Emflon® ll Membrane in Kleenpak™ Capsules product photo Primary L

Emflon® ll Membrane in Kleenpak™ Capsules

Gamma Compatible, Sterilizing Grade Air Filtration

For single-use installations, from upstream to final formulation and fill, Emflon II membrane is the go-to gas filter for safeguarding cell cultures and drug product from adventitious bacterial and viral contamination.

Mini Kleenpak capsules with Emflon II membrane delivers scalable, gamma-compatible, sterilizing grade air filtration for use on process gas and vent applications. With a comprehensive validation and quality package, Mini Kleenpak capsules with Emflon II membrane are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

Features and Benefits

  • Highly-retentive Emflon II membrane for sterility assurance
  • High flow-rates associated with low differential pressure enable the use of small filters – reduction of installation and operating costs
  • Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience
  • Integrity testable using the forward flow and bubble point test
  • Choice of connection options for enhanced flexibility

Biological Tests

  • Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C

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 and unique serial number for complete traceability of manufacturing history and for user traceability systems
  • Comprehensive batch/release testing supported with a pharmaceutical certificate of test for each filter
  • Validation guide available
  • Manufactured under a quality management system certified to ISO 9001:2015

 



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Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, ½ in. hose barb connections, pre-sterilized by gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, ½ in. hose barb connections, pre-sterilized by gamma irradiation

Product ID: KA3V002PV6S
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
1700 cm²
See All Attributes

This product is currently not available. Please contact us for more information.

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 820 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 820 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation

Product ID: KA2V002PV2S
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
820 cm²
See All Attributes

This product is currently not available. Please contact us for more information.

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, 1-1½ in. sanitary flange connections, suitable for gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, 1-1½ in. sanitary flange connections, suitable for gamma irradiation

Product ID: KA3V002PV1G
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
1700 cm²
See All Attributes
Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 380 cm² EFA, 1-1½ in. sanitary flange connections, pre-sterilized by gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 380 cm² EFA, 1-1½ in. sanitary flange connections, pre-sterilized by gamma irradiation

Product ID: KA1V002PV1S
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
380 cm²
See All Attributes
Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, ½ in. hose barb connections, suitable for gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, ½ in. hose barb connections, suitable for gamma irradiation

Product ID: KA3V002PV6G
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
1700 cm²
See All Attributes
Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, 1-1½ in. sanitary flange connections, pre-sterilized by gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 1700 cm² EFA, 1-1½ in. sanitary flange connections, pre-sterilized by gamma irradiation

Product ID: KA3V002PV1S
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
1700 cm²
See All Attributes
Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 380 cm² EFA, 1-1½ in. sanitary flange connections, suitable for gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 380 cm² EFA, 1-1½ in. sanitary flange connections, suitable for gamma irradiation

Product ID: KA1V002PV1G
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
380 cm²
See All Attributes
Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 820 cm² EFA, ¼-½ in. hose barb connections, suitable for gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 820 cm² EFA, ¼-½ in. hose barb connections, suitable for gamma irradiation

Product ID: KA2V002PV2G
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
820 cm²
See All Attributes
Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 820 cm² EFA, 1-1½ in. sanitary flange connections, suitable for gamma irradiation product photo

Emflon® II membrane in Kleenpak™ capsule, 0.2 µm sterilizing grade, 820 cm² EFA, 1-1½ in. sanitary flange connections, suitable for gamma irradiation

Product ID: KA2V002PV1G
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
820 cm²
See All Attributes

Documents

Datasheets

Download: English

Description

Gamma Compatible, Sterilizing Grade Air Filtration

For single-use installations, from upstream to final formulation and fill, Emflon II membrane is the go-to gas filter for safeguarding cell cultures and drug product from adventitious bacterial and viral contamination.

Mini Kleenpak capsules with Emflon II membrane delivers scalable, gamma-compatible, sterilizing grade air filtration for use on process gas and vent applications. With a comprehensive validation and quality package, Mini Kleenpak capsules with Emflon II membrane are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

Features and Benefits

  • Highly-retentive Emflon II membrane for sterility assurance
  • High flow-rates associated with low differential pressure enable the use of small filters – reduction of installation and operating costs
  • Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience
  • Integrity testable using the forward flow and bubble point test
  • Choice of connection options for enhanced flexibility

Biological Tests

  • Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C

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 and unique serial number for complete traceability of manufacturing history and for user traceability systems
  • Comprehensive batch/release testing supported with a pharmaceutical certificate of test for each filter
  • Validation guide available
  • Manufactured under a quality management system certified to ISO 9001:2015

