Emflon® II Membrane in Mini Kleenpak™ 20 Capsules product photo Primary L

Emflon® II Membrane in Mini Kleenpak™ 20 Capsules

Emflon® II filters assemblies contain hydrophobic polyvinylidenedifluoride (PVDF) membranes, which are designed for use as sterilizing filters for air, gas, and vent service in biopharmaceutical applications.

Mini Kleenpak™ 20 capsules with Emflon II membrane are compact filter capsules that provide high air flows, resist blocking in ‘wet’ applications, and provide removal of bacteria from air and gases, even in the presence of high humidity and moisture. These Kleenpak capsules are manufactured using gamma irradiation tolerant materials and offer the very highest standard of filtration security and user convenience. These filters can be integrated within gamma irradiatable or gamma sterilized complex systems such as bioreactors, manifolded disposable filter assemblies that require sterilizing vents for additional security during integrity tests, and as vents in transfer sets and on carboys.

 

Features and Benefits

  • Highly retentive Emflon II membrane
  • High flow-rates associated with low Delta P enables the use of small filters leading to reduction of installation and operating costs
  • Gamma-irradiatable or autoclavable for maximum convenience
  • Integral molded connections
  • Integrity testable using the Bubble Point test

High Quality Standards

  • Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of
    107 organisms/cm2 of filter area
  • 100 % integrity tested during manufacturing
  • Identified by a lot number with a unique serial number for complete traceability of manufacturing history and for user traceability systems
  • Filters supplied with a Certificate of Test
  • Comprehensive validation guide available for Emflon II cartridges
  • Manufactured under a Quality Management System certified to ISO 9001:2000

Biological Tests

  • Meets USP Biological Reactivity Tests in vivo, in accordance with USP Class VI plastics
    at 121 °C

Effluent Quality Tests*

  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing per 21CFR211.72 and 21CFR210.3(b)(6)
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)

* Per lot samples on rinse-up flush aliquots

Pall’s UpScaleSM Program

From drug discovery and basic research, through process development and production, Pall is the single source for all of your filtration and separation needs. Our UpScale program provides you with the scaleable filtration products and support you need to bring new drug products to market faster.



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描述
Emflon® II filters assemblies contain hydrophobic polyvinylidenedifluoride (PVDF) membranes, which are designed for use as sterilizing filters for air, gas, and vent service in biopharmaceutical applications.

Mini Kleenpak™ 20 capsules with Emflon II membrane are compact filter capsules that provide high air flows, resist blocking in ‘wet’ applications, and provide removal of bacteria from air and gases, even in the presence of high humidity and moisture. These Kleenpak capsules are manufactured using gamma irradiation tolerant materials and offer the very highest standard of filtration security and user convenience. These filters can be integrated within gamma irradiatable or gamma sterilized complex systems such as bioreactors, manifolded disposable filter assemblies that require sterilizing vents for additional security during integrity tests, and as vents in transfer sets and on carboys.

 

Features and Benefits

  • Highly retentive Emflon II membrane
  • High flow-rates associated with low Delta P enables the use of small filters leading to reduction of installation and operating costs
  • Gamma-irradiatable or autoclavable for maximum convenience
  • Integral molded connections
  • Integrity testable using the Bubble Point test

High Quality Standards

  • Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of
    107 organisms/cm2 of filter area
  • 100 % integrity tested during manufacturing
  • Identified by a lot number with a unique serial number for complete traceability of manufacturing history and for user traceability systems
  • Filters supplied with a Certificate of Test
  • Comprehensive validation guide available for Emflon II cartridges
  • Manufactured under a Quality Management System certified to ISO 9001:2000

Biological Tests

  • Meets USP Biological Reactivity Tests in vivo, in accordance with USP Class VI plastics
    at 121 °C

Effluent Quality Tests*

  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing per 21CFR211.72 and 21CFR210.3(b)(6)
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)

* Per lot samples on rinse-up flush aliquots

Pall’s UpScaleSM Program

From drug discovery and basic research, through process development and production, Pall is the single source for all of your filtration and separation needs. Our UpScale program provides you with the scaleable filtration products and support you need to bring new drug products to market faster.

规格

Materials of Construction

 
 Membrane  Hydrophobic Polyvinylidenedifluoride (PVDF)
 Capsule  Polypropylene
 

 

Operating Parameters1

 
 Maximum Operating Temperature and Pressure  2.0 bard (29 psid) @ 20°C 
 

1 In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction.

 

Sterilization2

 
 Autoclave 3 x 60 minute cycles @131°C
 

2 Warning: Pre-sterilized Mini Kleenpak filters should not be re-sterilized. Contact Pall in regards to re-sterilizing gamma irradiated Mini Kleenpak filters. Mini Kleenpak filters must not be sterilized in-situ by passing steam under pressure. Do not autoclave after use if heat labile chemical contaminants are present on the filter.

 

Nominal Dimensions

 
Housing Diameter  68 mm (2.7 in.)
Inlet/Outlet Hosebarb Length  83 mm (3.3 in.)
 

 

Nominal Effective Filtration Area

 
 20 cm2
 

 

Typical Flow Rates

 
 27 L/min at 1bard (15 psid)
 

 

Gamma Irradiation

 
 Maximum 50 kGy
 
应用
Filters - Gas
订购信息
 
Part Number Item No. of Capsules Per Box
KM5V002P2G Mini Kleenpak™ 20 Filter Capsules with Emflon® II Membrane 3
KM5V002P2G100 Mini Kleenpak™ 20 Filter Capsules with Emflon® II Membrane 100
 
分类信息
Filtration - Classic