Download - Fluid Bed Processor
-
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
Delivering the Right Solutions
Every Aeromatic-Fielder plant begins with the
customers desire to create a product that will
succeed in the market. In Aeromatic-Fielder, the
customer finds a partner who will assist him to meet
that goal. Our expertise includes technologies for
processing Active Pharmaceutical Ingredients using,
Blending, Granulating, Drying, Pelletizing and
Coating.
Plants Customised for Success
Every pharmaceutical plant and system from
Aeromatic-Fielder is a unique union of proven
technology and individual solutions. Based on
standard components, we supply plants for cGMP
production configured to meet the customers
specific requirements.
For more than forty years, Aeromatic-Fielder has supplied advancedsolids processing plants for blending, granulating, drying, pelletizingand coating to the pharmaceutical industry. This includes smallcapacity systems designed for R & D as well as industrial size plantsfor batch production of pharmaceutical compounds under cGMPconditions.
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.
A Partnership in Every Perspective
Working with Aeromatic-Fielder means entering a
solid partnership every step of the way, from process
testing and design to specification of the software
controlling your new plant. And our comprehensive
after sales program ensures that your return on
investment is optimised throughout the lifetime
of the plant.
Safety and the environment
For full compliance with national, local and in-house
regulations, Aeromatic-Fielder 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.
Process Expertise
3
-
4 Drying Granulating Pelletizing Coating
ProcessTechnologies
Drying
Warm air is blown through a perforated distributor to rapidly and gently
dry materials until the required residual moisture content is reached.
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 pre-
heated 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.
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
Special features
Compact unit
Easy scale-up
Batch or continuous discharge
For maximum process flexibility, Aeromatic-Fielder cansupply a single Fluid Bed unit or Multi-Processor systemwith interchangeable modules.
Drying
Top Spray
Granulator
Spray
Dryer
Granulator
-
Built-in Versatility
5
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
and accelerated by the air stream. The particles come into contact
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
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
Precision
Granulator
Precision
Coater
-
Batch FluidTechnology
6
Externalbag fitterNormally used inconjunction withthe particleretainer tocollect dust fromthe fluid bed incoatingapplications.
Quickclosing valve
HEPA filter
Open CycleDesign
Using proven standard components, Aeromatic-Fielder can supplyboth simplicity and flexibility in plant design. User-selected processmodules, filters, control systems and air preparation units combinein a system to meet process requirements exactly. This modularapproach ensures that qualification and validation procedures arekept 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
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
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 pre-
filter, 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.
-
Optimized Designs
7
Process filters
In granulation, drying, and most pelletizing
applications, a process filter is used to trap
mall particles, which are returned to the bed
when the filter is cleaned. In coating
applications, fine particles usually need to be
removed. Fluid beds that are used for more
than one type of process can be supplied
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
This filter is divided into two or more
sections, with a separate filter bag in each
one. Bags are cleaned individually by
shaking the filter, while fluidization
continues in the other sections, for faster
and more efficient production.
3 Blow-back filter
There are multiple filter bag sections in this
design. Cleaning takes place one bag at a
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
the filter is always available for continuous
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.
Filter Heater (faceand by-pass)
Cooler/condenser
Humidifier
Pre-heater
Pre-filter
Suction fanPolice filters
Silencer
Quick closingvalve
1
2
3
4
5
-
Your Process
Understanding& Controlling
8
For optimum compatibility with existing plant control strategies,fluid bed systems are available with a choice of manual or FDAcompliant automated controls. Programmable logic controller(PLC) and PC-based options offer a wide range of recipe handling,data acquisition and network communication functions.
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
recipe handling, data acquisition and network
communication functions.
SynTQ PAT data analysis andmodelling platform
Process engineeringmodels
Multivariateanalysis
Materialsinformation
PAT data
Process optimisation
Drying curve monitored byNDC Pharmaveiw NIR
moisture measurement system
Monitoring coating conditionsGPS real time process humidity model
(RTPD) (above) to navigate the pychometricchart (below
Monitoring of coat growthusing Zeiss Corona NIR
-
9GEA Pharma Systems integrate processengineering and PAT to provide ProcessIntelligence
The FDAs PAT (process analytical technologies)
initiative has enabled GPS Pharma Systems to
combine its equipment design skills and process
engineering knowhow 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.
Lighthouse ProbeTechnology
GEA Pharma Systems (GPS) has joinedforces with J&M GmbH to create acompact and cleanable in-process opticalprobe for use in powder processingequipment.
