USD 2758
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Powdered activated carbon (PAC) is widely used in the pharmaceutical industry for decolorization and removal of other trace impurities. The use of bulk PAC has significant drawbacks relating to the handling of bulk carbon powder, cleaning of process equipment, and time (costs) associated with carbon removal from the process. Seitz AKS immobilized carbon media alleviates these concerns by incorporating activated carbon within a matrix of cellulosic fibers. This immobilized carbon media is then coupled with a downstream filter paper to prevent carbon particle shedding downstream of the filter. Additionally, the adsorption efficiency of Seitz AKS immobilized carbon filter media is greater than an equivalent amount of bulk PAC, further reducing overall process time and increasing product yield.
Pall Seitz AKS immobilized activated carbon filter media provides a streamlined process only requiring a single step.
The feed stream is simply passed once through the filter at an appropriate flow rate to achieve the desired adsorption.
This saves time, resources, and expense. It is nearly 100% free of carbon dust so operators and the workspace are much better protected. No additional mixing, filtration, or cleaning steps are needed.
Table 1: Comparison of PAC and Seitz AKS
Immobilized Activated Carbon Media
PAC Process
Complex multiple steps
AKS Process
Streamlined single step
Improvements
Faster process
Better yields
Reduced labor
Powder addition and mixing
Flow through single pass Better adsorption
Improved yields
Faster process
Carbon powder No upstream carbon contamination distributed No/trace carbon throughout process plant downstream of module
No cleaning
Minimal downstream filtration
Dusty, difficult to handle No dust Improved health and safety
Placed into one of the three differently sized chassis, Pall’s single-use Stax AKS capsules eliminate the use of stainless steel housings which require costly cleaning and cleaning validation. Stax system chassis are designed for assembly and use by a single operator and provide a logically conceived disposable platform in which the operator can load, operate and unload in an ergonomically designed vertical orientation. With simple, straightforward and familiar features, the Stax platform eliminates the risk of error or mishap and enables greater process success.
The Stax platform has been designed to accommodate nearly all processing options. Whether you want to process:
Bottom up
Top down
Bottom in/bottom out
In series
Simply using Pall’s uniquely designed manifold kits provides complete flexibility in your process design.
Table 2: Features and Benefits of Stax AKS Systems
Features
No housing
Completely disposable
Small footprint
Intuitive design
Encapsulated design
Low hold-up volume
Benefits
Easier to use and manipulate while eliminating operator safety issues
Eliminates need for cleaning and cleaning validation
Enables use in close proximity to other equipment and reduces cost to install
Reduces operator training and increases time to acceptance
Reduces operator exposure to potential biohazards
Greater product recovery and lower post use rinse volume required than traditional modules and housings www.pall.com/biopharm
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Macro- and mesopores can generally be regarded as the highways into the carbon particle, and are crucial for adsorption kinetics. Macropores are used for the transport, and adsorption occurs in the meso- and micropores.
Small molecules, such as methylene blue, which has a molecular weight of 319.86 daltons, are mainly captured in micropores. For larger impurity molecules, other pore structures in the carbon must be available to ensure optimal adsorption. Carbon, which can capture larger molecules, tends to adsorb smaller impurities as well, whereas dedicated carbons for small molecules do not remove larger contaminants.
Table 3 provides an overview of how different AKS grades may suit an application based on their general characteristics. However, due to the various factors that may affect the adsorption process, Pall recommends scaled-down testing of several Seitz AKS filter media using Pall UpScale
SM program test kits as the most reliable way. For more information please reference Pall data sheet USD 2459 or validation guide USTR 2491.
Table 3: Typical Efficiency Characteristics of Seitz AKS Media Grades
Typical Molecular W eight
Media Grade Efficiency Characteristics of Target Contaminants
AKS 1
AKS 2
AKS 5
AKS 6
AKS 7
AKS 8
AKS 9
Ultra high efficiency
Ultra high efficiency
High efficiency
High efficiency
Ultra high efficiency
High efficiency
High efficiency
400 – 1500 Daltons
400 – 1000 Daltons
200 – 400 Daltons
400 – 1500 Daltons
400 – 1500 Daltons
400 – 1000 Daltons
400 – 1000 Daltons
Table 4: Stax AKS Capsule Configuration
Codes for Different AKS Media Grades
Media Grade Media Code
AKS 1 XAK1
AKS 2
AKS 5
AKS 6
XAK2
XAK5
XAK6
AKS 7
AKS 8
AKS 9
XAK7
XAK8
XAK9
Configuration for
Stax AKS Capsule
406
406
407
407
406
407
407
Table 5: Typical Ash and Endotoxin Level for Different Pall AKS Grades
Typical Endotoxin Level
Media Grade Typical Ash Content in % (in EU/mL)
AKS 1
AKS 2
AKS 5
< 3
< 4
< 1
< 0.12
< 0.12
< 0.06
AKS 6
AKS 7
AKS 8
AKS 9
< 3
< 3
< 2
< 2
< 0.06
< 0.12
< 0.12
< 0.12
Amount of PAC Present / Stax Capsule in Kg Media Area / Stax AKS Capsule in m²
1.45
1.40
1.45
1.05
1.30
1.40
1.62
1.62
1.45
1.30
1.30
1.40
1.62
1.62
Table 6: Dimensions and Weight of Stax AKS Capsules
Capsule Footprint
Capsule Size Diameter Height
Large 442 mm 128.8 mm
(17.4 in.) (5.1 in.)
