Ultipor® N66 Sterilizing-Grade Filter Cartridges product photo Primary L

Ultipor® N66 Sterilizing-Grade Filter Cartridges

Pall Ultipor® N66 sterilizing-grade filter cartridges feature high-strength pure Nylon 6,6 membranes for higher sterility assurance. In wide use for almost 20 years, these filters have a proven record of performance in the production of sterile biologicals and pharmaceuticals. High-area pleated into single open-ended (SOE) AB sanitary style cartridges, Ultipor N66 sterilizing-grade filter cartridges are available with ratings from 0.45 µm for LVPs, reagents and viscous fluids, 0.2 µm for sterile products and intermediates, 0.1 µm for sterilization and mycoplasma removal from biologicals, to 0.04 µm for sterilization and virus reduction from biologicals.

Features and Benefits

  • Intrinsically water wettable
  • Fixed pores, non-shedding
  • Resin and surfactant-free
  • Broad solvent compatibility
  • Low filter extractables
  • High-area for long-life
  •  High protein recovery from most protein solutions
  • Repeatedly steamable in situ

Note: These filters are also available in Kleenpak Nova capsule format.

Quality and Bio-Safety*

Integrity

  • Every filter integrity tested during manufacture. Test correlated to microbial retention

Biological Tests

  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing per 21 CFR
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water

Steam Resistance

  • Lot samples multi-cycle autoclave challenged

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



* Required
Description
Pall Ultipor® N66 sterilizing-grade filter cartridges feature high-strength pure Nylon 6,6 membranes for higher sterility assurance. In wide use for almost 20 years, these filters have a proven record of performance in the production of sterile biologicals and pharmaceuticals. High-area pleated into single open-ended (SOE) AB sanitary style cartridges, Ultipor N66 sterilizing-grade filter cartridges are available with ratings from 0.45 µm for LVPs, reagents and viscous fluids, 0.2 µm for sterile products and intermediates, 0.1 µm for sterilization and mycoplasma removal from biologicals, to 0.04 µm for sterilization and virus reduction from biologicals.

Features and Benefits

  • Intrinsically water wettable
  • Fixed pores, non-shedding
  • Resin and surfactant-free
  • Broad solvent compatibility
  • Low filter extractables
  • High-area for long-life
  •  High protein recovery from most protein solutions
  • Repeatedly steamable in situ

Note: These filters are also available in Kleenpak Nova capsule format.

Quality and Bio-Safety*

Integrity

  • Every filter integrity tested during manufacture. Test correlated to microbial retention

Biological Tests

  • Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
  • Meets Cleanliness per USP Particulates in Injectables
  • Non-Fiber-Releasing per 21 CFR
  • Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
  • Meets Total Organic Carbon and Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water

Steam Resistance

  • Lot samples multi-cycle autoclave challenged

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

Specifications

Materials of Construction

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

 

Microbial Removal Ratings2

 
NR, NF  0.2 µm sterilizing-grade
NT  0.1 µm mycoplasma sterilizing-grade
 
2 Lot samples retain > 107 cfu/cm2 of an appropriate challenge organism per mod. ASTM F838-83 and FDA guidelines; NR, NF, NT: Brevundimonas diminuta; NT also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma

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.)
 

 

Operating Conditions3

 
Maximum Differential Pressure during Steam-Sterilization 300 mbar (4.35 psi) in a forward direction
Maximum Differential Pressure and Temperature  5.5 bard (80 psid) to 50 °C
4.1 bard (60 psid) to 80 °C
 
3 In compatible fluids

 

Typical Liquid Flow Rates4

 

Configuration (AB Code 7)5

 
Double 226 O-ring adapter
Fin end with bayonet lock
 
5 Alternate adapter codes available

 

Autoclavable or Steamable In-situ6

 
 Cumulative Steam Exposure 16 hours (1-hour cycles) at 121 °C
4 hours (1-hour cycles) at 140 °C
 
6 Laboratory tests to establish multi-cycle resistance. Filters should be qualified in actual use. Contact Pall for recommended procedures.

 

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

 

 Typically 15 – 25 mg

 
Application
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Product Summary
Specifically engineered for fine filtration, prefiltration and bioburden reduction of a wide range of pharmaceutical and biological liquids, providing reliable, economical and efficient particulate and bioburden removal