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
In processs measurement position Clean and calibrate position CIP position at end of process
-
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)
Typical working
capacity 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
Typical batch
capacity
(average product density 0.5kg/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
Maximum
working volume 125 L 225 L 355 L 450 L 600 L 650 L 900 L 1350 L 1800 L 2250 L
Values are process and product specific and may vary from those shown above.
Sizes &Capacities
Meeting EveryRequirement
10
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.
-
Integration
11
OptimumProcess Efficiency
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 mixer-
granulator 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-Fielders 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 mixer-
granulators, 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
Current Good Manufacturing Practices increasingly require thatproduct is fully contained during processing to protect operatorsand environment. Integrated process systems not only offercontainment but improved productivity through automation,increased yield and efficient cleaning procedures.
-
Design
Cleanability &Maintenance
12
Process optimisation depends on efficient, effectivecleaning. Automation of the cleaning process ensuresrepeatability, allows validation and minimises down-time.In recognition of the fundamental role played in todaysadvanced powder processing industry by automated clean-in-place procedures Aeromatic-Fielder has developed aunique 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
-
ContinuousImprovement
13
Safety &the environment
Improved safety for integrated granulation
and drying suites
Extensive safety testing confirms pressure
enhancement effects and identifies safe design
limits for integrated systems GPS Pharma Systems
in conjunction with the FSA, the safety specialist
centre in Germany, have carried out an extensive test
programme involving over 100 test explosions. This
research has shown conclusively that should an
explosion occur during the transfer operation in an
integrated system where a granulator is connected
directly to a fluid bed dryer without an explosion
isolation valve, the secondary explosion pressures in
the granulator can be significantly higher than in
the fluid bed. These tests have enabled GPS Pharma
Systems to gain full EC type approval for a range of
pressure shock resistant integrated systems and 16-
bar pressure shock resistant high shear granulators.
Safety when using organic solvents
The tests were carried out with hybrid mixtures that
behave in the same way as pharmaceutical products
containing organic solvents and showed that the final
explosion pressure in the granulator is dependent on
the volumes of the two vessels and that the length
and diameter of the interconnecting duct is critical in
ensuring that the pressure remains within safe limits.
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
the VDI standard - or where the configuration of the
interconnecting duct is outside the safe design
parameters, then either the granulator must be
designed to a higher pressure shock resistance or a
hygienic fast acting valve, or some other form of
protection, is essential. The test program showed
that the pressure enhancement effects are caused by
the difference in the propagation speed between the
pressure wave and the flame front. The worst cases
are when the pressure in the granulator is able to
rise significantly before the flame can reach it and
ignite the pre-compressed material. For the range of
transfer duct configurations to be used with the 16-
bar granulator design, the presence of bends and
obstructions such as mills was not seen to affect the
increase in pressure.
For plant processing powders, or mixtures that are
not flammable at the time of transfer between the
granulator and the fluid bed, then the risk of
explosion is eliminated and hence a wider range of
transfer duct designs can be used safely. This
extensive research program has significantly
advanced the state of the art in safety technology for
pharmaceutical plants and confirms GPS Pharma
Systems commitment to introducing new products
which are based on sound research and development
using solid process know how and understanding.
For full compliance with national, local and in-house regulations,GPS Pharma Systems offers a range of emission control optionsincluding solvent recovery systems, outlet filters and fullcontainment plants. Equipment can be supplied to meetexplosion-proof and pressure shock standards as required.
10 bar PSRdesign (norelief ductneccessary)
Explosionsuppression
system (no reliefduct neccessary)
2 bar PSRdesign withexplosionrelief duct
-
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.
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.
The CompletePartnership
14
Client Verification
Aeromatic-Fielder /
Client Verification
User Requirements
Functional Specification
Softwaredesign
Hardwaredesign
Mechanicaldesign
Process Qualification
Operational Qualification
Installation Qualification
FAT testing
Integrated testing
Bench testing
Mechanical equipment build
Hardware manufacturing
Software Configuration
Customerresponsibilty
Aeromatic-Fielderresponsibilty
Joint tasks
-
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.
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.
15
Servicefor Life
-
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
them to achieve their process and production goals.
Contracting Protable Experience
A world leader in supplying
pharmaceutical equipment, GEA Pharma
Systems oers manufacturers all over
the world the opportunity to enter into a
protable 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
PharmaSystem
s20
08Sp
ecicatio
nssubjecttoch
ange
with
outn
oticeAlltrad
emarks
reco
gnized
GEA Process Engineering Inc. 9165 Rumsey Road Columbia, MD 21045Tel: 410-997-8700 Fax: 410-997-5021 Email: [email protected]: www.niroinc.com