GEA Pharma Systems - Christian Berner AS

www.geapharmasystems.com
Central Know-How on a Global Scale
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
© GEA Pharma Systems 2008 Specifications subject to change without notice All trademarks recognized
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 inhouse technology with a thorough
understanding of the pharmaceutical industry to help customers maximize
their development results.
Aeromatic-Fielder
GEA Pharma Systems AG
PO Box 112, Hauptstrasse 145
CH-4416 Bubendorf, Switzerland
Tel: (CH) +41 61 936 36 36, (UK) +44 23 8026 7131
GEA Pharma Systems
[email protected]
Fluid Bed Processor
Aeromatic-Fielder Technologies
GEA Pharma Systems
GEA Pharma Systems is world leader in providing
advanced processing solutions for solid dosage forms to
the pharmaceutical industry. Based on a dedication to
research and durable quality, GEA Pharma Systems
offers a wide range of solutions, from individual pieces
of equipment to complete integrated plants, by uniting
the state-of-the-art technologies of Aeromatic, Buck,
Collette, Courtoy, Fielder, Lyophil, Nica and Niro.
Product Know-How
Process Expertise
•
For more than forty years, Aeromatic-Fielder 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.
Delivering the Right Solutions
A Partnership in Every Perspective
Every Aeromatic-Fielder plant begins with the
Working with Aeromatic-Fielder means entering a
customer’s desire to create a product that will
solid partnership every step of the way, from process
succeed in the market. In Aeromatic-Fielder, the
testing and design to specification of the software
customer finds a partner who will assist him to meet
controlling your new plant. And our comprehensive
that goal. Our expertise includes technologies for
after sales program ensures that your return on
processing Active Pharmaceutical Ingredients using,
investment is optimised throughout the lifetime
Blending, Granulating, Drying, Pelletizing and
of the plant.
Coating.
Safety and the environment
Plants Customised for Success
For full compliance with national, local and in-house
Every pharmaceutical plant and system from
regulations, Aeromatic-Fielder offers a range of
Aeromatic-Fielder is a unique union of proven
emission control options including solvent recovery
technology and individual solutions. Based on
systems, outlet filters and full containment plants.
standard components, we supply plants for cGMP
Equipment can be supplied to meet explosion-proof
production configured to meet the customer’s
and pressure shock standards as required.
specific requirements.
3
• Drying • Granulating • Pelletizing • Coating
Process
Technologies
•
For maximum process flexibility, Aeromatic-Fielder can
supply a single Fluid Bed unit or Multi-Processor™ system
with interchangeable modules.
Drying
Warm air is blown through a perforated distributor to rapidly and gently
dry materials until the required residual moisture content is reached.
Drying
Moisture evaporated from the product is exhausted with the drying air.
Special features
Selection of air distributors
Short process time
Top Spray Granulator
The top spray granulator agglomerates finer particles into larger, free
flowing granulates in a one-pot process. Ingredients are mixed and preheated by an upward flow of heated air. Granulation occurs by spraying
liquid into the fluidized powder. The granules are subsequently dried with
heated air. The top spray granulator can also be used for top spray coating,
layering from liquids, and instantizing.
Top Spray
Granulator
Special features
One pot process
Selection of air distributors
Spray Dryer Granulator
The spray dryer granulator transforms suspensions or solutions into dry,
free-flowing, dustless granules. A suspension or solution of the substance
to be dried is sprayed onto warm air, simultaneously drying and
agglomerating the product. Batch or continuous discharge is available – in
the continuous mode, the product is discharged at a controlled rate to
maintain an optimum bed height
Spray
Dryer
Special features
Compact unit
Easy scale-up
Batch or continuous discharge
4
Granulator
Built-in Versatility
Precision-Granulator™
A rotating high velocity air stream is established in the central
agglomeration tube. Particles are picked up at the base of the tube
Precision
and accelerated by the air stream. The particles come into contact
Granulator
with liquid droplets produced from the spray nozzle at the base of
the tube \ the relative velocity of air, liquid droplets and particles
are high so wetting is efficient and drying begins almost
immediately. Most of the feed material is in the outer “holding
area”, where the gas velocity is very low. Attrition is greatly
reduced. The gas humidity is also low in the holding area so the
material is dry not sticky. Individual particles may make repeated
cycles (typically from 10 to 1,000) through the tube, allowing very
large agglomerates to be built up.
Precision-Coater™
Used for smaller particles, such as powders, granules, seeds, crystals,
pellets, and small tablets. The product is coated and partially dried by
Precision
Coater
being blown upward through a central column with atomized liquid
and drying air. The material falls into the outer part of the container
where heated air completes the drying process. On reaching the air
distributor at the base of the module, the product flows again into
the central column for further coating. This process continues until
the specified degree of coating is obtained.