 

Specifications

Nominal Dimensions

 
KA1 Capsule KA2 Capsule KA3 Capsule
Maximum Diameter (Including Valves) 90.5 mm (3.6 in.) 90.5 mm (3.6 in.) 105.5 mm (4.2 in.)
Length with Hose Barb Connections 158 mm (6.2 in.) 198 mm (7.8 in.) 210 mm (8.3 in.)
Length with Sanitary Connections 117 mm (4.6 in.) 157 mm (6.2 in.) 174 mm (6.8 in.)
Nominal Filtration Area  380 cm2 (0.41 ft2) 820 cm2 (0.88 ft2) 1700 cm2 (1.83 ft2)
 

Materials of Construction

  • Membrane hydrophobic: Hydrophobic PVDF
  • Support and drainage layers: Polypropylene
  • End cap and core: Polypropylene
  • Outer shell: Polypropylene
  • Vent and drain valve O-rings: Ethylene propylene (EPDM)

Operating Conditions1

  • Maximum temperature: 40 °C
  • Maximum operating pressure: 3.5 bar (50 psi) at 40 °C

1 In air/nitrogen gas service or other compatible fluids, which do not soften, swell, or adversely affect the filter or its materials of construction.

Sterilization

  • Gamma irradiation maximum dosage (G option only): Up to 50 kGy
  • Autoclave sterilization:
    • Gamma-irradiated filters: 1 one-hour cycle at 125 ºC for the purpose of post-use decontamination
    • Non gamma-irradiated filters: Up to 3 one-hour cycles at 125 ºC

Warning: Kleenpak filters must not be in situ steam-sterilized by passing steam through under pressure. The figures are maximum allowable figures determined by testing under controlled laboratory conditions to the total number of hours indicated. Actual operating conditions may affect the filters long-term response to sterilization. Filters should be qualified for each process application.

Typical Air Flow Rates2,3

Figure 1
Sanitary flange connections: vent conditions


Figure 2
Hosetail connections: vent conditions


Figure 3
Sanitary flange connections: 2 bar operating pressure


Figure 4
Hosetail connections: 2 bar operating pressure

2 For gases other than air or nitrogen, contact your local Pall representative.
3 Recommended flow limits have been based on a maximum velocity of 20 m/s through the capsule. Customer tubing sizes should also be considered.

Type

Filter Capsules

Use

Air, Gas, and Vent Filtration

Ordering Information

 
Description Part Number
KA1V002PV1S Kleenpak capsule with Emflon II membrane, with 1½ in. sanitary flange, gamma-irradiated
KA1V002PV1G Kleenpak capsule with Emflon II membrane, with 1½ in. sanitary flange, non irradiated
KA1V002PV2S Kleenpak capsule with Emflon II membrane, with ¼ – ½ in. hose barb, gamma-irradiated
KA1V002PV2G Kleenpak capsule with Emflon II membrane, with ¼ – ½ in. hose barb, non irradiated
KA2V002PV1S Kleenpak capsule with Emflon II membrane, with 1½ in. sanitary flange, gamma-irradiated
KA2V002PV1G Kleenpak capsule with Emflon II membrane, with 1½ in. sanitary flange, non irradiated
KA2V002PV2S Kleenpak capsule with Emflon II membrane, with ¼ – ½ in. hose barb, gamma-irradiated
KA2V002PV2G Kleenpak capsule with Emflon II membrane, with ¼ – ½ in. hose barb, non irradiated
KA2V002PV6S Kleenpak capsule with Emflon II membrane, with ½ in. hose barb, gamma-irradiated
KA2V002PV6G Kleenpak capsule with Emflon II membrane, with ½ in. hose barb, non irradiated
KA3V002PV1S Kleenpak capsule with Emflon II membrane, with 1½ in. sanitary flange, gamma-irradiated
KA3V002PV1G Kleenpak capsule with Emflon II membrane, with 1½ in. sanitary flange, non irradiated
KA3V002PV6S Kleenpak capsule with Emflon II membrane, with 1½ in. hose barb, gamma-irradiated
KA3V002PV6G Kleenpak capsule with Emflon II membrane, with 1½ in. hose barb, non irradiated
 

Product Summary

Emflon® II Membrane in Kleenpak™ Capsules serves the user's specific systematic needs. Pall offers options including gama-irradiatable, pre-sterilized and custom-made sets. All versions perform to the same top quality standard. Each unit is fully integrity testable and has the highly retentive Emflon II membrane. These capsule filters provide high air flows of both air and gas.

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