Process Engineering

Division

Fluid Bed
Technology
by Aeromatic-Fielder
 For more than thirty 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.

Product Know-How

Process Expertise
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.

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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.
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.

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.

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Process Technologies
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
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Built-in versatility
For maximum process flexibility,
Aeromatic-Fielder can supply a
single Fluid Bed unit or Multi-
Processor system with
interchangeable modules.
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

Drying
Granulating
Pelletizing
Coating
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
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 Batch Fluid Technology Quick closing
Optimized designs valve

Using proven standard

components, Aeromatic-Fielder
can supply both simplicity and External bag filter
flexibility in plant design. Normally used in
conjunction with the
User-selected process modules,
particle retainer to
filters, control systems and air collect dust from the
fluid bed in coating
preparation units combine in a
applications.
system to meet process
requirements exactly.
This modular approach ensures
that qualification and validation Two-way quick
closing valve
procedures are kept to
a minimum.

Open Cycle
Design

Quick HEPA filter Filter

closing valve

Through-the-wall installation Solvent emission control Product discharge

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.
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.
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

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 Process filters
In granulation, drying, and most
pelletizing applications, a process filter
is used to trap small particles, which are
returned to the bed when the filter is
Silencer cleaned. In coating applications, fine
Police filters particles usually need to be removed.
Suction fan Fluid beds that are used for more than
1
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

Pre-filter
This filter is divided into two or more 2
sections, with a separate filter bag in
each one. Bags are cleaned individually
Pre-heater
by shaking the filter, while fluidization
continues in the other sections, for faster
and more efficient production.

Humidifier
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 3
of the filter is always available for

Heater (face Cooler/ continuous fluidization.

and by-pass) condenser

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.
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
4
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.

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 Understanding and controlling

Your Process
SynTQ PAT data analysis and
modelling platform

Materials Multivariate
information 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
Drying curve monitored by Monitoring coating conditions using
PC-based options offer a wide range of
NDC Pharmaview NIR NPS real time process humidity model
recipe handling, data acquisition and moisture measurement system (RTPD) (above) to navigate the
network communication functions. psychrometric chart (below)

Monitoring of coat growth

using Zeiss Corona NIR

Aeromatic-Fielder Process Engineering + Online Analysis + Process Modelling = Process understanding

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Niro Pharma Systems integrate
process engineering and PAT to
provide Process Intelligence
The FDAs PAT (process analytical
technologies) initiative has enabled
Niro 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 Lighthouse Probe Technology The result is the novel Lighthouse
Niro Pharma Systems (NPS) has Probe, which can be used with a
provide real insight into the operation
joined forces with J&M GmbH to range of spectroscopic techniques,
of the process and help customers
create a compact and cleanable in- including NIR and UV/vis, to overcome
achieve key product quality target .
process optical probe for use in the traditional problem of product
powder processing equipment. sticking to observation windows.
The goal of the PAT initiative is to
ensure that pharmaceutical products are
The probe is compact and easy to install
manufactured using processes which
and makes it possible to take a reliable
are understood and monitored so that
in process measurement of quality
the key quality characteristics of the
critical product characteristics
products can be actively controlled.
including:

Combining process monitoring using

Material and active content
online analysers, together with solid
identification
process engineering principles and
In process measurement position Active content uniformity during
advanced process modelling techniques
high shear blending operations
will enable processes to be actively
Moisture content and end-point
controlled in order to compensate for
during drying processes
minor input variations (eg. raw materials)
Coat growth during coating processes
so that the specifications for the final
product will be closer to the ideal target.
Optical methods such as UV/Vis or
NIR spectroscopy can be very powerful
Using process models to identify the
tools for analysing a range of product
process conditions that highlite
characteristics, but in processes involving
products which perform best in Clean and calibrate position
wet and sticky powders it is necessary to
subsequent processes will enable the
ensure that the system has a clear view
whole production process to be targeted
of the product. Conventional windows
towards the performance of the final
used in process equipment such as fluid
dose rather than just optimising each
bed systems or high shear granulators,
unit operation individually. Niro
have always suffered from the risk of
Pharma Systems wide scope gives it a
window fouling. The new NPS & J&M
unique perspective on the complete
Lighthouse Probe has overcome
process.
this problem.
CIP position at end of process

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 Meeting Every Requirement

Sizes & capacities

Standard modules configured The philosophy behind the design is
into tailor-made plants 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)
Typical working
capacity 30 to 100 L 60 to 200 L 90 to 300 L 120 to 400 L 120 to 400 L 180 to 600 L 240 to 800 L 360 to 1200 L 480 to 1600 L 720 to 2400 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 90 to 800 kg 360 to 1200 kg

Maximum
working volume 125 L 225 L 355 L 450 L 600 L 650 L 900 L 1350 L 650 L 900 L

Values are process and product specific and may vary from those shown above.

