Pharmaceutical Biotechnology 9997 8203 030

Pharmaceutical Biotechnology
Downstream Processing with Centrifuges and Package Units

from GEA Westfalia Separator
Separation. Solution. Success.
Mechanical Separation / GEA Westfalia Separator
Quality in its Purest Form

GEA Westfalia Separator downstream processing technology
Aseptic process management, optimum cleaning
production processes and products. A critical
capability,
closed
reliable
factor underlying the success of the company in
compliance
with
product
GMP
handling,
gentle
pharmaceutical biotechnology is its ability to
product treatment, ecient recovery of active
requirements,
swiftly translate new developments into marketable
ingredients and reliable scale-up the require-
processes
ments of pharmaceutical biotechnology are high.
the complex requirements of biotechnological
With separators designed specically for this
processes. The basis for this is decades of experience
sector, GEA Westfalia Separator stands for reliable
in the construction and production of separators
compliance with these requirements.
for the pharmaceutical industry, picking up on
and
systems
which
fully
meet
new research ndings and the implementation of

GEA Westfalia Separator built the rst centrifuge in
the latest design and production processes. Using
Oelde, Westphalia in 1893. Since then, the company
this
has been instrumental in the advancement of
developed numerous innovative improvements to
mechanical separation technology. Today, it is a key
separating processes and brought them to market
technology in the recovery of active pharmaceutical
world-wide by applying rst-class engineering.
ingredients with substantial potential for optimising
2
GEA Westfalia Separator
approach,
GEA
Westfalia
Separator
has
Efcient, reliable and economical

GEA Westfalia Separator supports new developments
in the branch from the outset through continuous
cooperation with universities, research institutes
and industry. In this way, a rapid and individual
response to current customer needs is assured at all
times. With stand-alone machines or package units
which guarantee a high yield of valuable substances
and which operate trouble-free, eciently, reliably
and economically throughout a long service life.
Convince yourself!
3
Enzymes
Process acceleration with biocatalysts
Enzymes are complex organic protein compounds
Production of extracellular enzymes
located in every living cell, where they are produced.
Separators and decanters from GEA Westfalia
They accelerate organic processes such as the
Separator are predestined for the optimum treatment
breakdown of starch, protein, fat or sugar as
of washing powder enzymes. Carefully purified and
catalysts, i.e. without being expended themselves.
sterilised air is injected into a fermenter equipped
These valuable proteins are known to industry
with an agitator. The air bubbles are distributed
as esteemed helpers. The separators and
in the nutrient solution, which is composed of
decanters from GEA Westfalia Separator ensure
carbohydrates, protein, growth agents and nutrients.
that the intracellular and extracellular enzymes are
This is sterilised, heated to an optimum temperature
separated undamaged and in high concentrations.
and then inoculated with the purified culture of a

nonpathogenic microorganism. The microorganisms
Production of intracellular enzymes
nourish themselves by converting the substances
Glucose isomerase is an example of an enzyme which
and simultaneously produce the enzymes. These
converts glucose into fructose and is highly
are then excreted to the fermentation broth. After
significant in the starch industry. The enzyme is
fermentation, the microorganisms are separated by
produced and remains in the cells of the employed
adding a flocculent and centrifuging with separators
micro-organisms. To process it, the liquid phase of the
and decanters. Succeeding stages of washing and
fermentation broth is separated by centrifuging after
polishing with centrifuges further increase the yield
fermentation. The concentrated microorganisms are
and the purity of the enzymes.
treated further after centrifuging. The cell walls are

broken down. Depending on the consistency of the
suspension, it is diluted before the cell fragments are
separated by continuously operating separators.
4
Intracellular enzymes
Extracellular enzymes
5
Starter Cultures
On everyones lips
Starter cultures are literally on everyones lips. The
packaged under oxygen exclusion and stored at low
helpful microorganisms are employed in the most
temperatures. This retains their activity for months
diverse fields of the food industry and also as a
before they are processed, e. g. as live cultures in
probiotic dietary supplement. Examples are the
probiotic yoghurts.
dairy, meat and bakery industries, in the production

of fermented vegetables, in the production of
wine and beer and in the fodder industry. Starter
cultures are cultivated from undefined, empirically
produced species to attain a predictable and
reproducible quality and quantity of the product.
Cultivation, processing, harvesting

