USD 2159 AVL - Filtra

USD 2244
Pall ® SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules

SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules
Activated carbon is an inert microporous material derived from raw material such
as peat, wood, coconut, lignite or coal. Activated carbon is characterized by
millions of pores of molecular dimensions creating a large and highly adsorptive internal
surface area up to 2,000 m 2 per gram.
Activated carbon is often used for
purification and decolorization of
pharmaceutical and chemical products and
of foodstuffs. The substances responsible
for the color are removed by adsorption
unlike in bleaching processes, where the
substances are converted. As a function
of the concentration of the material to be
adsorbed, an equilibrium forms between
the phases (liquid or gas) and the surface
of the activated carbon. A further
characteristic feature of activated carbon
is the practically non-polar surface resulting
in a high affinity to the likewise mostly nonpolar
organic molecules. (For further
information see “Adsorption”)
Advantages of the SUPRAdisc AKS
Modules
• No separation of activated carbon
necessary
• Dust-free processes
• Quick and easy module change
• In-line sterilization
• No channel formatting e.g. with
activated carbon columns
• Enclosed systems in accordance with
GMP
• Highly reliable due to patented central
core adapter system
• Very low hold-up volume
• Easily scaleable due to modular design
Versions
SUPRAdisc AKS depth filter modules are
available in three versions for different
applications:
AKS 6
Applications in the pharmaceutical industry
as well as biotechnology, blood and
chemical industry
AKS 5
Applications in the pharmaceutical and
biotechnology sector
AKS 4
Applications in the API market

AKS 6
General Characteristics
AKS 6 depth filters contain a special porous
carbon in powdered form, which is mainly
responsible for successful adsorption
processes in many liquid phase
applications. Its typical pore size distribution
(ratio of micropores, mesopores and
macropores) and relatively low
hydrophobicity allows easy access for high
molecular weight molecules and additionally
specific adsorption of materials with a
molecular weight between 1 and 100 kDa
(e.g. natural colorants, humic substances,
biopolymers like PKA)*. With AKS 6 depth
filters, protein solutions (e.g. plasma
products like albumin) can be purified by
selective adsorption of PKA, because the
loss of target proteins is very small. The
more non-specific removal capabilities of
other organic impurities such as natural
colorants from protein solutions is
preserved.
The low iron and aluminium content of the
activated carbon in the AKS 6 depth filters
makes it particularly suitable for applications
such as pharmaceutical and biotechnological
processes.
PKA adsorption (%)
90
80
70
60
50
40
30
20
10
0
Competitor
AKS 6
1 2 3 4
Different PKA adsorption conditions
Endotoxin Content
AKS 6 contains < 0.02 EU/mL after 50 L/m 2
flushing with WFI (AKS 6 doesn’t contain
LAL inhibiting or enhancing substances)
Biological Safety
Certificates by NAMSA are available upon
request.
PKA Reduction
During plasma processing different
important pharmaceutical proteins are
isolated and purified under very specific
conditions, to avoid activation of the blood
coagulation system in plasma. The
production conditions have a strong
influence on the activation of the very
complex coagulation sequence. This may
lead to pharmaceutically very potent
metabolic products, responsible for
inflammation and hypotension syndromes
in patients, who are treated with these byproducts.
Figure 1 Figure 2
PKA adsorption (%)
SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules
(Activation of the blood coagulation system
in vivo is essential and mainly responsible
for healing of wounds performed by very
complex biochemical reactions in blood).
Precise control of the entire production
process is therefore essential during plasma
fractionation.
* (PKA (prekallikrein-activator) is one of the central
metabolic products and is an indicator of the quality of
the plasma production process).
Results of PKA Testing
In several investigations the AKS 6 depth
filter shows distinct advantages in the PKA
reduction compared to competitor products.
(see Figure 1). The adsorption curve
(Figure 2) additionally demonstrates a good
performance of the AKS 6 depth filter in PKA
reduction.
Taking the PKA adsorption into account, the
superiority of the AKS 6 depth filter is even
more significant. The advantages compared
to the competition is evident. The PKA
clearance is a very important application
parameter, which combines the potential of
PKA reduction in human albumin solutions
and selectivity of the adsorption process.
100
90
80
70
60
50
40
30
20
10
0
500 1000 1500 2000 2500 3000 3500 4000
PKA amount (IU/m2 Competitor
AKS 6
x 1000)

SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules
AKS 5
General Characteristics
The SUPRAdisc AKS 5 depth filter modules
has been specially developed for the
requirements of the pharmaceutical industry
(e.g. for decolorization of blood products,
glucose, solutions and antibiotics). The
carbon used in the AKS 5 meets the
requirements of the European and US
Pharmacopeia.
Applications
For decolorization of blood products such
as albumin, SUPRAdisc AKS 5 can be
successfully applied during the Cohn
fractionation process and also for the
removal or reduction of
• Hemoglobin traces
• Biliverdin traces
• Lipids
• Anticoagulants
• Detergents
In addition SUPRAdisc AKS 5 depth
filter modules are used for the filtration
of products such as
• Antibiotics
• Glucose solutions
• Enzymes
• Vitamins
The recommended flow velocities for
decolorization of albumin and other
pharmaceutical products is 100 -
200 L/m2h, for decolorization and
deodorizing of sugar solutions 350 -
400 L/m2h and for dechlorination of
water 50 - 150 L/m2h. Diagram of Albumin Production
Including Adsorption Step with
SUPRAdisc AKS 5
Separation Fraction I
Fibrinogen
▼
Separation Fraction II/III Immunoglobuline
▼
Fraction V Albumin
▼
Removal of pastes and precipitates SUPRAdur ®
50 P support sheets
▼
Filtration SUPRAdisc BIO 10
or BIO 20 modules
▼
Adsorption/Decolorization, SUPRAdisc AKS 5
PKA removal SUPRAdisc AKS 6
▼
Dialyze
▼
Ultrafiltration
▼
Sterile Filtration
▼
Filling

AKS 5
Adsorption capacity
The outstanding feature of the
pharmacopeiaen-grade activated carbon
used for depth filter modules is the very
high adsorption capacity due to the special
pore structure and the unusually high
degree of activation of the carbon. This
way the pharmacopeial requirements are
not only met but even surpassed. ( The
main criteria for pharmacopeian – grade
activated carbon is the adsorption capacity
of methylene blue).
If suspended, colloidal or emulsified
particles are removed prior to filtration, the
adsorption capacity of the SUPRAdisc
AKS 5 modules can be increased even
further, this can be carried out with Pall
prefilter systems prior to the adsorption
process step.
Extractables
SUPRAdisc modules contain very low
amounts of extractables such as aluminum,
iron etc. For further details, please contact
Pall.
Endotoxin content
AKS 5 contains < 0.02 EU/mL after 50 L/m 2
flushing with WFI (AKS 5 doesn’t contain
LAL inhibiting or enhancing substances)
Advantages of the SUPRAdisc SD
AKS5 Filter Modules
Economy
• Very economical due to high
adsorption capacity
• Low protein adsorption
Quality
• Very high purity (meets the USP/EUR
requirements)
• Very low content of extractables, e.g.
aluminium irons and endotoxins
• Very low pH-shift
SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules

SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules
AKS 4
Application for the API and
Foodstuff Industry
The filter modules containing activated
carbon (SUPRAdisc AKS 4) have been
specially developed for the requirements in
the chemical and foodstuff industries. Due
the excellent adsorption capacity, the
SUPRAdisc AKS 4 modules have proven
successful in the following applications:
• Decolorization of chemicals and plant
extracts
• Dechlorination of water
• Decolorization of silicon oils
Total Throughput of Chlorinated Water in m 3 /m 2 until Cl 2 breakthrough at specific flow
Velocities using AKS 4
Initial 250 500 750 1000
Concentration L/m -2 h -1 L/m -2 h -1 L/m -2 h -1 L/m -2 h -1
mg Cl 2 /L
* Calculated values
100 2.2 1.9 1.6 1.2
10 23 19 14 8
1 130* 100* 85 60*
Application Summary of the Different AKS Types
AKS 4 AKS 5 AKS 6
Proteins + ++ +++
Dark colorants + ++ +++
Medium colorants + ++ ++
Natural pigments + ++ ++
Pyrogens 0 +++ +
Light colorants 0 +++ +
Color precursors + +++ +
Odor compounds + +++ +

