Ultipor® N66 - Kleenpak™ Capsules product photo Primary L

Ultipor® N66 Membrane in Kleenpak™ Capsules

Pall Kleenpak sterilizing-grade capsule filters with intrinsically hydrophilic Ultipor N66 membrane are self-contained sanitary filters designed for convenient small-batch sterile filtration of most biopharmaceutical solutions. Rugged, compact design ensures reliability.

Features and Benefits

  • 100% integrity and pressure tested
  • 0.2 micron NFP sterilizing-grade
  • 0.1 micron NTP sterilizing-grade for bacteria and mycoplasma removal
  • Low filter extractables
  • Excellent solvent compatibility
  • Sanitary vent and drain valves with non-twist hose barbs
  • Low hold-up volumes (< 1 mL)
  • Gamma-irradiatable, autoclavable, and pre-sterilized versions available for maximum flexibility
  • Autoclavable versions can be repeatedly autoclaved
  • Manufactured for use in conformance with cGMP
  • ISO 9000 certified Quality system
  • Pharmaceutical P optimized
  • Certificate of test provided

Quality and Bio-Safety Biological Tests

Integrity

  • Every filter 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; pH per Sterile Purified Water

Autoclave Resistance

  • Lot samples multi-cycle autoclave challenged

* Per lot sample or rinse-flush aliquots.



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설명

Pall Kleenpak sterilizing-grade capsule filters with intrinsically hydrophilic Ultipor N66 membrane are self-contained sanitary filters designed for convenient small-batch sterile filtration of most biopharmaceutical solutions. Rugged, compact design ensures reliability.

Features and Benefits

  • 100% integrity and pressure tested
  • 0.2 micron NFP sterilizing-grade
  • 0.1 micron NTP sterilizing-grade for bacteria and mycoplasma removal
  • Low filter extractables
  • Excellent solvent compatibility
  • Sanitary vent and drain valves with non-twist hose barbs
  • Low hold-up volumes (< 1 mL)
  • Gamma-irradiatable, autoclavable, and pre-sterilized versions available for maximum flexibility
  • Autoclavable versions can be repeatedly autoclaved
  • Manufactured for use in conformance with cGMP
  • ISO 9000 certified Quality system
  • Pharmaceutical P optimized
  • Certificate of test provided

Quality and Bio-Safety Biological Tests

Integrity

  • Every filter 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; pH per Sterile Purified Water

Autoclave Resistance

  • Lot samples multi-cycle autoclave challenged

* Per lot sample or rinse-flush aliquots.

규격사양

Materials of Construction

 Membrane  Nylon 6,6
 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 Ratings1

NF  0.2 µm, sterilizing-grade, Brevundimonas diminuta
NT  0.1 µm, sterilizing-grade,2Brevundimonas diminuta
1 Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per modified ASTM F838-83 and FDA guidelines.
2 Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma.

 

 

 

Nominal Filter Areas

Size Code KA1 KA2 KA3 KA4
NF 0.05 m2
(0.53 ft2
0.1 m2
(1 ft2
0.2 m2
(2.1 ft2)
0.5 m2
(5.3 ft2)
 NT 0.045 m2
(0.4 ft2)
0.08 m2
(0.8 ft2)
0.2 m2
(2.1 ft2)
0.4 m2
(4 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 and 8]) 117 mm
(4.6 in.)
158 mm
(6.2 in.)
174 mm
(6.8 in.)
286 mm
(11.2 in.)
* Sanitary connection is Tri-Clamp compatible. Tri-Clamp is a trademark of Alfa Laval, Inc

 

 

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. Recommended maximum 3.5 barg (50 psig) in continuous air and gas service. KA*NT filters may be forward flow tested at 5171 mbar (75 psig) at ambient temperature.

 

 

Typical Liquid Flow Rates4

4 Typical initial clean ∆P; water at 20 °C, 1 cP. Values shown are 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

Size Code KA1 KA2 KA3 KA4
Non irradiated 7 mg 10 mg 12 mg 20 mg
Pre-sterilized  6 mg  12 mg  22 mg  N/A

5 Water at 20 – 25 °C after autoclaving.
N/A = Filter not available

 

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. Filters should be qualified in actual use. Contact Pall for recommended procedures
Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through under pressure.

 

 

Sterilization

 Gamma-irradiation Maximum Dosage (G Grade)  50 kGy
Note: Contact Pall for specific part number availability.
S and G grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 with with inlet and outlet options 1 and 6.
Autoclavable grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 and KA4 with with inlet and outlet options 1 and 6.

 

종류

Filter Capsules

사용

Bioburden Filtration

적용분야

DO NOT MAP

영역

Filtration - Classic

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