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 Integration
for 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
Niro 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, Niro 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.

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 Design for

Cleanability
& Maintenance
Process optimisation depends on WIP and CIP
efficient, effective cleaning. All process plant can be supplied with a
Automation of the cleaning basic wash-in-place (WIP) system or
process ensures repeatability, with fully automated cleaning-in-place
allows validation and minimises system. CIP options for the fluid bed
down-time. In recognition of the processor include process filters that do
fundamental role played in not have to be removed for cleaning.
todays advanced powder
processing industry by automated
clean-in-place procedures
Aeromatic-Fielder has developed
a unique approach to CIP. CIP Kitchen

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Continuous improvement for
Safety
Safety and the environment
For full compliance with national, local
and in-house regulations, Niro 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 and drying suites
Extensive safety testing confirms pressure
enhancement effects and identifies safe
design limits for integrated systems Niro
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 Niro 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 For plant processing powders, or
and diameter of the interconnecting mixtures that are not flammable at the
duct is critical in ensuring that the time of transfer between the granulator
pressure remains within safe limits. and the fluid bed, then the risk of
explosion is eliminated and hence a
The tests showed that where the fluid wider range of transfer duct designs can
bed is designed in accordance with VDI be used safely. This extensive research
2263 part 5 (i.e.: for a 10-bar explosion program has significantly advanced the
pressure, which the standard considers state of the art in safety technology for
to be adequate for all pharmaceutical pharmaceutical plants and confirms
powders and organic solvent Niro Pharma Systems commitment to
combinations), then the granulator must introducing new products which are
be able to withstand an over pressure of based on sound research and
at least 16 bar to provide a range of development using solid process know
transfer duct configurations which are how and understanding.
both practical and safe.
Where the fluid bed is required to handle
materials with explosion pressures
10 bar PSR
greater than 10 bar (e.g.: metal powders) -
design (no relief
and hence is designed outside of the VDI duct necessary).
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 Explosion
suppression
showed that the pressure enhancement
system (no relief
effects are caused by the difference in the duct necessary).
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 2 bar PSR design
be used with the 16-bar granulator with explosion
relief duct.
design, the presence of bends and
obstructions such as mills was not seen to
affect the increase in pressure.
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 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
The Complete process, working in close co-operation
with your own staff creating the

Partnership components and systems that will result

in a finished plant.

Customer
responsibilty Client Verification
User Requirements Process Qualification

Joint tasks Aeromatic-Fielder /

Functional Specification Operational Qualification
Client Verification

Software Hardware Mechanical

design design design Installation Qualification

Aeromatic-Fielder
responsibilty Mechanical equipment build FAT testing

Hardware manufacturing Integrated testing

Software Configuration Bench testing

Every Step of the Way

Based on years of experience, equipment Our engineers will contribute to a
qualification will be carried out according successful qualification of the
to an agreed plan using documents equipment in close co-operation with
prepared by Aeromatic-Fielder. your validation staff.

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 Service
for Life

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.

Training
Operators of Aeromatic-Fielder
equipment can undergo training to help
them maximise efficiency, either at the
time of installation or periodically as
required.

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.

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 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
Profitable Experience
A world leader in supplying pharmaceutical
equipment, Niro Pharma Systems offers
manufacturers all over the world the
opportunity to enter into a profitable partnership for
development and contract. NPS combine advanced in-
house technology with a thorough understanding of the
pharmaceutical industry to help customers maximize
their development results.
Aeromatic-Fielder
Process Engineering
Division
A company of GEA Group
Niro 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, Niro 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,
All trademarks recognized
Collette, Courtoy, Fielder, Lyophil, Nica and Niro.
Niro Pharma Systems 2006 Specifications subject to change without notice
Sales enquiries:
Aeromatic-Fielder AG
PO Box 112 Hauptstrasse 145
CH-4416 Bubendorf Switzerland
Tel: +41 61 936 36 36 Fax: +41 61 936 36 00
E-mail: aeromatic-fielderCH@niropharma.com
Aeromatic-Fielder
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: aeromatic-fielderGB@niropharma.com
For North America Contact:
NPS-Aeromatic-FBT-GB
Niro Pharma Systems
9165 Rumsey Road
Columbia Maryland 21045, USA
Tel: +1 410 997 7010 Fax: +1 410 997 5021
E-mail: info@niroinc.com
W W W . N I R O P H A R M A . C O M