of what we do.
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PharmaConnect™ Processing
The centre of the GEA Pharma Systems’ small
scale and R&D approach is PharmaConnect™.
This innovative system provides a unique
benefit to the Pharmaceutical Development
industry, integrating a single Control Unit
with a diverse range of Process Modules.
Based upon GEA Pharma Systems’ class-leading
PMA and Gral granulation technologies, the
PharmaConnect™ provides the user with the ability
to process batches from as little as 100g, right up to
25kg or more, all from a single control system.
However the PharmaConnect™ is not limited to just
granulation; the unique design of the Control Unit
allows any number of process technologies to be
operated from the single Operator Interface.
The key technologies offered include:
• PMA™ - Bottom Driven High Shear Granulation.
• Gral™ - Top-Driven High Shear Granulation.
• Nica™ - Extrusion and Spheronization.
• Buck™ – IBC Blending Systems and Containment.
• TRV – High Shear Blending.
Each of these technologies is class-leading.
PharmaConnect™ provides the opportunity
to try them all.
PMA working volumes / batch size
Control Unit
At the centre of the PharmaConnect™ technology is
Equipment
Type
Equipment
Size
the Control Unit. Available in Through-the-Wall
(TTW) or Mobile format. The unit features GEA’s
Module Recognition System (MRS), Touchscreen
Development
User Interface and one of the module drive systems.
The MRS senses the type and capacity of the
connected module, seamlessly displaying an image
operational set points and defining the parameters
for the busy Formulation Scientist!
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1
3
240g
720g
450g
1.35kg
5
1.2kg
2.25kg
10
15
2.4kg
3.6kg
4.5kg
6.75kg
20
30
60
4.8kg
7.2kg
14.4kg
9kg
13.5kg
27kg
Intermediate
of the process on-screen, enabling the correct
for the electric motors. A true Plug and Play system
Typical
Typical
Minimum
Maximum
[email protected] [email protected]
Pilot
Granulation, Blending & Pelletizing
TRV - High Shear Blending
Turbo Rapid machines have a history of over
40 years providing a high intensity blending regime for
dry powders. Homogeneity and stability are key factors
in the production of inhalable drugs and due to the
unique TRV impeller blade and high operating speed,
the TRV delivers in both areas. Available with working
capacities from as little as 150g, and up to 30kg, the
TRV can be specified in standalone or in
PharmaConnect™ Formats.
PMA™ - Bottom-Driven High Shear Granulation
Granulation is at the heart of the PharmaConnect™
system and the range of capacities that can be
processed is truly unique. Standard module capacities
for the bottom-driven PMA are set at 1, 3, 5, 10, 15, 20,
30 and 60 litres with each unit being geometrically
scaleable. Critically, each of these modules features its
own impeller drive motor, maintaining a consistent
energy input per unit volume. By providing this level of
flexibility, the development scientist operating at the 1litre level can provide true scale-up data for commercial
expansion.
Gral™ - Top-Driven High Shear Granulation
As the state-of-the-art, top driven granulation system,
the Gral is renowned worldwide for its high quality and
robust design. Scaleability is the key to the system’s
success.The UltimaGralTM starts from a 10 litre bowl,
with further scale-up provided with 25 and 75 litre
capacities. From these sizes, scale-up to production
equipment is easy. Furthermore the system may be
integrated to the PharmaConnect™ Control Unit,
providing complete process flexibility.
Buck® – IBC Blending Systems
Nica™ IPS-5 Extrusion and Spheronization
Designed to handle a complete range of laboratory-
As the only pelletization system developed solely for
sized IBCs from 3 litres to 715 litres, utilising a single
the Pharmaceutical Industry the Nica™ IPS-5 extruder
process module. All IBC sizes feature the removable
and spheronizer represent perfect partners for the
Blending Prism™ technology unique to GEA Pharma
PharmaConnect™. Offering the capability to pelletize
Systems. Furthermore, NIR technology can be applied
batches of as little as 50g, but still maintaining the
to provide online detection of the blend homogeneity.
operating principals of the larger pilot and production
The Prism™adds low shear mixing to the rotating IBC,
machines, the PharmaConnect™ Nica™ IPS-5 is the
adding to the turbulence of the tumbling product and
perfect development tools.
improving the time to homogeneously blend products.