Parameters Affecting the Adsorption
Filtration Velocity
The available contact time is of significant
importance in adsorption processes. Using
SUPRAdisc AKS depth filter modules the
contact time can be varied by suitable
adjustment of the filtration velocity. Low
filtration velocities, resulting in long contact
times have a positive effect on the
adsorption capacity (Figure 3).
Temperature
The diffusion rate increases at higher
temperatures. Thus adjustment of the
adsorption equilibrium is obtained more
rapidly. However, the total amount of
adsorbable substances is higher at lower
temperatures (Figure 4). Hence, in most
cases a higher adsorptive capacity is
yielded at lower temperature provided that
the contact time is long enough for the
product in question. This basic statement,
however, is only applicable if the substance
to be adsorbed shows uniform structures
at varying temperatures. If the structure
changes, the temperature may have a
reverse effect.
pH-Value
Depending on the activated carbon and on
the different isoelectric points of the
substances to be adsorbed, the adsorption
capacities can vary considerably at different
pH- values (Figure 5). However, particularly
in regard to the pH-value, interactions
between different product substances
and/or the structure of a component are
possible. Therefore, no general statement
can be made about the adsorption as a
function of the pH-value.
Figure 3
Methylene adsorption g/m 2
250
240
230
220
210
200
Figure 4
Methylene adsorption in mg g -1
Comparison of the Methylene Blue Adsorption by
SUPRAdisc AKS 5 at Different Filtration Velocities
SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules
190
0 250 500 750 1000 1250 1500 1750 2000
Filtration velocity in L/m -2 h -1
540
520
500
480
460
Figure 5
Methylene adsorption in mg g -1
Comparison of the Methylene Blue Adsorption by
SUPRAdisc AKS 5 at Different Filtration Temperatures
440
0 10 20 30 40 50 60
Temperature in °C
1000
900
800
700
600
Comparison of the Methylene Blue Adsorption by
SUPRAdisc AKS 5 at Different pH Values
500
4 5 6 7 8 9 10 11
pH - value

SUPRAdisc AKS
Technical Specifications
Operating Characteristics*
Maximum Operating 80°C (176°F) in Polypropylene design
Temperature 160°C (320°F) in Polyamide design
Maximum Operating Pressure 2.4 bard (35 psid)
* With compatible fluids, which do not soften, swell or adversely affect the products
or its material of construction.
3
Plastic Parts of Construction of SUPRAdisc Modules
SUPRAdisc Components Polypropylene (Standard version)
Polyamide (High temperature version)
O-rings Silicone elastomer
Filter Media Configurations
Code Filter
Type
See Above Table
New York - USA
+1 516 484 5400 phone
+1 516 801 9548 fax
pharmafilter@pall.com e-mail
Portsmouth - Europe
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com e-mail
Sterilization
Steam in Place 125°C (257°F) for 30 minutes
at 0.3 bard (4.3 psid) maximum.
Nominal Dimensions
Nominal Total Length
Double O-ring 332 mm (13.1 in)
Flat Gasket 272 mm (10.7 in)
Nominal Diameter 284 mm (11.2 in) (1)
(1) Filter area codes 205, 209, 214 and 215.
(2) Filter area code 416 only.
Code Gasket
Material
410 mm (16.1 in) (2)
Code Depth Filter Mass per Unit Ash Content Extractable Ions Soluble in Acetic Acid
(For Part Number Structure)
Type Area (g/m 2 ) in % (5%) (mg/m 2 )
Part Numbering and Ordering Information
Code Module
Version
00 Standard
01 High
temperature
30 Increased
cell
distance
Code Adapter
S Double
O-ring
C Flat
Gasket
Code Filter
Area
205 0.5 m 2 (5.4 ft 2 )*
209 1.0 m 2 (10.7 ft 2 )
214 1.5 m 2 (16.1 ft 2 )**
215 1.7 m 2 (18.2 ft 2 )***
416 3.7 m 2 (39.8 ft 2 )
* Only available with double
O-ring.
** Only AKS 5 and AKS 6
*** Only AKS4
Ca Fe Al
XAK4 AKS 4 1050 13 2000 100 100
XAK5 AKS 5 1400 < 1 550 20 15
XAK6 AKS 6 1400 < 1 1000 25 10
S Silicone
elastomer
Other gaskets available on
request
Code Plastic Parts
P Polypropylene
A Polyamide (2)
(2) High Temperature only.
Visit us on the web at www.pall.com/biopharmaceutical
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Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands,
New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain,
Sweden, Switzerland, Taiwan, Thailand, United Kingdom, the United States and Venezuela.
Distributors are located in all major industrial areas of the world.
Because of developments in technology these data or procedures may be subject to change. Consequently we advise
users to review their continuing validity annually.
, Pall, SUPRAdisc and SUPRAdur are trade marks of Pall Corporation.
Filtration. Separation. Solution. is a service mark of Pall Corporation.
Part Numbers quoted above are protected by the Copyright of Pall Europe Limited.
® indicates a trademark registered in the USA.
© 2004, Pall Europe Limited.
10.2004