The production of starter cultures can be divided into
two sections. After cultivation in fermenters, the
bacteria must be processed and separated from the
fermentation solution. This consists of the nurtured
lactobacilli and the remainder of the nutrient solution
including the produced lactic acid. Firstly, the
micro-organisms are separated and concentrated
from the liquid phase. Nozzle and self-cleaning disc
separators in steam-sterilised design are available for
this step of the process. The concentrated lactobacilli
then pass to a freezedrier. Finally, the cultures are
6
Sterility and careful treatment

The careful treatment of the living microorganisms, sterility and a high separation efficiency
are prerequisite to the economical, reliable and
efficient processing. The separators from GEA
Westfalia Separator employed in this production
process are therefore equipped with hydrohermetic
product feed systems which minimise the shear
forces when the product enters the bowl and therefore
guarantee the high vitality of the cells.
7
Vaccines
Protection against germs
Vaccines are medicines which immunise human or
Live vaccines
animal organisms against diseases. The organism
One means is therapy with live vaccines. These are
to be protected is repeatedly exposed to small
germs with weakened virulence or closely related to
quantities of antigens (vaccines) or antibodies in
pathogenic germs and are therefore antigens, but
the form of a serum. This achieves immunity.
without the pathogenic effects. They are bred from

less pathogenic mutations of virulent germs, which
are suitable for the production of vaccines.
Process of vaccine manufacturing

When a suitable virus strain has been chosen, it is
isolated in ampoules and stored at -192 C in liquid
nitrogen. Breeding is then conducted starting with
the pre-fermenter and continuing in the main
fermenter. The fermentation process is supplemented
by a nutrient solution. The nutrients are dissolved
in the nutrient tank and added to the fermentation
process after filtration. The cells are then separated
from the surplus by centrifuging. The raw
vaccines pass into the mixing vessel, where their
immunogenity is increased by the addition of
adjuvants, stabilisers and preservatives.
Live vaccines
8
Sera
In serum therapy, the infected organism is
supplied with the sera produced with the antibodies
of immunised individuals. Sera are gained by
multiplying bacteria in a suitable nutrient solution.
The serum produced during fermentation is excreted
by the cells into the fermentation solution. The serum
is isolated by separating the biomass in centrifuges
and by further stages of processing in the clarification
phase.
An aseptic process is essential in the production of
vaccines and sera.
Sera
9
Example insulin
Hormones
Separation technology for human medicine
Hormones are chemical messengers which have a
Diabetes
regulating effect on the metabolism and organ
Diabetes is a metabolic disorder. Diabetics can no
activity. In collaboration with the nervous system,
longer adequately utilise glucose, which is conveyed
they co-ordinate all bodily functions. A complicated
by the blood to all cells of the body. The hormone
control mechanism ensures a harmonic interaction
insulin has a key function in this. Amongst
of the bodily functions. The separation technology
other functions, it operates as a door opener for
of GEA Westfalia Separator plays an important part
glucose molecules when they enter cells. Around
in the production of hormones, e. g. insulin.
150 million people worldwide now suffer from this

metabolic disorder. They must inject supplementary
insulin daily to prevent serious cardiovascular or
renal diseases.
In the service of human medicine

Separators from GEA Westfalia Separator play an
important part in the production process. Nozzle
separators operate in the depicted process, in which
the solid material is extracted continuously in a
constant concentration. The biosynthetic production
of human insulin is conducted by bacteria or yeasts.
10
After fermentation, or the conversion of the chemical
How sugar metabolism works
raw materials by the micro-organisms, the biomass

is extracted by a nozzle separator. In further stages,
The pancreas excretes
the active ingredient is washed and concentrated.
insulin into the blood-stream.
GEA Westfalia Separator machines are also employed

in the succeeding crystallisation stages, for example
Westfalia Separator hycon, chamber separators and
self-cleaning separators.
Glucose,
blood sugar.
Insulin helps to
convey glucose into
the cells: it opens
the cells.
Glucose is oxidised in
the cells to generate
energy.
11
Extracellular products
Inclusion bodies products
Pharmaceutical Proteins
Genetically modied bioproducts
Biotechnological processes can be characterised

