Posidyne® Filter Cartridges
Point of Product
Description
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
Specification
Materials of Construction
Membrane
| Nylon 6,6, covalently-modified positive Zeta
|
Supports, Drainage and End Caps
| Polyester
|
Core and Cage
| Polypropylene
|
O-ring
| Silicone1
|
1Other polymers available.
Microbial Removal Ratings
2
NNXZ
| 0.45 µm microbial-rated (Typical Serratia marcesens TR > 10 9 )
|
NXZ, NLZ
| 0.45 µm microbial-rated
|
NBAZ, NAZ
| 0.2 µm microbial-rated (Typical Brevundimonas diminuta TR > 10 4-6 )
|
NIZ
| 0.1 µm microbial-rated (Typical Brevundimonas diminuta TR > 10 9 )
|
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 Condition 3
Maximum Differential Pressure and Temperature
| 5.5 bard (80 psid) to 50 °C
|
3 Using compatible fluids.
Configuration (AB Code 7)
4
Double 226 O-ring adapter
|
4 Alternate adapter styles available.
Typical Liquid Flow Rate 5
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 Situ
6
Cumulative Steam Exposure
| 16 hours (1-hour cycles) at 121 °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
|
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.