Bio-Inert® Grade NFL Membrane in Kleenpak™ Capsules product photo Primary L

Bio-Inert® Grade NFL Membrane in Kleenpak™ Capsules

Kleenpak filter capsules with low-protein-binding 0.2 micron Bio-Inert membrane are self-contained sanitary filters, designed for convenient sterilizing filtration of small-batch dilute protein solutions. They are validated to produce sterile effluent when challenged with B. diminuta (ATCC 19146) at a concentration greater than 107 CFU per cm2effective filter area of membrane (per ASTM 838-05). Incorporating two layers of intrinsically hydrophilic acrylate-modified Nylon 6,6 filter membrane, they are well suited to the microbial filtration of biological process fluids where the end user desires to minimize non-specific adsorption of proteins. Their rugged, compact design ensures reliability.

Features and Benefits

  • Filter elements are 100% integrity and capsules are 100% pressure tested
  • 0.2 micron sterilizing-grade
  • Low protein binding
  • Low filter extractables
  • Sanitary vent and drain valves with non-twist hose barbs
  • Low hold-up volumes
  • Autoclavable version
  • Manufactured for use in conformance with cGMP

Quality and Bio-Safety Biological Tests

Integrity Tests

Every filter element tested during manufacture. Test correlated to microbial retention

Biological Tests

Meets USP Biological Reactivity test, in vivo, for Class VI-121°C Plastics

Effluent Quality Tests*

  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing
  • Non-Pyrogenic per USP Bacterial Endotoxins (<0.25 EU/mL)
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water
* Per lot sample or rinse-flush aliquots


* Required
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Description
Kleenpak filter capsules with low-protein-binding 0.2 micron Bio-Inert membrane are self-contained sanitary filters, designed for convenient sterilizing filtration of small-batch dilute protein solutions. They are validated to produce sterile effluent when challenged with B. diminuta (ATCC 19146) at a concentration greater than 107 CFU per cm2effective filter area of membrane (per ASTM 838-05). Incorporating two layers of intrinsically hydrophilic acrylate-modified Nylon 6,6 filter membrane, they are well suited to the microbial filtration of biological process fluids where the end user desires to minimize non-specific adsorption of proteins. Their rugged, compact design ensures reliability.

Features and Benefits

  • Filter elements are 100% integrity and capsules are 100% pressure tested
  • 0.2 micron sterilizing-grade
  • Low protein binding
  • Low filter extractables
  • Sanitary vent and drain valves with non-twist hose barbs
  • Low hold-up volumes
  • Autoclavable version
  • Manufactured for use in conformance with cGMP

Quality and Bio-Safety Biological Tests

Integrity Tests

Every filter element tested during manufacture. Test correlated to microbial retention

Biological Tests

Meets USP Biological Reactivity test, in vivo, for Class VI-121°C Plastics

Effluent Quality Tests*

  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing
  • Non-Pyrogenic per USP Bacterial Endotoxins (<0.25 EU/mL)
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water
* Per lot sample or rinse-flush aliquots
Specifications

Materials of Construction

 
Membrane Nylon 6,6 Bio-Inert
Support and Drainage Polyester
Core and Cage Polypropylene or polyester
Endcaps and Shell Polyester
O-rings Ethylene Propylene (EPDM)
 

Microbial Removal Rating1

 
Grade NFL 0.2 micron, sterilizing-grade
 
1 Lot samples retain > 107 CFU/cm2 of Brevundimonas diminuta per modified ASTM F838-05 test


Typical Liquid Flow Rate2

 
Size 1 (KA1) 0.3 L/min
Size 2 (KA2) 0.6 L/min
Size 3 (KA3) 1.4L/min
 
2 Typical clean filter delta P, water at 20 °C (68 °F), 1 cP. Values shown are for 112in. (38 mm) sanitary flange connections. Values with other connections are available on request. For assistance, contact your local Pall representative


Effective Filtration Area

 
Size 1 (KA1) 0.05 m2 (0.53 ft2)
Size 2 (KA2) 0.1 m2 (1 ft2)
Size 3 (KA3) 0.23 m2 (2.1 ft2)
 

Sterilization Conditions

 
Autoclave     16 x 1-hour cycles at 125 °C (257 °F)
4 x 1-hour cycles at 140 °C (284 °F)
 

Operating Conditions3

 
Maximum Pressure and Temperature 5.2 barg (75 psig) to 40 °C (104 °F)
Maximum Differential Pressure 4.1 bard (60 psid) at 40 °C (104 °F)
 
3 Using compatible liquids


Aqueous Extractables (NVR)4

 
Size 1 (KA1) Size 2 (KA2) Size 3 (KA3)
7 mg 10 mg 12 mg
 
4 4 hours recirculation with water at 20 – 25 °C after autoclaving


Nominal Dimensions5

 
Length (including Sanitary Connection) Size 1 (KA1): 107 mm (4.6 in.)
Size 2 (KA2): 158 mm (6.2 in.)
Size 3 (KA3): 174 mm (6.8 in.)
Maximum Diameter of Bowl (including Valves) Size 1 (KA1): 94 mm (3.7 in.)
Size 2 (KA2): 94 mm (3.7 in.)
Size 3 (KA3): 109 mm (4.2 in.)
 
5 Sanitary connection is Tri-Clamp♦ compatible. Tri-Clamp is a trademark of Ladish.
Ordering Information
 
Description Part Number
Kleenpak Capsules with Bio-Inert Membrane

Size 1; 1 to 112 in. sanitary flange inlet/outlet connections
KA1NFLP1

Kleenpak Capsules with Bio-Inert Membrane

Size 1; 12 in. (13 mm) hosebarb inlet/outlet connections
KA1NFLP6

Kleenpak Capsules with Bio-Inert Membrane

Size 2; 1 to 112 in. sanitary flange inlet/outlet connections
KA2NFLP1

Kleenpak Capsules with Bio-Inert Membrane

Size 2; 14 to 12 in. (6 mm to 13 mm) stepped hose barb inlet/outlet connections
KA2NFLP2

Kleenpak Capsules with Bio-Inert Membrane

Size 2; 12 in. (13 mm) hosebarb inlet/outlet connections
KA2NFLP6

Kleenpak Capsules with Bio-Inert Membrane

Size 3; 1 to 112 in. sanitary flange inlet/outlet connections
KA3NFLP1

Kleenpak Capsules with Bio-Inert Membrane

Size 3; 12 in. (13 mm) hosebarb inlet/outlet connections
KA3NFLP6
 
Application
Filters - Liquid - Sterile (0.2 micron)
Segment
Filtration