as processes employing genetically modified
micro-organisms. These are able to produce
biological products which they would never have
created in their natural form. The modified DNA
chain and therefore the genetically manipulated
heredity factor is multiplied by fermentation of
the micro-organisms. The DNA chain with the
modified gene and the substances which it produces
develop simultaneously. The desired cell products
may be contained intra or extracellularly.
12
Intracellular products
After fermentation, the micro-organisms are extracted
Extracellular products
Intracellular products
and inclusion bodies
by continuously operating separators. To increase the
In intracellular processes, it is differentiated whether
yield, the solid material is washed and extracted again
the desired product is contained in the intracellular
by centrifuging. The clarified phases of the two stages
liquid or in so-called inclusion bodies. In contrast to
are mixed and fed to further stages of the process. All
extracellular bioproduction, the clarified phase leaves
material streams leaving this enclosed process
the process here and the biomass is processed. The
must be sterilised at at least 121 C. To keep the process
washed and concentrated biomass is homogenised,
as simple as possible, the biomass is killed directly after
i.e. the cells are broken down and the intracellular
fermentation in the fermenter either by heat or
liquid and the inclusion bodies are released. These
by chemical methods. Completely enclosed, steam
are separated from the cell fragments, washed and
sterilised centrifuges are employed in this process and
concentrated in further stages of the process by
can be connected to the other equipment in a sterile
centrifuges from GEA Westfalia Separator. For
manner.
intracellular products gained from the cell liquid,

the solids are extracted by continuously operating
separators.
13
Mammalian Cell Cultures

Cultures of the future
The cultivation of mammalian cell cultures

is becoming increasingly interesting for the
pharmaceutical industry. With these cells, proteins
can be produced in their effective form (quartiary
structure). In comparison with production by
micro-organisms (bacteria / yeasts), downstream
stages of the process can be substantially reduced.
In addition, risks such as infections in the
production of human proteins can be avoided.
Optimisation of the production process

In this process, particular attention must be paid to
the effects of extraneous influences such as the shear
forces on the behaviour and productivity of the
cells. Due to this circumstance, the machines were
optimised to reduce the shear forces on the cells.
This process is therefore gaining significance for
industry.
The hydrohermetic inlet developed by GEA
Westfalia Separator reduces the shear forces to a
minimum. This has been tested and published in
cooperation with the University of Bielefeld. Typical
cell cultures which are processed are CHO, BHK,
hybridoma and insect cells.
14
15
Human Blood Plasma Fractionation

Progress with blood
Blood is a special liquid. Is there actually anything
Valuable: plasma proteins
more valuable? The basis of all human life is
Fractionation is the separation of the proteins in the
also the foundation for a globally operating
plasma phase by physical and chemical processes.
industry. Whereas state institutions and aid
They are based on changes in the three parameters
organisations generally use and pass on whole
temperature, alcohol concentration and pH value,
blood, many industrial companies have specialised
which affect the solubility of the proteins in water.
in fractionation. Therapy with blood components
Human blood consists of a red phase and the clear
to explicitly combat numerous illnesses long ago
plasma phase. The red phase, about 40 percent of the
developed from simple blood transfusions.
blood, is separated by special centrifuges in the donor

bag. The plasma is deep frozen after extraction and
is processed by fractionation equipment. Only
about 5 percent of the plasma consists of the valuable
components, which must be fractionated. The
remainder is water and electrolytes.
16
Therapy with blood components

Many valuable substances can be extracted from the
proteins. The cryoprecipitate, the clotting preparation
Factor VIII concentrate and the prothrombin
complex (PPSB) can be gained from the fresh plasma
straight after thawing. The remaining plasma then
passes to the ethanol fractionation by the Cohn
process, where the individual fractions such as
fibrinogen, gamma globulin, aplha and beta
globulin and albumin are precipitated. The
plasma protein particles are used to prevent and treat
bleeding, to control bleeding during operations, for
various infectious diseases, for protein deficiency,
malnutrition and to increase the proportion of blood
plasma. After fractionation, the proteins are treated
by various specific methods before they are available
for clinical purposes.
Demands on the separating technology

Fractionation by the Cohn process is conducted
by reliable separators with cooled bowls and
housings. The maintenance of a temperature range
of 3 to 6 C is important for the process.
Chamber separators of type BKA/BKB are employed
for this purpose.
The separators of the latest generation are selfcleaning separators of the Westfalia Separator hycon
type (BSH 30), with which manual handling of the
solids is no longer necessary (see page 28).
17
Antibiotics and Vitamins

