pall,颇尔,Posidyne 过滤器,

pall,颇尔,Posidyne 过滤器

颇尔 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.

特色及优点

Inherently water wettable
不含树脂和表面活性剂
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

注意事项：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.

材料成分


膜	Nylon 6,6, covalently-modified positive Zeta
Supports, Drainage and End Caps	聚酯
Core and Cage	聚丙烯
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
NDZ	0.04 µm rated, sterilizing-grade (Typical MuLV, HIV (retrovirus) TR 10⁵)

²Lot 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

⁴Alternate 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 上海羽令.

Autoclavable or Steamable In Situ⁶


Cumulative Steam Exposure	16 hours (1-hour cycles) at 121 °C 4 hours (1-hour cycles) at 140 °C

⁶Laboratory tests to establish multi-cycle resistance.Filters should be qualified in actual use.Contact 颇尔 for recommended procedures.

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

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

⁷Determined 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.
⁸Determined for 254 mm (10 in.) elements challenged in deionized water.Capacity determined at breakthrough (effluent turbidity).