Special features
High spray rates for short processes
Highly controlled product movement
Minimal agglomeration or granulation
5
Batch Fluid
Technology
•
Using proven standard components, Aeromatic-Fielder can supply
both simplicity and flexibility in plant design. User-selected process
modules, filters, control systems and air preparation units combine
in a system to meet process requirements exactly. This modular
approach ensures that qualification and validation procedures are
kept to a minimum.
Through-the-wall installation
By positioning the support column at the back of the
fluid bed, a through-the-wall installation is achieved
which ensures that all the auxiliary equipment is
housed outside the process room. This greatly
simplifies compliance with GMP guidelines.
Solvent emission control
External
bag fitter
Normally used in
conjunction with
the particle
retainer to
collect dust from
the fluid bed in
coating
applications.
A range of open- and closed-cycle systems for
removing or recovering organic solvents is available.
Options include condensation, adsorption, thermal
oxidation and wet scrubbing.
Spraying systems
Nozzles, pumps and liquid preparation units are
supplied according to process needs.
Product discharge
For automatic product discharge, pneumatic
conveying or gravity-based systems are available for
Open Cycle
Design
use with the Non-Sifting Gill Plate™ air distributor
technology.
Inlet air preparation unit
Inlet air is treated using a series of filters and
conditioning units according to the sensitivity of the
process and the ambient climatic conditions. Options
range from the basic minimum, consisting of a prefilter, heater and final filter, to full air-conditioning to
provide consistent processing conditions all year
round. Condensers are used for dehumidifying in
most applications, but for hygroscopic or
effervescent products which require a very low dew
point, additional adsorption devices can be installed.
Humidification is achieved by an injection of steam.
6
Quick
closing valve
HEPA filter
Optimized Designs
Process filters
In granulation, drying, and most pelletizing
applications, a process filter is used to trap
mall particles, which are returned to the bed
Quick closing
valve
when the filter is cleaned. In coating
Silencer
applications, fine particles usually need to be
removed. Fluid beds that are used for more
than one type of process can be supplied
Police filters
Suction fan
1
with interchangeable process filters.
1 Single shaker bag filter
A simple, basic filter with a single bag,
which is cleaned by shaking. Fluidization
stops during filter cleaning.
2 Multi shaker bag filter
2
This filter is divided into two or more
sections, with a separate filter bag in each
Pre-filter
one. Bags are cleaned individually by
shaking the filter, while fluidization
continues in the other sections, for faster
and more efficient production.
Pre-heater
3 Blow-back filter
There are multiple filter bag sections in this
3
design. Cleaning takes place one bag at a
Humidifier
time, so that a large proportion of the filter
is always available for continuous
fluidization.
4 Cartridge filter
Stainless steel filter cartridges are cleaned
one at a time, so that a large proportion of
Filter
Heater (face
and by-pass)
Cooler/
condenser
the filter is always available for continuous
4
fluidization. Unlike bag filters, this system
can be cleaned-in-place.
5 Particle retainer
Used for coating applications, this design
retains the coarser particles and returns
them to the process, removing the dust to an
external filter unit.
5
7
Your Process
•
Understanding
& Controlling
For optimum compatibility with existing plant control strategies,
fluid bed systems are available with a choice of manual or FDA
compliant automated controls. Programmable logic controller
(PLC) and PC-based options offer a wide range of recipe handling,
data acquisition and network communication functions.
SynTQ PAT data analysis and
modelling platform
Materials
information
Multivariate
analysis
PAT data
Process
engineering
models
Process
optimisation
Controls
The PLC front panel key-pad and built-in monitor
are used for recipe programming and real-time
process MIMIC display.
For optimum compatibility with existing plant
control strategies, fluid bed systems are available
with a choice of manual or FDA compliant
automated controls. Programmable logic controller
(PLC) and PC-based options offer a wide range of
Drying curve monitored by
NDC Pharmaveiw NIR
moisture measurement system
recipe handling, data acquisition and network
communication functions.
Monitoring of coat growth
using Zeiss Corona NIR
8
Monitoring coating conditions
GPS real time process humidity model
(RTPD) (above) to navigate the pychometric
chart (below
In processs measurement position
Clean and calibrate position
GEA Pharma Systems integrate process
engineering and PAT to provide Process
Intelligence
The FDA’s PAT (process analytical technologies)
initiative has enabled GPS Pharma Systems to
combine its equipment design skills and process
engineering know–how in order to integrate online
(PAT) analysers into its process systems in a way
which can provide real insight into the operation of
the process and help customers achieve key product
quality target .
The goal of the PAT initiative is to ensure that
pharmaceutical products are manufactured using
processes which are understood and monitored so
that the key quality characteristics of the products
can be actively controlled.