Optimised processes for more efciency
Vitamins protect life
Antibiotics for defence

Antibiotics are substances produced by fungi or
Separators are very well suited to the production of
bacteria, small amounts of which affect the growth
vitamins. Vitamins are organic compounds which
of other micro-organisms. At about 13 percent of the
fulfil vital functions. The human body cannot
total consumption of medical preparations, antibiot-
produce them itself, or only in very small amounts.
ics have the largest market share in medicines. Due
There are a total of thirteen different vitamins, which
to the significant improvements in the processes and
differ both chemically and functionally and can
the excellent economy, the pharmaceutical industry
therefore not substitute each other. Due to their
increasingly employs extraction with extraction
transport routes in the body, vitamins are divided into
decanters to produce antibiotics. Suspensions with a
water-soluble and fat-soluble vitamins.
high solid content can be simply processed with these

and the continuous direct extraction makes
Detailed information can be found in the Technical-
filtration superfluous. Losses of valuable materials
Scientific Documentation from GEA Westfalia
are avoided and a high total yield of up to 98 percent
Separator on the subject of extraction.
is achieved. Because the fermentation broth is not

diluted by the filter washing water, the infection
hazard and the solvent consumption are reduced.
18
Separators for Pharmaceutical Biotechnology

Machines for all applications
GEA Westfalia Separator offers an extensive selection
smallestnozzle separator with Westfalia Separator
of separators for biotechnology with varying
viscon technology right up to the largest steam-
production capacities and designs, from the
sterilizable centrifuge in the world the CSE 170.
Machine type
(pilot and production scale)
Product throughput (depending

Applications
on the product and process in l/h)
Self-cleaning separators
PSC 6
50 150
PSC 15
250 400
PSC 20
500 1000
PSC 35
1000 2000
PSE 80
2000 4000
PSE 170
3000 8000
PSE 200 / PSE 300
5000 15,000
Mammalian cell cultures,

starter cultures, enzymes,
pharmaceutical proteins,
hormones
Steam sterilised, self-cleaning separators

CSC 6
50 150
CSC 15
250 400
CSC 20
500 1000
CSE 80
2000 4000
CSE 100
3000 8000
CSE 170
5000 10,000
Aseptic processes, vaccines and sera,

starter cultures,
pharmaceutical proteins,
mammalian cell cultures,
hormones
Separators with Westfalia Separator viscon nozzles

CFC 15
800 2000
CFA 65
3000 10,000
CFE 300
9,000 18,000
Enzymes, pharmaceutical proteins,

hormones, starter cultures
Chamber separators
PKB 6
100 300
PKB 25
500 1500
BKA 28
300 600
BKB 45
500 1000
Hormones, pharmaceutical proteins

Human blood plasma fractionation
Hyperconcentrators Westfalia Separator hycon

PSH 30
500 1500
CSH 30
500 1500
BSH 30
500 1500
Machine type
(lab scale)
Product throughput (depending

Applications
on the product and process in l/h)
Hormones, pharmaceutical proteins

Human blood plasma fractionation
Solid wall bowl separators

FwwTC 1
up to 100
Research establishments and

laboratories
20 400
Research establishments and

laboratories
Self-cleaning separators
Pathfinder
PSC 1 / PSC 5 / PSC 8
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Hydrohermetic Inlet
Gentle product feed
Gentle and careful handling of the product is

extremely important in biotechnology to achieve
a high degree of vitality and protein activity
and to minimise changes. To feed all fluid
products carefully into the rotating bowl, all
separators from GEA Westfalia Separator for
the pharmaceutical sector are equipped with a
hydrohermetic inlet.
This inlet system prevents shear forces when the
product enters the bowl. The product is introduced
beneath the level of the liquid. It allows the level of
the liquid to reach the axis of rotation, beneath which
the product is gently introduced into the filled bowl
and accelerated. The hydrohermetic inlet, developed
and patented by GEA Westfalia Separator, has been
successfully tested on animal cell cultures and
published by the University of Bielefeld.
20
Westfalia Separator viscon

