Pharmaceutical
Home Filtration Solution for Biopharmaceuticals Venting and Gas Filtration Gamma -irradiatable Capsule Filters
Gamma -irradiatable Capsule Filters

Cobetter gamma irradiatable capsule filters incorporated with hydrophobic PVDF membrane,features high flow rate and 100% bacterial retention ,which are specially suitable for sterile filtration of air and gas in biopharmaceutical,even in some presence of high moisture.

Features and Benefits

  • Compact design,easy to handle and installation
  • Highly-retentive for sterility safety
  • Available in multiple formats

Applications

  • Biocontainers
  • Fermentation inlet air
  • Transfer sets

Regulatory Compliance

  • Manufactured under a quality management system certified to ISO9001:2008
  • 100% Integrity tested during production and supported with a validation guide for compliance with regulatory requirements
  • Each individual element is tracked by series number for traceability and easy identification
  • Specifaction
  • Performance
  • Ordering Information

Specifications

Filter Media
Pore Size		Hydrophobic PVDF
0.2μm
Filter Structure ComponentsGamma Stable Polypropylene
Bacterial Retention

Retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC®19146)

according to ASTM F838.

Max. Temperature41℃
Max. Differential Pressure3.5 bar/ 41℃
Sterilization Method- Gamma Irradiation: 25 kGy recommend 50kGy maximum
- Autoclaved for1 cycles of 30 minutes at 135℃. (No in-line steam sterilization)
Bacterial Endotoxin<0.25EU/mL, according to LAL Test
Component Material ToxicityMeets USP Biological reactivity test for Class VI-121℃ Plastics

Ordering Information

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