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Contained Processing
A complete system for small-scale production, the plant delivers a one-stop
solution to take raw materials through to tableting and includes:
-
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High Shear Granulation (PMA™)
Pelletization (NICA™)
Drying (Aeromatic-Fielder™)
Pellet Coating (FlexStream™)
Blending (Buck Systems™)
Furthermore, by utilising GEA Pharma Systems’ inspired containment
technologies, a total solution may be tailored to suit each user’s specific
requirements whether through integration of process or by loading and
discharge via rigid split valve (Buck® MC Valve) or disposable split valve
(Hicoflex®) solutions.
Totally Contained, Completely Flexible
High Shear Granulators
The Aeromatic-Fielder™ & Collette™ High Shear Mixer and
Granulator are multi-purpose processors equally suitable for
high speed dispersion of dry powders, aqueous or solvent
granulations, effervescent production and melt pelletization.
PharmaConnect™ which enables diverse GEA development
equipment to be docked into a single ‘plug and play’ module
with full cGMP compliance.
Process Overview
At the heart of the production plant are PharmaConnect® and
Flexstream™. PharmaConnect® is GEA’s innovative, modular
granulation and blending system offering an unbeatable range
of process types and capacities; FlexStream™ is the world
leading process technology for spray granulation and pellet
coating, delivering unbeatable benefits in terms of greater
productivity, lower running costs and a robust and scaleable
process.
Containment Valves & Disposable
Containment Interfaces
The system includes examples of both rigid and disposable
product transfer technology offering containment down to low
nanogram levels. These options include: the disposable
Hicoflex® system with significantly lower capital and running
costs compared with rigid IBC technology and rapid product
changeover for improved plant utilization; the unique, modular
Buck® MC valve with its simple design that enables complete
container-to-container transfer flexibility; and the Buck® TC
Valve, the highest performing split valve available in the market
place. By introducing a wash step prior to valve separation, the
Buck® TC Valve is capable of performance to the low nanogram
level.
Integrated Approach
All of these technologies are brought together for an integrated
process system that mimics the hundreds of large-scale plants
provided by GEA Pharma Systems globally. It epitomises the
approach of ensuring customers receive the same technology
from the laboratory through to production, using the same
containment and process technologies to ensure seamless scaleup and the most flexible blend of process capabilities.
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Fluid Bed Processing
For fifty years, GEA Pharma Systems has supplied advanced solids
processing plants for blending, granulating, drying, pelletizing and coating
to the pharmaceutical industry. This includes small capacity systems
designed for R&D as well as industrial size plants for batch production of
pharmaceutical compounds under cGMP conditions.
Our plant and process expertise is based on experience and R&D. With plants
installed around the world and literally thousands of tests performed, we have
established a solid base of expertise related to the needs of the pharmaceutical
manufacturing industry. Emphasizing the importance of R&D, GPS offers 3
complementary dedicated units that fit perfectly into the laboratory environment,
offering batch sizes from as little as 50g, up to over 6kg.
MP-Micro™
STREA-1™
Optimize the formulation and identify the process
Combining versatility with table-top practicality, the
parameters to establish the desired product
Strea-1™ is one of the most recognisable process
characteristics. Test small quantities of rare and
machines in the pharmaceutical industry. Purpose
expensive materials before decisions are taken on
designed for processing of fine powders, pellets,
whether it’s viable to proceed with the next stage of
granules, crystals and tablets, the STREA-1™ is the
product development.
flexible choice when taking the first steps towards
process optimisation.
Purpose-designed for R&D projects, the MPMICRO™ Fluid Bed brings all the flexibility of a
Product drying, top spray granulating and coating –
full-size production fluid bed to the laboratory
in volumes ranging from 200ml to two litres – can
bench-top.
all be handled by the STREA-1™, thanks to its
interchangeable components and containers.
Main features
Continuing GPS’s strong commitment to research
• Variable process control of airflow, temperature
and development and high quality standards, the
and liquid addition.
• Interchangeable product containers.
• Filter blow-back system.
• Easy strip down for cleaning.
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STREA-1™ is a vital addition to the laboratory
bench-top.
