pall,颇尔,配Posidyne膜的Kleenpak囊式过滤器,

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配Posidyne膜的Kleenpak囊式过滤器
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pall,颇尔,配Posidyne膜的Kleenpak囊式过滤器,
pall,颇尔,配Posidyne膜的Kleenpak囊式过滤器

配Posidyne®膜的<FONT size=3><FONT color=#000000>Kleenpak™<a href='http://pall.net.cn/' target='_blank'>囊式过滤器</a></FONT></FONT>
颇尔 Kleenpak capsule filters with intrinsically hydrophilic positive zeta potential Posidyne membrane are rugged, self-contained sanitary filters designed for small-batch sterile filtration of aqueous pharmaceutical solutions.With a net positive charge in most aqueous solutions from pH 3 to 10, Kleenpak Capsules with Posidyne Membrane Assemblies can be effective in removing contaminants such as cell debris and endotoxin smaller than the filter rating.

特色及优点

  • Positive Zeta potential for enhanced efficiency in aqueous solutions
  • Double-layer sterilizing membranes for high reliability
  • 100% integrity and pressure-tested
  • High protein recovery from serum and most protein solutions
  • 0.2 µm NF grade for sterilization
  • 0.1 µm NT grade for diminutive bacteria and mycoplasma removal
  • Low filter extractables
  • Sanitary vent and drain valves with non-twist hose barbs
  • Upstream hold-up volumes (< 1 mL)
  • Repeatedly autoclavable
  • Manufactured for use in conformance with cGMP
  • IS0 9000 Certified Quality System
  • Pharmaceutical P optimized
  • Certificate of Test provided

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 Sterile Purified Water

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

Autoclave Resistance

  • Lot samples multi-cycle autoclave challenged
 
 

材料成分

 

 
   Nylon 6,6, positively-charged
 Support and Drainage  聚酯
 Core and Cage  Autoclavable Version: 聚丙烯
G and S Grades:  聚酯
 End Caps and Shell  聚酯
 Vent and Drain Valve O-ring  Ethylene Propylene (EPDM)
 

 

 

Microbial Removal Ratings

 
NFZ  0.2 µm, sterilizing-grade1
NTZ  0.1 µm, sterilizing-grade2
 
1 Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per mod.ASTM F838-83 and FDA guidelines.
2 Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma.

 

 

Nominal Filter Areas

 

 
Size Code KA1 KA2 KA3 KA4
 Effective Filter Area 0.05 m2
(0.53 ft2
0.1 m2
(1 ft2
0.2 m2
(2.1 ft2)
0.5 m2
(5.3 ft2)
 

 

Nominal Dimensions

 

 
Size Code KA1 KA2 KA3 KA4
 Maximum Diameter of Bowl (including Valves)

94 mm
(3.7 in.)

94 mm
(3.7 in.) 
109 mm
(4.2 in.)
109 mm
(4.2 in.)
 Length (including Sanitary Connection [Code 1]) 117 mm
(4.6 in.)
158 mm
(6.2 in.)
174 mm
(6.8 in.)
286 mm
(11.2 in.)
 Length (including Stepped Hose Barb Connection [Code 2]) 158 mm
(6.2 in.)
199 mm
(7.8 in.)
 Length (including Hose Barb Connection [Code 6])  -  - 210 mm
(8.2 in.)
325 mm
(12.7 in.)
 

 

 

Operating Conditions3

 
Maximum Pressure and Temperature     5.2 barg (75 psig) to 40 °C
 Maximum Differential Pressure     4.1 bard (60 psid) at 40 °C
 
3 Using compatible liquids.Maximum 3.5 barg (50 psig) in air/gas service.

 

Typical Liquid Flow Rates4

4 Typical initial clean ∆P, water at 20 °C, 1 cP.KA4NFZP ∆P flow is 37 mbard/L per min (2.1 psid/gpm).Pressure drops at other flows are directly proportional to flow.Values shown for 38 mm (1½ in.) sanitary flange connections.Values with other connections are available on request.For assistance, contact 上海羽令.

 

 

Aqueous Extractables (NVR)5 (Non G and S Grades)

 
KA1 KA2 KA3 KA4
 6 mg  12 mg  20 mg  40 mg
 
5 Water at 20 – 25 °C after autoclaving.

 

Steam Autoclaving6 (Non G and S Grades)

 
 Cumulative Autoclave Time 16 hours at 125 °C
4 hours at 140 °C
 
6 Laboratory tests (1-hour cycles) establish multi-cycle.
Warning:Kleenpak filters must not be steam-sterilized in situ by passing steam through under pressure.

 

 

Sterilization

 

 
 Gamma-irradiation Maximum Dosage (G Grade)  35 kGy
 

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