Posidyne® - Kleenpak™ Capsules product photo Primary L

Posidyne® - Kleenpak™ Capsules

Pall Kleenpak liquid capsule filters with intrinsically hydrophilic positive zeta potential Posidyne membrane are rugged, self-contained sanitary filters designed for small-batch sterile filtration of aqueous pharmaceutical solutions. With a net positive charge in most aqueous solutions from pH 3 to 10, Kleenpak Capsules with Posidyne Membrane Assemblies can effectively remove contaminants such as cell debris and endotoxin smaller than the filter rating.

Features and Benefits

  • Positive Zeta potential for enhanced efficiency in aqueous solutions
  • Double-layer sterilizing membranes for high reliability
  • 100% integrity and pressure-tested
  • High protein recovery from serum and most protein solutions
  • 0.2 µm NF grade for sterilization
  • 0.1 µm NT grade for diminutive bacteria and mycoplasma removal
  • Low filter extractables
  • Sanitary vent and drain valves with non-twist hose barbs
  • Upstream hold-up volumes (< 1 mL)
  • Repeatedly autoclavable
  • Manufactured for use in conformance with cGMP
  • IS0 9000 Certified Quality System
  • Pharmaceutical P optimized
  • Certificate of Test provided

Quality and Bio-Safety 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; pH per Sterile Purified Water

 * Per lot sample soak or rinse-up flush aliquots.

Autoclave Resistance

  • Lot samples multi-cycle autoclave challenged


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Description

Pall Kleenpak liquid capsule filters with intrinsically hydrophilic positive zeta potential Posidyne membrane are rugged, self-contained sanitary filters designed for small-batch sterile filtration of aqueous pharmaceutical solutions. With a net positive charge in most aqueous solutions from pH 3 to 10, Kleenpak Capsules with Posidyne Membrane Assemblies can effectively remove contaminants such as cell debris and endotoxin smaller than the filter rating.

Features and Benefits

  • Positive Zeta potential for enhanced efficiency in aqueous solutions
  • Double-layer sterilizing membranes for high reliability
  • 100% integrity and pressure-tested
  • High protein recovery from serum and most protein solutions
  • 0.2 µm NF grade for sterilization
  • 0.1 µm NT grade for diminutive bacteria and mycoplasma removal
  • Low filter extractables
  • Sanitary vent and drain valves with non-twist hose barbs
  • Upstream hold-up volumes (< 1 mL)
  • Repeatedly autoclavable
  • Manufactured for use in conformance with cGMP
  • IS0 9000 Certified Quality System
  • Pharmaceutical P optimized
  • Certificate of Test provided

Quality and Bio-Safety 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; pH per Sterile Purified Water

 * Per lot sample soak or rinse-up flush aliquots.

Autoclave Resistance

  • Lot samples multi-cycle autoclave challenged

Specifications

Materials of Construction

 Membrane  Nylon 6,6, positively-charged
 Support and Drainage  Polyester
 Core and Cage  Autoclavable Version:  Polypropylene
G and S Grades:   Polyester
 End Caps and Shell  Polyester
 Vent and Drain Valve O-ring  Ethylene Propylene (EPDM)

 

 

Microbial Removal Ratings

NFZ  0.2 µm, sterilizing-grade1
NTZ  0.1 µm, sterilizing-grade2
1 Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per mod. ASTM F838-83 and FDA guidelines.
2 Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma.

 

 

Nominal Filter Areas

Size Code KA1 KA2 KA3 KA4
 Effective Filter Area 0.05 m2
(0.53 ft2
0.1 m2
(1 ft2
0.2 m2
(2.1 ft2)
0.5 m2
(5.3 ft2)

 

Nominal Dimensions

Size Code KA1 KA2 KA3 KA4
 Maximum Diameter of Bowl (including Valves)

94 mm
(3.7 in.)

94 mm
(3.7 in.) 
109 mm
(4.2 in.)
109 mm
(4.2 in.)
 Length (including Sanitary Connection [Code 1]) 117 mm
(4.6 in.)
158 mm
(6.2 in.)
174 mm
(6.8 in.)
286 mm
(11.2 in.)
 Length (including Stepped Hose Barb Connection [Code 2]) 158 mm
(6.2 in.)
199 mm
(7.8 in.)
 Length (including Hose Barb Connection [Code 6])  -  - 210 mm
(8.2 in.)
325 mm
(12.7 in.)

 

 

Operating Conditions3

Maximum Pressure and Temperature     5.2 barg (75 psig) to 40 °C
 Maximum Differential Pressure     4.1 bard (60 psid) at 40 °C
3 Using compatible liquids. Maximum 3.5 barg (50 psig) in air/gas service.

 

Typical Liquid Flow Rates4

4 Typical initial clean ∆P, water at 20 °C, 1 cP. KA4NFZP ∆P flow is 37 mbard/L per min (2.1 psid/gpm). Pressure drops at other flows are directly proportional to flow. Values shown for 38 mm (1½ in.) sanitary flange connections. Values with other connections are available on request. For assistance, contact your local Pall representative.

 

 

Aqueous Extractables (NVR)5 (Non G and S Grades)

KA1 KA2 KA3 KA4
 6 mg  12 mg  20 mg  40 mg
5 Water at 20 – 25 °C after autoclaving.

 

Steam Autoclaving6 (Non G and S Grades)

 Cumulative Autoclave Time 16 hours at 125 °C
4 hours at 140 °C
6 Laboratory tests (1-hour cycles) establish multi-cycle.
Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through under pressure.

 

 

Sterilization

 Gamma-irradiation Maximum Dosage (G Grade)  35 kGy

Type

Filter Capsules

Use

Sterilizing-Grade Liquid Filtration

Product Summary

Kleenpak™ Capsules with Posidyne® Membrane meet cleanliness requirement per USP Particulates in Injectable. It features positive Zeta potential for enhanced efficiency in aqueous solutions. Capsules contain a double-layer sterilizing membrane for high reliability and high-quality product. Filters are self-contained and designed for small sterile filtration systems throughout a range of acidic to basic solutions.

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