Stax™ mAx Clarification Platform product photo Primary L

Stax™ mAx Clarification Platform

Robust, high performance cell culture clarification

The Stax mAx clarification platform is a single-use, robust, depth filtration solution for the economic clarification of monoclonal antibody cell cultures without the need for centrifugation or process additives.

The filtration stages are optimized to maintain performance as cell density and viability change. This robust performance minimizes the impact of process variability between batches and delivers a platform that works across a wide range of cell cultures.

The platform scales directly with a range of formats and sizes suitable for bench-top testing up to large-scale clinical production. Whatever your process volume the Stax mAx platform assures high throughput and filtrate quality and delivers mAximum flexibility, performance and simplicity in a small footprint to meet all your clarification needs.



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概要

Robust, high performance cell culture clarification

The Stax mAx clarification platform is a single-use, robust, depth filtration solution for the economic clarification of monoclonal antibody cell cultures without the need for centrifugation or process additives.

The filtration stages are optimized to maintain performance as cell density and viability change. This robust performance minimizes the impact of process variability between batches and delivers a platform that works across a wide range of cell cultures.

The platform scales directly with a range of formats and sizes suitable for bench-top testing up to large-scale clinical production. Whatever your process volume the Stax mAx platform assures high throughput and filtrate quality and delivers mAximum flexibility, performance and simplicity in a small footprint to meet all your clarification needs.

用途

What is the Stax mAx platform?

The platform consists of two double-layer HP-series depth filtration grades, PDP8 plus PDE2. These combine to create a 4-layer depth filter system. Stage 1 uses coarse primary clarification filter grades to deliver consistent, high throughputs and Stage 2 adds finer grades to provide high filtrate clarity.

Optimized for cell densities or up to 35 x 106 cells/mL and for culture turbidity of up to 3000 NTU this robust performance makes the Stax mAx platform the ideal solution delivering economy, scalability and simplicity across a broad range of cell cultures.

How does the platform perform?

The combination of PDP8 and PDE2 depth filter sheets maintains a high throughput even as the cell density increases and viability decreases. This results in a reduction in the number of capsules required per batch by 25 to 50% when compared to single stage, double layer HP-series depth filtration systems.

This robust, high throughput ensures an economic depth filtration solution can be achieved even with large process volumes. When selected the platform performance is resilient against natural batch-to-batch variations in cell culture characteristics which would traditionally lead to a risk of incomplete harvesting due to premature filter blockage

Scalabilty

The Stax mAx platform depth filter grades (PDP8 and PDE2) are each available in a range of formats from process development through to scale-up and full-scale systems. The high throughput maintains a small footprint as your process scales.

 
Typical
Volume
Format Filtration
Area
100 – 300 mL Supracap™ 50
capsules
22 cm2
1 - 10 L Supracap 100
capsules
0.025 - 0.1 m2
25 - 300 L Stax system capsules 0.25 - 3 m2
50 - 500 L 0.5 - 5 m2
100 - 1000 L 1 - 10 m2
 
仕様
 
Materials of Construction Supracap 50 Capsules Supracap 100 Capsules Stax Capsules
Capsule shell Glass filled polypropylene Glass filled polypropylene Glass filled polypropylene
Manifold assemblies -- -- Glass filled polypropylene
Internal module Polypropylene Polypropylene Polypropylene
Gasket Silicone Silicone Silicone
Depth filter media Cellulose Cellulose Cellulose
 
For further information regarding extractables data and certifications for the capsules and manifolds please reference the Stax platform validation guide USTR 2528

 
Maximum Operating
Pressure
3 bar (44 psi) at 40 °C 3 bar (44 psi) at 40 °C 3.5 bar (50 psi) at 25 ºC
1.0 bar (14.3 psi) at 60 ºC
Maximum Differential
Pressure
1.5 bar (22 psi) 1.5 bar (22 psi) 2.4 bar (35 psi) at 25 ºC
Maximum Operating
Temperature
40 °C 40 °C 60 °C
Sterilization
Autoclaving
1 x 30 minute at 125 °C 1 x 60 minute at 125 °C 2 x 60 minute at 125 °C
Inlet / Outlet
Connections
Luer 13 mm (½ in.) hose barb 25 mm – 38 mm (1 – 1½ in.)
sanitary flange
Filtration Area 22 cm2 5 in.       0.025 m2
10 in.     0.05 m2
20 in.     0.10 m2
Small         0.25 m2
Medium      0.5 m²
Large         1.0 m²
 
Other configurations available. For further information, contact your local Pall office or distributor
型式

Supracap 50 Capsules

 
Description Details Part Number Surface Area
Stage 1 Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
SC050PDP8 22 cm2 (3.41 in2)
Stage 2 Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
SC050PDE2 22 cm2 (3.41 in2)
 
Luer-lock inlet, outlet and vent connections

Supracap 100 Capsules

 
Description Details Part Number Surface Area
Stage 1 5 in.: Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
NP5LPDP86 0.025 m2 (0.27 ft2)
Stage 2 5 in.: Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
NP5LPDE26 0.025 m2 (0.27 ft2)
Stage 1 10 in.: Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
NP6PDP86 0.05 m2 (0.54 ft2)
Stage 2 10 in.: Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
NP6PDE26 0.05 m2 (0.54 ft2)
Stage 1 20 in.: Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
NP7PDP86 0.10 m2 (1.08 ft2)
Stage 2 20 in.: Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
NP7PDE26 0.10 m2 (1.08 ft2)
 
6 to 13 mm (½in.) single hosebarb inlet and outlet connections

Stax Capsules*

 
Description Details Part Number Surface Area (m2)
Stage 1 Small : Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
SXSPDP8402SP 0.25 m² (2.70 ft²)
Stage 2 Small : Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
SXSPDE2402SP 0.25 m² (2.70 ft²)
Stage 1 Medium : Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
SXMPDP8404SP 0.5 m² (5.38 ft²)
Stage 2 Medium : Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
SMXPDE2404SP 0.5 m² (5.38 ft²)
Stage 1 Large : Media grade PDP8 6 – 30 µm, PDP8 media
(1/pkg)
SXLPDP8408SP 1.0 m² (10.8 ft²)
Stage 2 Large : Media grade PDE2 0.2 - 3.5 µm, PDE2 media
(1/pkg)
SXLPDE2408SP 1.0 m² (10.8 ft²)
 
* For Stax manifold and chassis ordering information, please refer to Pall document reference USD2590b
産業分野
Depth Filtration