Ultipor® N66 Particulate and Bioreduction Filter Cartridges product photo Primary L

Ultipor® N66 Particulate and Bioreduction Filter Cartridges

Pall Ultipor® N66 particulate/bioreduction filter cartridges are specifically engineered for fine filtration, prefiltration and bioburden reduction of a wide range of pharmaceutical and biological liquids. They incorporate versatile Ultipor N66 pure Nylon 6,6 membranes which are high-area pleated into single open-ended (SOE) AB style cartridges to fit in sanitary filter housings, and provide reliable, economical and efficient particulate and bioburden removal.

Features and Benefits

  • Intrinsically water wettable 
  • Fixed pores, non-shedding 
  • Resin and surfactant-free
  • Low filter extractables 
  • High-area for long-life
  • Broad solvent compatibility 
  • High protein recovery from most protein solutions 
  • Repeatedly steamable in situ 
  • Manufactured for use in conformance with cGMP
  • ISO 9000 Certified Quality System 
  • Pharmaceutical P optimized 
  • Certificate of Test provided 
  • Double open-ended (DOE) available 
  • FDA-listed materials per 21 CFR
    Note: These filters are also available in Kleenpak Nova capsule format.

Quality and Bio-Safety


Biological Tests

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

Effluent Quality Tests (AB Style)*

  • Meets Cleanliness per USP Particulates in Injectables 
  • Non-Fiber-Releasing 
  • Non-Pyrogenic per USP 
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
    * Per lot sample soak or rinse-up flush aliquots.


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Description
Pall Ultipor® N66 particulate/bioreduction filter cartridges are specifically engineered for fine filtration, prefiltration and bioburden reduction of a wide range of pharmaceutical and biological liquids. They incorporate versatile Ultipor N66 pure Nylon 6,6 membranes which are high-area pleated into single open-ended (SOE) AB style cartridges to fit in sanitary filter housings, and provide reliable, economical and efficient particulate and bioburden removal.

Features and Benefits

  • Intrinsically water wettable 
  • Fixed pores, non-shedding 
  • Resin and surfactant-free
  • Low filter extractables 
  • High-area for long-life
  • Broad solvent compatibility 
  • High protein recovery from most protein solutions 
  • Repeatedly steamable in situ 
  • Manufactured for use in conformance with cGMP
  • ISO 9000 Certified Quality System 
  • Pharmaceutical P optimized 
  • Certificate of Test provided 
  • Double open-ended (DOE) available 
  • FDA-listed materials per 21 CFR
    Note: These filters are also available in Kleenpak Nova capsule format.

Quality and Bio-Safety


Biological Tests

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

Effluent Quality Tests (AB Style)*

  • Meets Cleanliness per USP Particulates in Injectables 
  • Non-Fiber-Releasing 
  • Non-Pyrogenic per USP 
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
    * Per lot sample soak or rinse-up flush aliquots.
Specifications

Materials of Constructions

 Membrane  Nylon 6,6
 Support, Drainage and End Caps  Polyester
 Core and Cage  Polypropylene
  O-rings  Silicone1
1 Other materials available on request

 

Microbial Removal Ratings

 NK  0.65 µm particulate rated
 NB  0.45 µm microbial-rated (Typical Serratia marcescens TR > 104 – 6)
 NX, NL  0.45 µm microbial-rated (Lot samples retain > 107/cm2 Serratia marcescens)
 NA  0.2 µm microbial-rated (Typical Brevundimonas diminuta TR > 104 – 6)

Nominal Dimensions

 Lengths  254 mm (10 in.), 508 mm (20 in.), 762 mm (30 in.), 1016 mm (40 in.)
 Diameter  70 mm (2.75 in.)

Configuration (AB Code 7)2

Double 226 O-ring adapter
Fin end with bayonet lock
2 Alternate adapters codes available on request

 

Operating Conditions3

Maximum Differential Pressure and Temperature  5 .5 bard (80 psid) to 50 °C
4.1 bard (60 psid) to 80 °C
2.1 bard (30 psid) to 125 °C
3 Using compatible liquids

 

Typical Flow Rates 4

4 Typical initial clean media P 254mm (10 in.) element; water at 20 °C; viscosity 1 cP. For assistance in filter assembly sizing and housing selection, contact your local Pall representative.

 

Autoclave and Steaming in situ5

Cumulative Steam Exposure  16 hours (1-hour cycles) at 121 °C
4 hours (1-hour cycles) at 140 °C
5 Contact Pall for details

 

Aqueous Extractables (NVR) per 254 mm (10 in.) Element

 Typically < 15 – 20 mg
 

 

Application
DO NOT MAP
Segment
Filtration