Combining process monitoring using online
analysers, together with solid process engineering
principles and advanced process modelling
techniques will enable processes to be actively
controlled in order to compensate for minor input
variations (eg. raw materials) so that the
specifications for the final product will be closer to
the ideal target.
Using process models to identify the process
conditions that highlite products which perform
best in subsequent processes will enable the whole
production process to be targeted towards the
performance of the final dose rather than just
optimising each unit operation individually. GPS
Pharma Systems wide scope gives it a unique
perspective on the complete process.
CIP position at end of process
Lighthouse Probe™
Technology
GEA Pharma Systems (GPS) has joined
forces with J&M GmbH to create a
compact and cleanable in-process optical
probe for use in powder processing
equipment.
The result is the novel Lighthouse Probe™, which
can be used with a range of spectroscopic
techniques, including NIR and UV/vis, to overcome
the traditional problem of product sticking to
observation windows.
The probe is compact and easy to install and makes
it possible to take a reliable in process measurement
of quality critical product characteristics including:
• Material and active content identification
• Active content uniformity during high shear
blending operations
• Moisture content and end-point during
drying processes
• Coat growth during coating processes
Optical methods such as UV/Vis or NIR
spectroscopy can be very powerful tools for
analysing a range of product characteristics, but in
processes involving wet and sticky powders it is
necessary to ensure that the system has a clear view
of the product. Conventional windows used in
process equipment such as fluid bed systems or high
shear granulators, have always suffered from the
risk of window fouling. The new GPS & J&M
Lighthouse Probe™ has overcome this problem.
9
Sizes &
Capacities
Meeting Every
Requirement •
Standard modules configured into tailor-made plants.
The philosophy behind the design is that a combination of
standardised modules are built together in order to meet the
requirement for a specific duty. Therefore, dryers of equal capacity
may be completely different with respect to design, configuration
and physical size.
To meet the high requirements of the pharmaceutical industry,
Aeromatic-Fielder has a series of fluid bed systems suitable for
formulation, process development, production of clinical material
through to full-scale production.
Production capacities
150
300
400
400
600
800
1200
1800
2400
3000
(Size 3)
(Size 4)
(Size 5)
(Size 5) K3
(Size 6)
(Size 6) K3
(Size 7)
(Size 8)
(Size 9)
(Size 10)
30 to 100 L
60 to 200 L
90 to 300 L
90 to 400 L
120 to 400 L
120 to 600 L
240 to 800 L
360 to 1200 L
480 to 1600 L
600 to 2000 L
15 to 50 kg
30 to 100 kg
45 to 150 kg
60 to 200 kg
60 to 200 kg
90 to 300 kg
120 to 400 kg
180 to 600 kg
240 - 800 kgs
320 to 1200 kg
125 L
225 L
355 L
450 L
600 L
650 L
900 L
1350 L
1800 L
2250 L
Typical working
capacity
Typical batch
capacity
(average product density 0.5kg/l)
Maximum
working volume
Values are process and product specific and may vary from those shown above.
10
Integration
Optimum
Process Efficiency
•
Current Good Manufacturing Practices increasingly require that
product is fully contained during processing to protect operators
and environment. Integrated process systems not only offer
containment but improved productivity through automation,
increased yield and efficient cleaning procedures.
System integration
GEA Pharma Systems specialises in the design and
manufacture of fluid bed and high-shear granulation
technology and is uniquely qualified to provide
state-of-the-art integrated high shear mixergranulator and fluid bed drying technology. Drawing
on its world-class expertise, GPS Pharma Systems
offers fully integrated turnkey installations. The
service includes: design, installation assistance,
commissioning, process validation, as well as
training, and technical support. Installation,
operation qualification and documentation are
carried out according to FDA/GAMP guidelines.
Integration by design
Aeromatic-Fielder’s entire range of process
equipment is designed with system integration in
mind. A modular approach allows customers to
select standard process modules to suit project
needs. Fluid bed dryers and coaters can be combined
with top-drive and bottom-drive high shear mixergranulators, wet and dry milling facilities, product
handling systems, binder and coating preparation
units, filtration units, all designed for fully
integrated systems. Safety, containment, product
flow and building requirements are in-built for full
integration for optimum process efficiency
11
Design
Cleanability &
Maintenance •
Process optimisation depends on efficient, effective
cleaning. Automation of the cleaning process ensures
repeatability, allows validation and minimises down-time.
In recognition of the fundamental role played in today’s
advanced powder processing industry by automated cleanin-place procedures Aeromatic-Fielder has developed a
unique approach to CIP.
WIP and CIP
All process plant can be supplied with a basic
wash-
in-place (WIP) system or with fully automated
cleaning-in-place system. CIP options for the fluid bed
processor include process filters that do not have to be
removed for cleaning.
