Bioinert® Sterilizing-grade Filter Cartridges product photo Primary L

Bioinert® Sterilizing-grade Filter Cartridges

Pall filters with Bio-Inert grade membrane are 0.2 micron rated filters, validated  to produce sterile effluent when challenged with B. diminuta (ATCC 19146) at a concentration greater than 107cfu per cm² effective filter area of membrane (per ASTM 838-05). Incorporating two layers of modified N66 filter membrane, they exhibit broad liquid compatibility and are well-suited to the microbial filtration of process fluids where the end-user desires to minimize non-specific adsorption of active ingredients.

Pall's standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L). With Code 7 fittings as standard, these cartridges are the most versatile filtration units in Pall's product range, and are available with a broader range of filtration media than any other filter type. These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.

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
  • Low protein-binding for excellent product transmission
  • Repeatedly steamable in situ

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.



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Description
Pall filters with Bio-Inert grade membrane are 0.2 micron rated filters, validated  to produce sterile effluent when challenged with B. diminuta (ATCC 19146) at a concentration greater than 107cfu per cm² effective filter area of membrane (per ASTM 838-05). Incorporating two layers of modified N66 filter membrane, they exhibit broad liquid compatibility and are well-suited to the microbial filtration of process fluids where the end-user desires to minimize non-specific adsorption of active ingredients.

Pall's standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L). With Code 7 fittings as standard, these cartridges are the most versatile filtration units in Pall's product range, and are available with a broader range of filtration media than any other filter type. These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.

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
  • Low protein-binding for excellent product transmission
  • Repeatedly steamable in situ

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

 
NRL, NFL  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 F838-05 and FDA guidelines; NRL, NFL, Brevundimonas diminuta

Nominal Dimensions

 
Lengths   254 mm (10 in.), 508 mm (20 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
 
³In 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

 
Ordering Information
 
Part Number1 Description
AB1NFL7PH4 Bio-Inert Membrane Filter Cartridge, Grade NFL

Nominal length 254 mm (10 in.); Pall Code 7 double O-ring, bayonet lock and fin
AB2NFL7PH4 Bio-Inert Membrane Filter Cartridge, Grade NFL

Nominal length 508 mm (20 in.); Pall Code 7 double O-ring, bayonet lock and fin
AB1NRL7PH4 Bio-Inert Membrane Filter Cartridge, Grade NRL

Nominal length 254 mm (10 in.); Pall Code 7 double O-ring, bayonet lock and fin
AB2NRL7PH4 Bio-Inert Membrane Filter Cartridge, Grade NRL

Nominal length 508 mm (20 in.); Pall Code 7 double O-ring, bayonet lock and fin
AB1NT7PH4 Bio-Inert Membrane Filter Cartridge, Grade NT

Nominal length 254 mm (10 in.); Pall Code 7 double O-ring, bayonet lock and fin
AB2NT7PH4 Bio-Inert Membrane Filter Cartridge, Grade NT

Nominal length 508 mm (20 in.); Pall Code 7 double O-ring, bayonet lock and fin
 
1 All configurations shown are pharmaceutical-grade filters designed for use in conformance with CGMP in manufacturing, processing, packing or holding of drugs (21 CFR 210) and CGMP for finished pharmaceuticals (21 CFR 211.72) including batch release certificate and full traceability. For non-pharmaceutical grade filters, omit the letter P from the part number, e.g. AB1NFL7H4
Application
Filters - Liquid - Sterile (0.2 micron)
Segment
Filtration