1) KleanCap Gamma Irradiation Sterilizable PES Membrane Capsule Filters
Summary
Source KleanCap Gamma Irradiation Sterilizable PES Membrane Capsule Filters from MS factory for biopharmaceutical filtration where gamma-sterilized PES, low protein binding and 100% integrity testing support clean processing of cell culture media, vaccines and parenteral solutions. Available in single and double layer configurations.
Introduction
Order KleanCap Gamma Irradiation Sterilizable PES Membrane Capsule Filters from MS supplier when your biopharmaceutical process needs a pre-sterilized disposable capsule for sensitive biological fluids. The PES membrane is naturally hydrophilic and inherently gamma-radiation stable, requiring no pre-wetting agents and maintaining performance through sterilization up to 45 kGy. KleanCap G.I. capsule filters are full-size assemblies developed to meet pharmaceutical process requirements.
Who this product fits best
Biopharmaceutical plants needing gamma-sterilized capsules for aseptic processing
Buyers prioritizing low protein binding for cell culture media and biological fluids
Operations wanting single-use convenience to eliminate cleaning validation between batches
Application Notes: Typical Use Cases
Cell culture media: low protein binding preserves growth factors and serum proteins.
Media additives: sterile filtration of concentrated supplement solutions without adsorption.
Vaccine intermediates: bioburden reduction at multiple processing stages.
Large volume parenterals: final filtration before aseptic filling.
Technical Specifications
Filter Area: 0.6 m² / 10"
Capsule Integrity: Minimum burst pressure 123.5 psi (8.5 barg)
Toxity: USP Class VI 121°C plastics
Key Features
100% integrity tested
Low protein binding
Low hold-up volume
High flow rate
Multiple connection choices
Sterilizable by gamma irradiation or autoclaving
Materials of Construction
Filter Media: Polyethersulfone (PES)
End Caps: Polypropylene
Inner Core: Polypropylene
Outer Cage: Polypropylene
Sealing Method: Thermal Bonding
Food Safety Compliance
FDA 21 CFR food contact basis and EU 10/2011 expectations for materials used.
Integrity
|
Pore Size |
Min.Bubble Point |
Min.Bubble Point |
|
0.04μm |
2.3barg@22°C/IPA |
≤28ml/1.7barg |
|
0.1μm |
1.7barg@22°C/IPA |
≤28ml/1.3barg |
|
0.2μm |
3.5barg@22°C |
≤28ml/2.8barg |
|
0.45μm |
2.3barg@22°C |
≤25ml/1.7barg |
|
0.65μm |
1.6barg@22°C |
≤25ml/1.0barg |
|
0.8μm |
1.3barg@22°C |
≤25ml/1.0barg |
|
1.2μm |
0.9barg@22°C |
<25ml/0.6barg |
Typical Flow Rate, single-layer, 10"
Ordering Information
To order KleanCap Gamma Irradiation Sterilizable PES Membrane Capsule Filters, confirm membrane configuration (single or double layer), pore size, connection type, and capsule length. MS will verify and provide a formal quotation.