CIP Kitchen
12
Safety &
the environment
•
Continuous
Improvement
For full compliance with national, local and in-house regulations,
GPS Pharma Systems offers a range of emission control options
including solvent recovery systems, outlet filters and full
containment plants. Equipment can be supplied to meet
explosion-proof and pressure shock standards as required.
Improved safety for integrated granulation
the VDI standard - or where the configuration of the
and drying suites
interconnecting duct is outside the safe design
Extensive safety testing confirms pressure
parameters, then either the granulator must be
enhancement effects and identifies safe design
designed to a higher pressure shock resistance or a
limits for integrated systems GPS Pharma Systems
hygienic fast acting valve, or some other form of
in conjunction with the FSA, the safety specialist
protection, is essential. The test program showed
centre in Germany, have carried out an extensive test
that the pressure enhancement effects are caused by
programme involving over 100 test explosions. This
the difference in the propagation speed between the
research has shown conclusively that should an
pressure wave and the flame front. The worst cases
explosion occur during the transfer operation in an
are when the pressure in the granulator is able to
integrated system where a granulator is connected
rise significantly before the flame can reach it and
directly to a fluid bed dryer without an explosion
ignite the pre-compressed material. For the range of
isolation valve, the secondary explosion pressures in
transfer duct configurations to be used with the 16-
the granulator can be significantly higher than in
bar granulator design, the presence of bends and
the fluid bed. These tests have enabled GPS Pharma
obstructions such as mills was not seen to affect the
Systems to gain full EC type approval for a range of
increase in pressure.
pressure shock resistant integrated systems and 16-
For plant processing powders, or mixtures that are
bar pressure shock resistant high shear granulators.
not flammable at the time of transfer between the
granulator and the fluid bed, then the risk of
Safety when using organic solvents
explosion is eliminated and hence a wider range of
The tests were carried out with hybrid mixtures that
transfer duct designs can be used safely. This
behave in the same way as pharmaceutical products
extensive research program has significantly
containing organic solvents and showed that the final
advanced the state of the art in safety technology for
explosion pressure in the granulator is dependent on
pharmaceutical plants and confirms GPS Pharma
the volumes of the two vessels and that the length
Systems’ commitment to introducing new products
and diameter of the interconnecting duct is critical in
which are based on sound research and development
ensuring that the pressure remains within safe limits.
using solid process know how and understanding.
The tests showed that where the fluid bed is designed
in accordance with VDI 2263 part 5 (i.e.: for a 10-bar
explosion pressure, which the standard considers to
be adequate for all pharmaceutical powders and
organic solvent combinations), then the granulator
must be able to withstand an over pressure of at least
16 bar to provide a range of transfer duct
configurations which are both practical and safe.
Where the fluid bed is required to handle materials
with explosion pressures greater than 10 bar (e.g.:
metal powders) - and hence is designed outside of
10 bar PSR
design (no
relief duct
neccessary)
Explosion
suppression
system (no relief
duct neccessary)
2 bar PSR
design with
explosion
relief duct
13
The Complete
Partnership •
Working with you…
Entering a partnership with Aeromatic-Fielder means entering a partnership that does
not end until you are completely satisfied. From the moment you have specified your
user requirements and until the plant has been put into service and has been
qualified, our trained staff stays with you at every step of the process, working in
close co-operation with your own staff creating the components and systems that will
result in a finished plant.
Client Verification
Customer
responsibilty
User Requirements
Process Qualification
Functional Specification
Aeromatic-Fielder /
Client Verification
Operational Qualification
Joint tasks
Software
design
Aeromatic-Fielder
responsibilty
Hardware
design
Mechanical
design
Installation Qualification
Mechanical equipment build
FAT testing
Hardware manufacturing
Integrated testing
Software Configuration
Bench testing
…Every Step of the Way
Based on years of experience, equipment qualification will be carried out according to
an agreed plan using documents prepared by Aeromatic-Fielder.
Our engineers will contribute to a successful qualification of the equipment in close
co-operation with your validation staff.
14
Service
for Life
•
Project Management
The expertise of the Aeromatic-Fielder engineering
team is available to help customers find the
optimum solution for their individual processing
needs. The company assists with single phases of a
project, or takes full responsibility for design and
installation of a complete turnkey plant.
Training
Operators of Aeromatic-Fielder equipment can
undergo training to help them maximise efficiency,
either at the time of installation or periodically as
required.
After Sales
Regular maintenance is essential to ensure
equipment operates to maximum efficiency. Fully
trained engineers can carry out on-site servicing and
calibration of equipment, either as part of a planned
maintenance programme or in response to customer
need. Replacement parts can be supplied from stock
or manufactured to order.
To avoid the expense of equipment replacement
Aeromatic-Fielder can upgrade existing systems and
plant to meet different operational parameters, to
comply with changing regulations, or to modify for
use at another location.
15