Granulation, Drying, Pelletizing & Coating
Multi-Processor™ MP-1
For true process flexibility and as an
introduction to production scale processing,
the MP-1 is the machine of choice.
Capable of performing any Fluid Bed Process, the
MP-1 features a diverse range of options including
high efficiency drying, top spray granulation,
bottom spray pellet coating (Precision Coater™) and
side spray granulation / coating (FlexStream™).
With a batch range from as little as 500g, up to over
6.0kg, the MP-1 complements the GPS granulation
and pelletization equipment, but still maintains the
flexibility offered by a mobile design.
To provide more scale-up capability, GPS can also
offer the MP-1-size product container as an option
on its pilot size 2 equipment. This expands the range
of the MP-2 to allow drying of batches from 1kg up
to 25kg in a Through-the-Wall, GMP design.
FlexStream™ the ultimate in fluid bed
flexibility that offers granulation, drying and
coating in a single processor with built in
linear scale-up. The FlexStream™ concept
requires no mechanical adjustment when
switching between the drying, granulating and
coating modes.
MP-Micro™
Strea-1™
MP-1
MP-2
50-200g
100g—1kg
500g - 5kg
1kg—25kg
Drying
•
•
•
•
Top Spray Granulation
•
•
•
•
Top Spray Pellet Coating
•
•
•
•
Precision Coating™
Bottom Spray Pellet Coating
•
•
•
•
FlexStream™ Granulation
Side Spray Granulation
•
•
FlexStream™ Coating
Side Spray Pellet/Tablet Coating
•
•
Typical Capacity
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Single-Pot Processing
Single-Pot Technology offers a choice of mixing, granulation
and drying options integrated into one processing vessel.
For development purposes, the Collette™ UltimaPro™ 10 and 25
has the processing batches capacities of 1 to 9kg. All key
characteristics, granulation and drying options of the Single-Pot
Processor are available for these R&D machines. Both are compact,
mobile machines which are easy
to install because of a Plug & Play concept.
Compact and Cost-Effective Processing
Single-Pot technology is a very compact technology achieved by
incorporating several processing steps into one machine. This
reduces the capital cost of the equipment as well as the cGMP &
technical space required for granule production and
therefore the overall project cost.
Flexible Processing
UltimaPro™ combines high-shear
Whether for standard wet granulation, melt granulation,
granulation with highly efficient vacuum
pelletizing or effervescent production, combined with vacuum or
and microwave drying technologies.
microwave drying, a single-pot processor can achieve the required
The result: the ultimate flexibility for both
result. The swinging bowl option enhances this flexibility even
pharmaceutical R&D and production.
further by its capability to process older formulations to a high
Single Pot Processing - ideal for:
quality standard. With easy and efficient cleaning, using a CIP
system, quick product changeover is achievable.
- Ecological, organic solvent-based solid
dosage processing: UltimaPro™-Eco
- Efficient processing of effervescent
formulations (especially water-based
reaction method): UltimaPro™-FZ
- High containment solid dosage processing
for oncology, hormone and other highly
potent products: UltimaPro™-HC
Contained Processing
Because of its very nature, a single-pot process is a contained
process. No transfers are required between process steps, except
for loading the raw materials and unloading the dry granules. This
is not only beneficial for protecting the operators from potent
products, but also for protecting the products from external
influences such as heat, light or moisture. Specific solutions are
available for product loading and discharging to achieve the
desired level of containment for the whole process
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Continous processing
ConsiGma™ 1 : our blue sky
approach from powder to tablet
Inspired lab-scale continuous processing for fast, easy
R&D. Revolutionise the way you develop and
produce tablets
ConsiGma™ is an innovative high-shear granulation and
drying concept capable of producing pharmaceutical
granules continuously, without start-up and shut-down
waste. This concept enabled the use of the same system for
development and production work without the need for
scale-up, as the determining factor for batch size is running
time – not the size of the equipment. Batch sizes ranging
from a couple of kilogrammes up to several tonnes could be
produced.
In early research and formulation development however, the
availability of the active ingredient is often very limited and
there is a need for process equipment that is capable of
producing only a couple of hundred grams to develop new
drug formulas.