Gentle discharge of solids no problem
High mass flow

rate at the inlet
Low mass flow

rate at the inlet
Great advances have been made in recent years in the

field of centrifuging for concentration with nozzle
separators. With the development of the viscositycontrolled nozzle (Westfalia Separator viscon), the
inconvenient adjustment of the separator parameters
(ejection time) to changing inlet conditions has
become unnecessary. This achieves constant solid

discharge concentrations. The nozzle separators
of the HF and CF series represent the latest standard
of technology in the field of the treatment of starter
cultures, hormones, pharmaceutical proteins etc, last
but not least due to Westfalia Separator viscon.
Increased survival rate

In contrast to conventional nozzle separators, the
nozzles of the Westfalia Separator viscon system are
not located at the edge of the bowl, but at a smaller
circumference in the bowl top. Pressures of up to
250 bar prevail at the periphery of the bowl, whereas
the pressures are substantially lower at the centre of
the bowl. This means that the separated cells are
subjected to much lower shear forces. The introduction
through the hydrohermetic inlet and the discharge
through the Westfalia Separator viscon nozzles
increase the activity of the separated cells. The result:
the end product is more valuable and can be employed
more economically.
21
Ejection with
Westfalia Separator hydrostop
Extremely fast, precise and exible
seconds
With the Westfalia Separator hydrostop system,
ensures that even small volumes from 1.5 to 2 litres can
GEA Westfalia Separator has provided an ejection
be ejected reproducibly with an error margin of less than
system which can be adjusted precisely and
10 percent. This innovative technology allows precise,
reproducibly to specific requirements with regard to
fast ejection and therefore substantially increased and
the concentration of solids. This patented ejection
higher quality yields.
system makes it possible to optimise the ejection

sequence to the shortest time. The Westfalia Separator
hydrostop system reduces the actual ejection time to
less than 1/10 of a second and allows partial ejection
every thirty seconds.
Extremely precise even

with the smallest volumes
The great disadvantage of older ejection systems was
that they were substantially slower and less precise.
The volume and thereby the concentration of the
solids fluctuated widely. No form of control was
possible. The Westfalia Separator hydrostop system
22
Ejection with Metering Pistons

Precisely metered discharge volumes
The fundamental idea of the control system is to inject
opening water valve has been operated, the air pressure
a precisely metered volume of opening water with a
applied to the piston of the metering device injects the
metering system for partial ejection. Precise ejected
adjusted volume of water into the opening chamber.
quantities can be achieved in this way. The advantage
The air pressure for the metering device should be
in comparison with the Westfalia Separator hydrostop
4 4.5 bar. A pressure converter installed in the
system is the low required operating water pressure
metering device ensures correct ejection, overcoming
of just 1.5 bar.
the resistance of the piping, valve and injection

chamber.
In the pharmaceutical industry, high-purity water from

ring systems is often employed as the operating water.
Pressures of 1.5 to 2 bar usually prevail here. For this
reason, separators from GEA Westfalia Separator with
pneumatically-operated external metering pistons have
a proven track record. The volume of opening water can
be varied with an adjusting screw. The metering device
is filled with water through the inlet valve.
Compressed air is then injected through the valve into
the lower chamber of the metering device. After the
23
Steam Sterilising SIP

Cleaning Capability CIP
Securely sterile and clean
In some processes, e.g. in the production of vaccines
for cooling and blanketing until the next production
and sera, a strictly aseptic process is required. The
run. Sterilisation prevents cross-contamination of
separator must not only be easy to clean, but is also
different fermentation products which are processed
a part of a sterile, completely enclosed system.
by the same separator. It also prevents toxic bacteria
Apart from guaranteeing the agreed performance
or living germs from escaping to the exterior and
parameters, GEA Westfalia Separator also grants a
endangering people (biocontainment). This has also
so-called sterile guarantee on the employed sterile
been proven and published by the UCL (University
separators.
of London).
A validation of the sterilising capability of a separator
Absolutely clean with CIP
package unit according to the FDA specifications
Chemical CIP cleaning (CIP = cleaning in place) cleans
(Food and Drug Administration) was tested
process lines without the need to dismantle or open
successfully and certified by the Gesellschaft fr
individual machines. Apart from hot water,
biotechnologische Forschung (GBF) in Brunswick.
2 percent sodium hydroxide solution at a temperature
This concept has proven favourable in around
of up to 80 C is used as the cleaning liquid. This is
500 steam-sterilised separators installed world-wide.
circulated until all organic sediments have been

