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USD 2244

Pall?SUPRAdisc? AKS Carbon Impregnated Depth Filter Modules

SUPRAdisc AKS

Carbon Impregnated Depth Filter Modules

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 non-polar 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

Activated carbon is an inert microporous material derived from raw material such as peat, wood, coconut, lignite or coal. Activ ated carbon is characterized by millions of pores of molecular dimensions creating a large and highly adsorptive internal surface area up to 2,000 m 2per gram.

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

SUPRAdisc AKS Carbon Impregnated Depth Filter Modules

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 bio-technological processes.Endotoxin Content

AKS 6 contains < 0.02 EU/mL after 50 L/m2

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 by-

products.

(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

(Figure2) additionally demonstrates a good

performance of the AKS 6 depth filter in PKA

reduction.

T aking 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.

Figure 1

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 Carbon Impregnated Depth Filter Modules

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/m2 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

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

SUPRAdisc AKS

Carbon Impregnated Depth Filter Modules

Total Throughput of Chlorinated Water in m 3/m 2until Cl 2 breakthrough at specific flow Velocities using AKS 4

Initial 2505007501000Concentration L/m -2h -1

L/m -2h -1

mg Cl 2/L

100 2.2 1.9 1.6 1.21023191481

130*

100*

60*

*Calculated values

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. H owever, the total amount of adsorbable substances is higher at lower temperatures (Figure 4). H ence, 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.

SUPRAdisc AKS

Carbon Impregnated Depth Filter Modules

Figure 3

Pall Corporation has offices and plants throughout the world in locations including: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, T aiwan, Thailand, United Kingdom, the United States and Venezuela.Distributors are located in all major industrial areas of the world.

Visit us on the web at https://www.360docs.net/doc/4c11338522.html,/biopharmaceutical

New York - USA

+1 516 484 5400 phone +1 516 801 9548 fax

pharmafilter@https://www.360docs.net/doc/4c11338522.html, e-mail

Portsmouth - Europe

+44 (0)23 9230 3303 phone

+44 (0)23 9230 2506 fax

BioPharmUK@https://www.360docs.net/doc/4c11338522.html, e-mail

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.

10.2004SUPRAdisc 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.

Plastic Parts of Construction of SUPRAdisc Modules

SUPRAdisc Components Polypropylene (Standard version)

Polyamide (High temperature version)O-rings

Silicone elastomer

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)410 mm (16.1 in)(2)

(1)Filter area codes 205, 209, 214 and 215.(2)

Filter area code 416 only.

Part Numbering and Ordering Information

Filter Media Configurations

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)

Fe Al XAK4AKS 41050132000100100XAK5AKS 51400< 15502015XAK6

AKS 6

1400

< 1

1000