エンフロン® II フィルター

Sterilizing-Grade Gamma-Compatible Gas Filters for Single-Use Systems

Offered in a range of formats, Emflon II sterilizing-grade membrane filter capsules are ideal for use in a wide of range of single-use air, gas, and vent filtration applications within the pharmaceutical and biotechnology industries, including:

  • Single-use biocontainers
  • Single-use bioreactors
  • Single-use filling operations
  • Protection of single-use liquid filters during PUPSIT

Superior Performance

Emflon II filter capsules feature 0.2 µm-rated validated sterilizing-grade membrane and are manufactured using gamma irradiation-tolerant materials, ensuring the protection of drug products and cell cultures from adventitious viral and bacterial contamination in single-use installations from upstream to final formulation and fill.

Benefits

  • Highly retentive PVDF membrane for sterility assurance
  • Gamma-irradiatable, autoclavable, or available pre-sterilized for maximum convenience
  • High flow rates associated with low differential pressure facilitate the use of small filters, resulting in reduced installation and operating costs
  • Integrity testable using the bubble point test and forward flow test
  • Enhanced flexibility due to the choice of connection options

Security of Supply and Reliability of Performance

Pall manufactures the PVDF membrane used in Emflon II filter capsules. Emflon II filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Emflon II filters are validated by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2, supported with comprehensive validation data.



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概要

Sterilizing-Grade Gamma-Compatible Gas Filters for Single-Use Systems

Offered in a range of formats, Emflon II sterilizing-grade membrane filter capsules are ideal for use in a wide of range of single-use air, gas, and vent filtration applications within the pharmaceutical and biotechnology industries, including:

  • Single-use biocontainers
  • Single-use bioreactors
  • Single-use filling operations
  • Protection of single-use liquid filters during PUPSIT

Superior Performance

Emflon II filter capsules feature 0.2 µm-rated validated sterilizing-grade membrane and are manufactured using gamma irradiation-tolerant materials, ensuring the protection of drug products and cell cultures from adventitious viral and bacterial contamination in single-use installations from upstream to final formulation and fill.

Benefits

  • Highly retentive PVDF membrane for sterility assurance
  • Gamma-irradiatable, autoclavable, or available pre-sterilized for maximum convenience
  • High flow rates associated with low differential pressure facilitate the use of small filters, resulting in reduced installation and operating costs
  • Integrity testable using the bubble point test and forward flow test
  • Enhanced flexibility due to the choice of connection options

Security of Supply and Reliability of Performance

Pall manufactures the PVDF membrane used in Emflon II filter capsules. Emflon II filters are made at manufacturing sites in Puerto Rico and the United Kingdom.

Scientifically Validated

With a removal rating of 0.2 µm in liquids, Emflon II filters are validated by bacterial liquid challenge using Brevundimonas (Pseudomonas) diminuta (ATCC 19146) at a challenge level of 107 cfu/cm2, supported with comprehensive validation data.

仕様

Capsules

Format Typical Air Flow Range (Nm3/h) Maximum Operating System Pressure (Typical) (barg)1 Sterilization Conditions
Mini Kleenpak™ 20 Capsules 0 – 0.4 2.0 Gamma irradiation: maximum of 50 kGy
Autoclave: 3 x 60 minutes at 131 °C
Mini Kleenpak Capsules 0 - 5 4.1 Gamma irradiation: maximum of 50 kGy
Gamma irradiation: maximum of 50 kGy Autoclave: 3 x 60 minutes at 125 °C
Kleenpak Capsules 0 - 50 3.5 Gamma irradiation: maximum of 50 kGy
Autoclave: 3 x 60 minutes at 125 °C
Kleenpak Nova Filter Capsules
(10-inch, 20-inch, 30-inch)
0 – 300 3.02 Gamma irradiation: maximum of 50 kGy
Autoclave: 3 x 60 minutes at 125 °C
1 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
2 0.5 barg (7 psig) up to 40 °C (104 °F). If it is possible that the pressure may exceed 0.5 barg (7 psig) during operation, then a safety shield is required. The maximum pressure of 3 barg (44 psig) must not be exceeded at any time.

Quality Release Criteria

Mini Kleenpak 20 Capsules Mini Kleenpak Capsules Kleenpak Capsules Kleenpak Nova Capsules
Designed, developed, manufactured in accordance with an ISO 9000-certified Quality Management System
Process development
Manufacturing scale – cGMP
Quantitative bubble point of the membrane
Integrity testing protocol during manufacture – each filter 100% tested
Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Provided with a Pharmaceutical Certificate of Test

製品カテゴリー

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