dissolved. 0.5 percent nitric acid solution at a
Sterile with steam
temperature of up to 80 C is used to dissolve
For example, this applies to our self-cleaning disc
anorganic sediments. The last stage of the CIP chain
separators with hydrohermetic inlets in a special
is rinsing with high-purity water.
steam-sterilised design. Sterilising is conducted with

the separator stopped with hot steam under pressure
at a temperature of over 121 C. The sterilising period
is dependent on the type of bacteria and the cell count.
After sterilising, the separator is filled with sterile air
24
Good design
Automatically safe
Apart from the specified steps of cleaning, a good
GEA Westfalia Separator not only supplies
machine design is very important. This particularly
centrifuges, but also fully automatic CIP systems. The
includes a good draining capability, the prevention of
cleaning cycle is controlled by a programmable logic
dead spaces, easily cleaned, smooth surfaces and an
controller. The program sequence for cleaning can be
optimum wetting of the surfaces in contact with the
adapted according to the local requirements. The
product by the CIP media. GEA Westfalia Separator
volume of cleaning agents is metered by the installed
achieves this by installing spray nozzles at
pumps. A conductivity sensor adjusts and monitors
different points in the separator and ensuring the
the concentrations of the media in the respective
wetting by an uranine test, the employment of
cleaning circulation systems.
separators and system components with little dead

space such as laser-welded lugs and diaphragm valves,
surface roughness of Ra 0.8 m or better and a
minimum pipe inclination of < 2 percent.
25
Westfalia Separator hycon

Design for clean room applications
When separators are installed in clean rooms,
are located apart from each other. This so-called
special attention must be paid that no particles are
two-chamber concept is implemented by the
emitted to the surroundings and that the machinery
suspended bowl and solids discharge in the clean
can be easily cleaned. At GEA Westfalia Separator,
room. This precludes contamination of the process
this is achieved by direct frequency converter drives
chamber by the drive equipment.
(no centrifugal friction clutches), stainless steel

control cabinets and the integration of machine
Economical clean room conditions
components such as pilot valves and pressure
The Westfalia Separator hycon achieves the highest
reducing valves in a valve cabinet. The latest
concentrations of solids in an aseptic process. It
development by GEA Westfalia Separator is the
unifies the advantages of chamber separators
design as a two-chamber concept with Westfalia
and self-cleaning separators, thereby completely
Separator hycon.
fulfilling
the
high
requirements
of
the
pharmaceutical industry. The hermetic isolation of
Two-chamber concept
the product-contacting and the mechanical sections
To achieve a sterile process, the drive section (drive
allows the user to create economical clean room
system and motor) and the process chamber (bowl
conditions. A sterile process is also achieved by a
and solids discharge) are sealed hermetically from
fully enclosed, steam-sterilised system. The required
each other by gas-lubricated slide ring seals. The
careful handling of the product is conducted by the
design is such that the respective components
hermetic inlet and the gentle draining of the bowl at
26
reduced speed. To achieve a high quality of the end
designates the documented proof of the execution
product, the sanitary equipment of the process
and functionality of a machine. Validation refers to
chamber is executed in the highest surface quality.
the reproducible, reliable setting of the processes. In
Due to the suspended vessel concept, solids handling
this, it is particularly important to work with
adapted by the customer is possible. This new
qualification plans and documents approved by
centrifuge system ensures a consistently high product
the user. Within the machine qualification,
quality under economical operating conditions.
GEA Westfalia Separator can execute the design

qualification (DQ), installation qualification (IQ) and
Documented qualication
operating qualification (OQ) in the course of the FAT.
Guidelines have been laid down at an international
If requested, the OQ can be conducted in the course
level of how and under which conditions medical
of the SAT, with support at the first production.
preparations must be developed and manufactured

to ensure the high quality of the products and
thereby their consistent effects. These guidelines
are designated Good Manufacturing Practice (GMP).
Strict compliance with these is the highest dictate of
our daily work. As stipulated by GMP and other rules,
the qualification and validation of pharmaceutical
machinery have a high priority. Qualification
27
Special Separators for

