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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

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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!

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

Intracellular enzymes

Extracellular enzymes

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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).

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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.

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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

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GEA Westfalia Separator

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
GEA Westfalia Separator

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
GEA Westfalia Separator

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
GEA Westfalia Separator

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
GEA Westfalia Separator

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

GEA Westfalia Separator


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