In response to this need, GEA Pharma Systems developed
ConsiGma™-1, the lab-scale version of the ConsiGma™
concept. This system consists of a patented continuous high
shear granulator equipped with all necessary auxiliaries to
allow the development of the granulation process. A small
dryer equal to one drying segment of the ConsiGma™
production dryer and capable of handling 0.5 to 1.5kg of
granules, can be added to the lab machine, creating a unique
combination with integrated controls for the development of
continuous processes.
ConsiGma™-1 is capable of running batches of a couple of
hundred grams up to 5 kg (or more if necessary), with less
than 10 g of product held up in the process and less than 80
g of product losses. Because of the fast processing times,
minimal retention times and flexibility of the system, it is
ideal for developing the formula and process parameters
using Design of Experiments. The process parameters
developed with ConsiGma™-1 can be directly transferred to
the full ConsiGma™ system.
The system is designed for fast and
easy deployment in R&D labs.
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Nica™ Pellet Processing
Modular concept
The unique modular concept of the Nica™ Pelletizing
System facilitates optimized solutions to meet process
needs exactly.
Mixer / granulator, extruder and spheronizer modules are
combined to create a complete integrated pellet production
plant, or selected individually to suit specific requirements.
Modules can be operated in either batch or continuous mode,
for maximum flexibility of operation, and can be used standalone, or integrated with other up- or down-stream equipment
such as fluid bed processing systems.
Ideal for both product development and full-scale production
applications, process scale-up of the Nica™ Pelletizing System
is easy – it’s simply a factor of processing time.
Nica™ Extruder
Nica™ Spheronizer
The Nica™ Extruder is based on unique low-shear technology
The Nica™ Spheronizer features a smooth-edged, close-fitting
designed to minimise work input and temperature rise. It is
friction wheel for good sphericity of pellets and a tight pellet
ideal for sensitive products which could be damaged by more
size distribution. This patented design eliminates problems of
intensive systems. A wide range of extrusion screen sizes and
edge-milling and undesirable fines common with traditional
configurations are offered for optimisation of pellet diameter,
technology. Optimisation of the process is achieved by choice of
surface quality and size distribution.
cycle time, wheel speed, product loading, friction pattern and
regulation of air-flow past the wheel periphery.
Used for both batch and continuous production, the Nica™
Extruder has no stagnant areas, and no significant product
The Nica™ Spheronizer is fed directly by the Nica™ Extruder.
hold-up. A compact design eases installation and cleaning.
For high volume applications, two batch spheronizers may be
fed by a single continuous extruder.
With a simple reconfiguration
of the extruder, formulations
• Good pellet sphericity
that require a high
• Produces no fines
degree of work input
• Versatile system
can be
• Easy to operate
processed.
• Easy to clean
• Efficient low-shear
technology
• Wide choice of
extrusion screens
• Gentle on product
• Small foot-print
Extrusion
Typical Production Rate
Minimum Batch Size
E-Connect
E-140
0.1—0.5 kg/min
0.5-2.0 kg/min
50g
200g
• Easy to clean
Spheronizing
Typical Batch Range
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S-Connect
S-320
S-450
50g—250g
200g –1.0kg
400g—2.0kg
Integrated Ease
Building upon GEA’s renowned integrated granulation
systems, Nica is now available in three fully equipped
pelletization systems.
Based on the ground-breaking PharmaConnect technology, the
IPS5 provides the user with a true mini-production machine for
the development environment. Providing batch capacities from
less than 50g, the user is now able to test expensive, rare
molecules with formulations and equipment that mimic those
found in the production environment.
For small pilot batches of 250g to continuous production at over
25kg/hr, the IPS25 links the E140 and S450 technologies in an
integrated system. Operating in manual mode, the user controls
the dosing of the extrudate into the spheronizer and the overall
spheronization time. With a developed recipe, these timings are
automated to ensure product consistency from the first to the
final pellet.
Further complementing the IPS range, the IPS100 integrates the
E220 and S700 technologies scaling 100kg/hr production rates
from the first principles developed on the IPS5.
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Tablet Production
PERFORMA™ P
Featuring the innovative Exchangeable Die Disc (EDD), is a
flexible tablet press for small to medium scale production.
On the PERFORMA™ P, the entire turret, including punches and dies, can be easily
removed from the machine and replaced with a duplicate turret in less than 30 minutes.