* Post blow down
Capsule Weight
Dry
7-7.5 Kg
Wet*
< 13 Kg www.pall.com/biopharm
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Table 7: Materials of Construction
Media
Capsule shell
Filter element
Gaskets
Cellulose base and PAC
Glass filled polypropylene
Polypropylene
Silicone
For further information regarding extractables data and certifications for the capsules shells and manifolds please reference the Stax platform validation guide USTR 2528. For extractable data and certification for the Seitz AKS media please reference validation guide USTR 2491.
Table 8: Operating Parameters (1)
Maximum operating temperature
Maximum operating pressure
60 °C
3.5 bar at 25 °C
1.0 bar at 60 °C
2.5 bar at 25 °C – forward direction Maximum differential pressure
(1) Note: All pressure and temperature specifications are for Stax capsules correctly installed into Pall Stax chassis.
Table 9: Sanitization
Hot water sanitization
Post use caustic treatment
80 °C at 1 bar for 1 h
1 M NaOH at 3.5 bar for 1 h at 25 °C
Table 10: Traceability
Capsule part number laser engraved with
Media batch number
Internal sales order number
Unique serial number
Pre Release Testing
All capsules 100% leak tested.
Table 11: Chassis Dimensions
Chassis Model
SXLSC02
Footprint Size
Height Length Width
1018 mm (40.0 in.) 516 mm (20.3 in.) 516 mm (20.3 in.)
SXLSC02W
SXPSC05P
SXPSC05W
SXPSC10P
SXPSC10W
1059 mm (41.7 in.) 591 mm (23.2 in.)
1241 mm (48.9 in.) 610 mm (24.0 in.)
560 mm (22.0 in.)
610 mm (24.0 in.)
1312 mm (51.6 in.) 1150 mm (45.3 in.) 800 mm (31.5 in.)
1864 mm (73.4 in.) 610 mm (24.0 in.) 610 mm (24.0 in.)
1935 mm (76.2 in.) 1150 mm (45.3 in.) 800 mm (31.5 in.)
Table 12: Chassis Weights and Capsule Capacity
Chassis Model Weight
SXLSC02 75 Kg
SXLSC02W
SXPSC05P
SXPSC05W
SXPSC10P
SXPSC10W
75 Kg
190 Kg
192 Kg
238 Kg
240 Kg
1
1
1
1
1
Number of Stax AKS Capsules
Minimum Maximum
1 2
2
5
5
10
10
Table 13: Chassis Materials of Construction
304/1.4301 Stainless Steel 1.2
µ m / 64
µ in Ra (typical) Electro-polish
Table 14: Stax Capsules with Seitz AKS Media
Part Number
SXLXAK1406SP
SXLXAK2406SP
SXLXAK5407SP
SXLXAK6407SP
SXLXAK7406SP
SXLXAK8407SP
SXLXAK9407SP
Description
Stax capsule with AKS1 media
Stax capsule with AKS2 media
Stax capsule with AKS5 media
Stax capsule with AKS6 media
Stax capsule with AKS7 media
Stax capsule with AKS8 media
Stax capsule with AKS9 media
Table 15: Stax Chassis
Part Number
SXLSC02
SXLSC02W
SXPSC05P
SXPSC05W
SXPSC10P
SXPSC10W
Description
Pilot scale without castors
Pilot scale with castors
5 high process scale without castors
5 high process scale with castors
10 high process scale without castors
10 high process scale with castors
Table 16: Stax Manifold Kits
Part Number
SXBBM400SP
SXTBM400SP
Description
Bottom in – Bottom out
Bottom in – Top out
Conforms to Pressure Equipment Directive – Category 1 /
Module A (SXLSC02 is Sound Engineering Practice)
Outside scope of ASME VIII Div 1 Complies with Universal
Building Code (1997) – Zone 4 / Importance factor 1.25
(SXPSC*P ONLY)
* Place holder for either 05 (indicating a 5 high process scale chassis) or 10 (indicating a 10 high process scale chassis) ATEX chassis available upon request www.pall.com/biopharm
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United States
1.800.717.7255 toll free (USA)
1.516.484.5400 phone
1.516.801.9548 fax biopharm@pall.com E-mail
© 2011, Pall Corporation. Pall, , Seitz, and Stax are trademarks trademark registered in the USA. Filtration. Separation. Solution.
is a service mark of Pall Corporation.
3/11, PDF, GN11.4181
3/11, PDF, GN11.4181
USD 2758
USD 2758