Low-temperature Applications
Always keep cool
1
2
3
4
5
6
7
8
9
10
11
12
In certain processes, the temperature of the product
Inlet
Outlet
Centripetal pump
Hood cooler inlet
Hood cooler outlet
Frame cooler outlet
Outer removable liner
Frame cooler inlet
Bowl cooler outlet
Bowl cooler inlet
Inner removable liner
Bell-shaped insert
heat created by air friction at the outer bowl, a frame
must not rise or may rise only slightly, for
upper section cooler which extracts the heat of the
example in human blood plasma fractionation using
cooling medium from the direct bowl cooler in
the Cohn process. This process is characterised by
the upper frame and a hood cooler, which extracts
the successive pre-cipitation of different blood
the heat from the bowl top and the lock ring. The
proteins in the negative temperature range. In the
saline cooling solution introduced into the cooling
development of the chamber separator for this
chambers has a temperature of up to -20 C, so that
process, the dissipation of the individual amounts
the outer surfaces of the separators are completely
of heat created in the separator was examined
iced during operation. With this system, a controlled
and new cooling methods were employed. This
product temperature can be achieved with a tolerance
experience has also been applied in the new
of +/- 0.3 C.
development of the Westfalia Separator hycon.
Westfalia Separator hycon: the latest

centrifuge technology
Chamber centrifuges:
hundreds in operation
The latest tendency in human blood plasma
Fractionation by the Cohn process is executed by
fractionation is the enclosed handling of the solids.
reliable, cooled chamber centrifuges. These BKA and
A good example of this is the hyperconcentrator
BKB separators operate in performance ranges from
Westfalia Separator hycon with the two-chamber
60 to 1000 l/h. They have long become established
concept (see page 26). It fulfils the highest sanitary
world-wide and have proved their worth in over 350
and hygiene requirements of a machine built to GMP.
applications for human blood plasma fractionation.
A special feature for low-temperature applications,
The compliance with a narrow temperature range of
such as human blood plasma fractionation, is the
-3 to -6 C is important for the process. In the clarifying
liquid nitrogen cooling of the bowl. Apart from the
separators of series BKA and BKB, this is achieved by
bowl cooler, the hood and solids container coolers
triple cooling: a direct bowl cooler which extracts the
ensure adequate heat extraction. It is also possible to
28
eject the solids into so-called endless bags for further

processing.
Thermal balance under control

The bowl schematic shows the main effective flows
of heat. Q in 1 is the amount of heat introduced into
the bowl by the air friction at the outer surface of the
bowl. Q in 2 is the braking effect on the bowl caused
by the inflow and outflow of the cooling liquid. Q out
1 is the amount of heat extracted by the bowl cooler.
Q out 2 is the amount of heat extracted by the frame
cooler and Q out 3 is the amount of heat extracted by
the hood cooler. The bar diagram shows the results
of measurements in a separator type BKA 28 with a
7.5 kW motor. The heat balances were calculated
under constant conditions. The left bar shows the
main amounts of introduced heat. The right bar
indicates the amounts of heat which can be extracted
at the lowest temperature of the cooling medium
(-20 C). It can be seen that controlled product
temperatures can be adjusted and that cooling
can even be achieved under certain conditions with
this type of separator. Similar heat balances can also
be realized with the hyperconcentrator through
targeted implementation of these findings in the
conceptual design of the Westfalia Separator hycon.
29
Westfalia Separator capitalcare

Maximum Process Efficiency, Installation
Availability and Budget Security
Westfalia Separator capitalcare combines decades of service experience for mechanical
separation technology.
Wherever separating technology tasks have to be car-
Training provided on site or in the modern training
ried out in metallurgy and the production of metal
centre of GEA Westfalia Separator ensures that the
concentrations: Westfalia Separator capitalcare
customers employees receive training in the proper
assures comprehensive services right from the very
handling of the high-tech installations. This provides
beginning. In close cooperation with the customer,
additional safety.
solutions are identified to meet their needs.
Authorized workshops worldwide