Alternatively, the turret removal arm can be used to lift and swing out the upper punch
guide part of the turret only, clearing the way for the light-weight EDD holding the dies
to be taken out manually. The EDD can then be replaced by a duplicate Die Disc, with
the entire exchange procedure taking less than 30 minutes.
The PERFORMA™ P is now available with a bilayer kit, which quickly transforms the standard
machine making it capable of both single- and
The EDD offers additional benefits compared to the
exchangeable turret:
• Fast and easy format change over: duplicate EDD allows off-line fitting
and locking of the dies in the Die Disc.
• More economical alternative to the exchangeable turret: only the Die Disc
needs to be duplicated, instead of the entire turret.
In addition to the exchangeable turret and the EDD, the PERFORMA™ P
features a swivelling tablet chute enabling fast turret removal and ejection
set-up.
An optional easy-to-install kit enables effortless conversion of the
PERFORMA™ P from single-layer to bi-layer machine.
The PERFORMA™ P is available with the latest Courtoy™ developments
in process control:
• 6 different compression modes, including equal porosity tableting (EPT).
EPT is the ideal compression method for novel solid dosage forms, such
as ODT and MUPS.
• Adjustable dwell time at pre-compression, for improved de-aeration of
the powder bed and optimal particle rearrangement prior to the main
compression effort.
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bi-layer production. The bi-layer kit consists of
only a few components, which are very quick
and easy to install.
By adding this new asset to the many benefits of
its advanced compression technology, GEA
Pharma Systems - Courtoy™ has further
enhanced the flexibility of its machine range.
Small-Scale and Versatile
MODUL™ P
The small-scale tablet press is the most versatile and powerful
tablet compression machine for development work and clinical
trial production.
Various methods of tablet compression and process control:
• 6 different compression modes are available on the MODUL™ P.
• The ‘equal porosity compression’ method is ideal for novel solid dosage
forms, such as ODT, MUPS, etc.
• The force versus time compression profile is fully controllable and, once
set up, is kept constant irrespective of machine speed.
Full flexibility for tooling types:
• The turret can be equipped with a customised and mixed number of D, B
and BB punch positions.
• The most common configuration for formulation development and
research purposes is a turret with 10 B and 10 D punch positions. Blank
dies are supplied to blank off unused positions.
Special features for small powder quantities (down to 1kg)
• Special ‘low-volume’ powder feeder with slide-in wear plate to
minimise powder losses.
• The machine can work with just one punch.
• The dust extraction can be switched off.
Different ECMs (Exchangeable Compression Module) can be used
in the same basic machine with one and the same control system:
• C-ECM (contained ECM) for non-potent products.
• WOL-ECM (wash-off-line ECM) for potent/toxic products.
• BL-ECM (bi-layer ECM) for bi-layer tablet production
(up to 100.000 tab/hour).
All ECMs offer unmatched operator protection and
extremely fast product change-over.
The highly sophisticated CDAAS (Courtoy Data Acquisition and Analysis System)
measures and samples the following signals at high frequency:
• Pre-compression force
• Main compression force
• Ejection force (optional)
• Pre-compression displacement
• Main compression displacement
• Punch stroke (optional)
A large number of advanced signal analysis functionalities are included, such as automatic
calculation of the compression energy exerted on and absorbed by the tablets and Heckel plots.
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Contained Product Transfer
MC Valve for rigid transport containers
For over 10 years, Buck® has supplied dust- and contaminationfree containment interfaces for the safe transfer of powders,
particulates and tablets in the pharmaceutical industry.
These interfaces ensure the protection of both people and
products when charging and discharging high-potent APIs.
The Buck® MC Valve concept unifies all the current
requirements in high containment equipment: full GMP design,
no need for lubrication, no need for vacuum, robust centering,
free orientated docking, quick release without any tools as
standard.
But the most innovative step is the idea of using only passive
valves driven by a modular actuator unit.
