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Posidyne® Filter Cartridges

Pall Posidyne filter cartridges incorporate a patented covalent charge-modified Nylon 6,6 membrane which exhibits a net positively-charged Zeta potential in aqueous solutions. This positive Zeta potential provides enhanced retention of fine particles smaller than the membrane’s rating, such as endotoxins in water, in a direct flow mode without the higher pressure drop of finer filters. High-area pleated into single open-ended (SOE) AB sanitary-style cartridges, N66 Posidyne filters are available in particulate and bioreduction grades and in sterilizing-grades.

Features and Benefits

  • Inherently water wettable 
  • Resin and surfactant-free 
  • Positive Zeta potential 
  • Enhanced retention of particles smaller than filter rating
  • Removes endotoxins from water
  • High protein recovery from sera and most protein solutions 
  • Low filter extractables 
  • 100% integrity-tested 
  • Individually serialized 
  • Manufactured for use in conformance with cGMP 
  • ISO 9000 Certified Quality System 
  • Pharmaceutical P optimized grades with Certificate of Test provided
  • Validation Guide available

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*

  • 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 USP Sterile Purified Water

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

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Description

Pall Posidyne filter cartridges incorporate a patented covalent charge-modified Nylon 6,6 membrane which exhibits a net positively-charged Zeta potential in aqueous solutions. This positive Zeta potential provides enhanced retention of fine particles smaller than the membrane’s rating, such as endotoxins in water, in a direct flow mode without the higher pressure drop of finer filters. High-area pleated into single open-ended (SOE) AB sanitary-style cartridges, N66 Posidyne filters are available in particulate and bioreduction grades and in sterilizing-grades.

Features and Benefits

  • Inherently water wettable 
  • Resin and surfactant-free 
  • Positive Zeta potential 
  • Enhanced retention of particles smaller than filter rating
  • Removes endotoxins from water
  • High protein recovery from sera and most protein solutions 
  • Low filter extractables 
  • 100% integrity-tested 
  • Individually serialized 
  • Manufactured for use in conformance with cGMP 
  • ISO 9000 Certified Quality System 
  • Pharmaceutical P optimized grades with Certificate of Test provided
  • Validation Guide available

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*

  • 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 USP Sterile Purified Water

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

Specifications

Materials of Construction

Membrane  Nylon 6,6, covalently-modified positive Zeta
Supports, Drainage and End Caps  Polyester
Core and Cage  Polypropylene
 O-ring  Silicone1
1 Other polymers available.

 

Microbial Removal Ratings2

NNXZ  0.45 µm microbial-rated (Typical Serratia marcesens TR > 109)
NXZ, NLZ  0.45 µm microbial-rated
NBAZ, NAZ  0.2 µm microbial-rated (Typical Brevundimonas diminuta TR > 104– 6)
NIZ  0.1 µm microbial-rated (Typical Brevundimonas diminuta TR > 109)
NFZ  0.2 µm sterilizing-grade
NTZ  0.1 µm sterilizing-grade
2  Lot samples retain > 107 cfu/cm2 of an appropriate challenge organism per mod. ASTM F838-83 and FDA guidelines; NXZ, NLZ: Serratia marcescens; NFZ, NTZ, NDZ: Brevundimonas diminuta; NTZ 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 and Temperature 5.5 bard (80 psid) to 50 °C
4.1 bard (60 psid) to 80 °C
3 Using compatible fluids.

 

Configuration (AB Code 7)4

Double 226 O-ring adapter
Fin end with bayonet lock
4 Alternate adapter styles available.

 

Typical Liquid Flow Rate5

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

 

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 254 mm (10 in.) Element

 Typically 15 – 25 mg

 

Particle Removal Efficiencies

 Endotoxin Removal Efficiency7 > 99.997% to 0.16 gm E. coli endotoxin
 Polystyrene Bead Efficiency8 NLZ, NAZ, NIZ to > 1 gm loading: > 99.99% for 0.04 µm beads
NFZ, NTZ to > 2 – 10 gm loading: > 99.99% for 0.04 µm beads
7 Determined for 254 mm (10 in.) elements challenged in deionized water. No endotoxin detectable in effluent using LAL reagent with sensitivity of < 0.5 EU/mL.
8 Determined for 254 mm (10 in.) elements challenged in deionized water. Capacity determined at breakthrough (effluent turbidity).

 

Type

Filter Cartridges

Use

Sterilizing-Grade Liquid Filtration

Product Summary

Posidyne® Filter Cartridges are the ideal components for fine particle retention. All Pall filters are 100% integrity tested and manufactured under GMP compliance. The construction is resin free with wettable capabilities. Posidyne has Zeta potential to provide enhanced particle retention and endotoxin removal. Filters are available in bioreduction and sterilizing grades as well to best fit several biotech systems.

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