The partners benefit not only from traditional
And if problems occasionally occur or if a spare part
ser-vices such as inspection, maintenance, original
is required at short notice, the specialists are able to
spare parts and repair work provided by the original
attend to the customer quickly. This is ensured by a
manufacturer; they also benefit from pro-active
global network with more than 50 sales and service
solutions which avoid risk, e.g. online and offline
companies as well as 60 further sales partners.
monitoring with Westfalia Separator wewatch.
Authorized workshops are able to service every

location in the world at short notice.
Accompanying modernisation or upgrading to stateof-the-art technology also offer the option of boosting
performance as required.
30
Maximum
This advantage is particularly important for mine

operators who often work in remote locations.
Absolute
Westfalia Separator capitalcare accordingly makes
availability
budget reliability
Permanent efficiency
for maximum process efficiency and installation

availability as well as budget security. And these
benefits are provided throughout the entire life cycle
of the entire installation.
In addition to traditional
services such as maintenance
or repair, Westfalia Separator
capitalcare also provides
solutions which avoid risk and
with which the installation
availability can be pro-actively
assured.
Service from the original manufacturer:

Service engineers quickly on site
Extensive service network
Risk avoided by service provided by
the original manufacturer
Pro-active solutions which avoid risk
Upgrading to boost performance
Staff training
31
Beverage Technology
Dairy Technology
Renewable Resources
Chemical / Pharmaceutical Technology
Marine
Energy
Oilfield
Fluids & Water
Engineering
Second Hand Machinery
Cross-Flow Filtration
with Ceramic Elements
Original Manufacturer Service
The information contained in this brochure merely

serves as a non-binding description of our products
and is without guarantee.
Binding information, in particular relating to capacity
data and suitability for specific applications, can only be
provided within the framework of concrete inquiries.
Printed on chlorine-free bleached paper
www.kabutz.de
9997-8203-030/0409 EN
Printed in Germany
Subject to modification
Mechanical Separation

Werner-Habig-Strae 1 59302 Oelde (Germany)
Phone +49 2522 77-0 Fax +49 2522 77-2828
ws.process@geagroup.com www.westfalia-separator.com

Pharmaceutical Biotechnology 9997 8203 030

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Pharmaceutical Biotechnology

Downstream Processing with Centrifuges and Package Units

Separation. Solution. Success.

Mechanical Separation / GEA Westfalia Separator

Quality in its Purest Form

Aseptic process management, optimum cleaning

production processes and products. A critical

factor underlying the success of the company in

pharmaceutical biotechnology is its ability to

product treatment, ecient recovery of active

swiftly translate new developments into marketable

ingredients and reliable scale-up the require-

ments of pharmaceutical biotechnology are high.

the complex requirements of biotechnological

With separators designed specically for this

processes. The basis for this is decades of experience

sector, GEA Westfalia Separator stands for reliable

in the construction and production of separators

compliance with these requirements.

for the pharmaceutical industry, picking up on

new research ndings and the implementation of

the latest design and production processes. Using

Oelde, Westphalia in 1893. Since then, the company

has been instrumental in the advancement of

developed numerous innovative improvements to

mechanical separation technology. Today, it is a key

separating processes and brought them to market

technology in the recovery of active pharmaceutical

world-wide by applying rst-class engineering.

ingredients with substantial potential for optimising

Efcient, reliable and economical

Enzymes are complex organic protein compounds

Production of extracellular enzymes

located in every living cell, where they are produced.

Separators and decanters from GEA Westfalia

They accelerate organic processes such as the

Separator are predestined for the optimum treatment

breakdown of starch, protein, fat or sugar as

of washing powder enzymes. Carefully purified and

catalysts, i.e. without being expended themselves.

sterilised air is injected into a fermenter equipped

These valuable proteins are known to industry

with an agitator. The air bubbles are distributed

as esteemed helpers. The separators and

in the nutrient solution, which is composed of

decanters from GEA Westfalia Separator ensure

carbohydrates, protein, growth agents and nutrients.

that the intracellular and extracellular enzymes are

This is sterilised, heated to an optimum temperature

separated undamaged and in high concentrations.

and then inoculated with the purified culture of a

Production of intracellular enzymes

nourish themselves by converting the substances

Glucose isomerase is an example of an enzyme which

and simultaneously produce the enzymes. These

converts glucose into fructose and is highly

are then excreted to the fermentation broth. After

significant in the starch industry. The enzyme is

fermentation, the microorganisms are separated by

produced and remains in the cells of the employed

adding a flocculent and centrifuging with separators

micro-organisms. To process it, the liquid phase of the

and decanters. Succeeding stages of washing and