1. undocked, unlocked & closed
2. docked, locked & closed
3. docked, locked & opened
Specifications
Suitability
Features
Options
powders, granules, pellets, tablets
100% FDA conformity
anti-static seal material available
product contacting materials: AISI 316L
specialities available on demand
All product contacting parts are available in
hastelloy or coated version
Benefits
Cost saving
Safety
Flexibility
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Buck® Valve TC
Buck® Valve MC
Buck® Valve UHC
Buck® Valve MC
Buck® Valve HC
Buck® Valve MC
cost efficient, tailor made solution
low maintenance
Buck® Valve MC Interface
<0,1
0,1-1
1-10
Hicoflex® extra
Hicoflex® SL
10-100
>100
high operator and product protection
direct IBC to IBC transfer
very few tubing and cabling (no vacuum
required, integrated locking)
quick release as standard
Containment Levels:
Short Term Exposure ST TWA [mcg/m3]
Disposable Materials Handling
Hicoflex®, the first time in the industry the benefits of bags have been
combined with split valve containment performance! Its simple yet
effective design provides levels of containment normally associated with
expensive and complicated split butterfly valves.
Clear and flexible bags allow users to physically agitate product flow and
visually confirm full product transfer. Providing 100% yield on material
transfers without putting operators safety at risk with poor levels of
containment. Equipment no longer needs to sit unused while you wait for
the process areas to be cleaned.
Hicoflex® products
Hicoflex® Charge Bag
Fully-contained powder transfer
bag for contamination-free
charge/discharge of hazardous
materials.
Hicoflex® Adaptor
Process equipment adaptor that
fits all Hicoflex® bags.
Tri-clamp size: 2”, 4”, 6”
Hicoflex® Spray Bag
Unit to rinse the internal
surfaces of the adaptor before
removal to ensure full operator
protection.
Throw Away Your Cleaning Concerns
• Zero risk of cross contamination.
• No expensive wash media & detergent needed.
• No effluent treatment required.
Hicoflex® Sample Bag
• No expensive swab testing.
Fully-contained sampling
device for sampling the process
through an adaptor or bulk
material out of a Hicoflex®
charge bag.
Sampling volume: 1/5/10 ml
• Keep your operators free to do the jobs you pay them to do.
Disposable Containment enables your operators to perform the
jobs they should be doing, not changing in & out of air suits,
not washing small fiddly containers and not waiting for cleaning
validation.
Hicoflex® gives you the power to work more effectively and
efficiently. Reducing over-heads and running costs while improving
yield and output, means you get your product faster to the market.
Hicoflex® Charge Bag plus
Hicoflex® charge bag equipped
with an internal rinsing device
to ensure a full yield discharge.
Safer, Flexible and more Cost Effective!
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GEA Pharma Systems Technology Centres
With the GPS Technology Centres, GEA Pharma Systems takes
customer partnership and R&D to new levels. Our centres
offer a complete range of R&D and product testing services,
where customers can test and optimise existing processes,
develop new procedures, and perform pilot scale productions
of any aqueous or solvent based pharmaceutical product. Our
customers can perform comparative process studies with our
skilled operators by testing complete process trains. All
processing is optimized by utilising advanced CIP technology.
Furthermore, our centres have full demonstration and training
facilities making GEA Pharma Systems your obvious choice
for a pharmaceutical process partner.
The GPS Technology Centre (GPS TC) in Bubendorf,
Switzerland supports pharmaceutical companies to bring new
products to market quickly, effectively and with easy scale-up
to full production. The Centre is equipped with a full range of
GPS batch solid dosage processes including: contained
materials handling, dispensing, blending and powder mixing,
granulation and drying, extrusion, spheronization,
pelletization, tablet production and coating.
Batch Processes
GEA Pharma Systems is in the unique position to have
in-house experience with all commonly used wet
granulation methods. Therefore, at the GPS Technology
Centre you can test your material in a fluid bed spray
granulator, top or bottom drive high shear granulator
with fluid bed drying, with all tests being made in
development, pilot scale plant or small scale
production, depending on your needs.
At the GPS Technology Centre we can handle product
volume from 20g to 100kg.
Test and development
GEA Pharma Systems has many years of
experience in adapting a wide range of
technologies and processes into viable solutions for
customers whom are looking to maximise potential
opportunities. An on-going development
programme is constantly examining emerging
technologies and their development within the
global environment. The staff work closely with
GEA Pharma Systems (and other GEA Group
companies) sales divisions, providing an in-depth
understanding of current market demands across
the entire process equipment portfolio.
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The staff of our technology centres consists of
very experienced and dedicated people with a
background in engineering, chemistry and
pharmacy. They will assist customers with all
questions concerning processes in GPS
equipment.
A Partnership in
Pharmaceutical R&D
The Process Development Center (PDC) in
High Shear Granulation
Wommelgem, Belgium plays a major role in the
High Shear Granulation can be single process OR
partnership between the customer and GEA Pharma
with integrated fluid bed dryer.
Systems. This fully equipped laboratory offers the
opportunity to benefit from GPS’s years of
Equipment
Scale
Average
Batch Size
Fluid bed
integration
for drying
UltimaGral™ 75
development /
pilot
20kg
Size 2 fluid bed
UltimaGral™ 300
pilot /
small scale
production
100kg
Size 4/5 fluid bed
PMA™ 65
development /
pilot
20kg
Size 2 fluid bed
PMA™ 300
pilot /
small-scale
production
100kg
Size 4/5 fluid bed
experience in wet granulation, pelletising and drying
processes.
Single Pot Processing
A fixed, through-the-wall installation of an
UltimaPro™ 75 High Shear Processor is at the
disposal of GPS’ customers to test the equipment
with their own products. Also, 2 mobile units, an
UltimaPro™ 10 and 25 High Shear Processors are
available to rent, for customers who prefer to
perform tests in their own facilities. Finally, the PDC
also has one or more MicroGrals™ available for
testing small-scale batches or for rent. This enables
processing batches between 100g and 30kg.
Fluid Bed Processing
Granulation, Drying Pelletizing and Coating.
Equipment
From powder to tablet
The PDC has also played a key role in the
development on the new revolutionary concept for
producing tablets, ConsiGma™. ConsiGma™ is a
concept that integrates different techniques for
producing tablets in a continuous manner, such as
Scale
Batch Size
MP Micro™
development
20-200g
STREA-1™
development
0.2-2kg
MP-1™
development
0.2 -6kg
FlexStream™ size 2
development
1-30kg
pilot
1-30kg
Small-scale production
Small-scale production
30-100kg
30-100kg
MP-2/3
FlexStream™ size 4
MP-4/5
continuous high shear granulation or continuous
blending for direct compression. Our customers can
benefit from their experience with this innovative
system during trials on the ConsiGma™ unit
available at the lab. ConsiGma-1™ is wet granulation
systems for early process development. ConsiGma25™ is a continuous wet granulation line integrated
with a Courtoy Modul™ P for compression. The
ConsiGma™-CDC is a direct compression system,
integrating continuous blending and Courtoy
NICA™ Pelletizing
Though more challenging to produce, pellets offer a
lot of advantages over normal tablets.
Equipment: NICA™ E140 & S450
Extrusion
Typical Production Rate
Minimum Batch Size
E-140
0.5-2.0 kg/min
200g
compression technology.
Spheronizing
Analytical tools
Typical Batch Range
S-450
400g—2.0kg
Next to the process equipment, a wide range of
analytical equipment is available for characteristics
of granulate and tablets. PAT tools can be fitted to
Tablet Compression
all process equipment in the PDC for online
For small-scale tablet production and formulation
monitoring of the critical quality attributes.
development - using such a press for R&D work
means saving a lot of up-scaling and surprises.
Equipment: MODUL™ P: single and bi-layer tableting.
19
Process Analytical Technology
Process Intelligence
Optical methods like UV/Vis-, NIR-, IR- or Raman spectroscopy have
earned their spurs in many areas in chemical, pharmaceutical and food
industry for a long time, mainly in off-line applications. The biggest hurdle
to use these optical methods online is the problem of “window fouling”.
The observation window is covered with material (bulk solids, sticky, pulpy
type products etc.) and needs to be cleaned from time to time.
After assisting multiple tests with various customers and suppliers of
optical measurement techniques in its labs, GEA Pharma Systems has
recognised this and developed the Lighthouse Probe™ in cooperation with
J&M Analytik AG. The combination of GPS’s expertise in containment,
automation and pharmaceutical processing and J&M’s expertise in optics
has resulted in a robust and reliable probe with in-line calibration and
cleaning capabilities.
The Lighthouse Probe™ is the only probe on the market that can clean its
observation window online.
In process
measurement position
Thanks to the big observation area, the probe also analyses a volume closer
to normal sampling volumes than traditional probes. This results in a
much more stable measurement. The Lighthouse Probe™ has been adapted
to suit the extensive rate of machinery GPS can deliver. It has a manual
version to fit a R&D machine; a mechanical window clean system for a
pilot plant system and fully automated version suitable for production or
Clean and
calibrate position
high containment systems.
The strength of the Lighthouse Probe™ is that it is not limited to one
supplier of optical spectroscopy:
• For moisture detection, one of the most seen applications, the probe is
configured with an NDC system resulting in an online LOD apparatus.
Thanks to over 30 years of experience, the NDC algorithm for moisture
detection is very robust and precise. This reduces calibration to adjusting
two parameters instead of model development as us is standard with all
spectroscopic system. The development considerably reduces the
investment, installation and maintenance cost
• GPS recognizes and respects the end user’s choice of spectrometers and
can deliver the probe tuned for various brands now.
• As real process understanding comes from combining different
parameters, we also understand that online models can hardly ever be
made using spectra only. The Lighthouse Probe™ can be delivered and
configured with the necessary software to make this possible.
Please ask our sales force for details.
20
CIP position at
end of process
Contacts
GEA Pharma Systems
Aeromatic-Fielder™ Buck®
Courtoy™
GEA Pharma Systems AG
PO Box 112, Hauptstrasse 145, CH-4416 Bubendorf, Switzerland
Tel. +41 61 936 36 36, Fax: +41 61 936 36 00
E-mail: [email protected]
GEA Process Engineering nv
Bergensesteenweg 186, B-1500, Halle, Belgium
Tel. +32 2 363 8300, Fax +32 2 356 0516
E-mail: [email protected]
Aeromatic-Fielder™
GEA Pharma Systems USA
GEA Process Engineering Ltd.
PO Box 15, Eastleigh, Hampshire SO53 4ZD, United Kingdom
Tel. +44 23 8026 7131, Fax +44 23 8025 3381
E-mail: [email protected]
GEA Process Engineering Inc.
9165 Rumsey Road, Columbia,
Maryland, 21045, USA
Tel. +1 410 997 7010, Fax +1 410 997 5021
E-mail: [email protected]
Buck Systems™
GEA Process Engineering Ltd.
Wharfdale House, 257 Wharfdale Road, Tyseley, Birmingham,
B11 2DP, United Kingdom
Tel: +44 121 765 5800, Fax: +44 121 765 5801
E-mail: [email protected]
Collette™
GEA Process Engineering nv
Keerbaan 70, B-2160, Wommelgem, Belgium
Tel. +32 3 350 1211, Fax +32 3 353 2055
E-mail: [email protected]
GEA Process Engineering China Limited
99 Hexiang Road Minhang District,
Shanghai 201109, P.R.China
Tel +86-21-2408 2288, Fax +86-21-2408 2222
[email protected]
GEA Pharma Systems (India) Private Limited
Block No. 8, Phase B, Village Dumad,
Savli Road, Vadodara - 391740 Gujarat, India
Tel. +91 (0) 265 3074 272, Fax +91 265 3074 255,
E-mail: [email protected]
[email protected]
www.geapharmasystems.com
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Based on a strong commitment to research and development, pharmaceutical
technology centres in Belgium, Denmark, Switzerland, the UK, Singapore, and USA
provide global technical support and know-how to the pharmaceutical industry. These
centres of excellence give customers access to a range of test facilities and expert teams
with technical and process know-how. Our teams work closely with our customers to
optimise processes and evaluate their products, enabling them to achieve their process
and production goals.
Contracting Profitable Experience
A world leader in supplying pharmaceutical equipment, GEA Pharma Systems offers
manufacturers all over the world the opportunity to enter into a profitable
partnership for development and contract. GPS combine advanced in-house
technology with a thorough understanding of the pharmaceutical industry to help
customers maximize their development results.
GEA Pharma Systems
www.gea-ps.com
© GEA Pharma Systems 2012. Specifications subject to change without notice. All trademarks recognized.
All copyrights reserved. Under no circumstances should this document or any part of it be copied without GPS’s written consent.
Central Know-How on a Global Scale