pall,颇尔,配UltiporN66 膜的Kleenpak囊式过滤器,

产品名称:
配UltiporN66 膜的Kleenpak囊式过滤器
产品型号:
产品描述:

产品介绍

pall,颇尔,配UltiporN66 膜的Kleenpak囊式过滤器,
pall,颇尔,配UltiporN66 膜的Kleenpak囊式过滤器

配UltiporN66 膜的Kleenpak囊式过滤器
颇尔 Kleenpak sterilizing-grade capsule filters with intrinsically hydrophilic Ultipor N66 membrane are self-contained sanitary filters designed for convenient small-batch sterile filtration of most biopharmaceutical solutions.Rugged, compact design ensures reliability.

特色及优点

  • 100% integrity and pressure tested
  • 0.2 micron NFP sterilizing-grade
  • 0.1 micron NTP sterilizing-grade for bacteria and mycoplasma removal
  • Low filter extractables
  • Excellent solvent compatibility
  • Sanitary vent and drain valves with non-twist hose barbs
  • Low hold-up volumes (< 1 mL)
  • Gamma-irradiatable, autoclavable, and pre-sterilized versions available for maximum flexibility
  • Autoclavable versions can be repeatedly autoclaved
  • Manufactured for use in conformance with cGMP
  • ISO 9000 certified Quality system
  • Pharmaceutical P optimized
  • Certificate of test provided

Quality and Bio-Safety Biological Tests

Integrity
(正直诚信)

  • Every filter tested during manufacture.Test correlated to microbial retention

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

Autoclave Resistance

  • Lot samples multi-cycle autoclave challenged

* Per lot sample or rinse-flush aliquots.

 
 

材料成分

 

 
   尼龙 6,6
 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 Ratings1

 
NF  0.2 µm, sterilizing-grade, Brevundimonas diminuta
NT  0.1 µm, sterilizing-grade,2Brevundimonas diminuta
 
1 Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per modified ASTM F838-83 and FDA guidelines.
2 Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma.

 

 

 

Nominal Filter Areas

 

 
Size Code KA1 KA2 KA3 KA4
NF 0.05 m2
(0.53 ft2
0.1 m2
(1 ft2
0.2 m2
(2.1 ft2)
0.5 m2
(5.3 ft2)
 NT 0.045 m2
(0.4 ft2)
0.08 m2
(0.8 ft2)
0.2 m2
(2.1 ft2)
0.4 m2
(4 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 and 8]) 117 mm
(4.6 in.)
158 mm
(6.2 in.)
174 mm
(6.8 in.)
286 mm
(11.2 in.)
 
* Sanitary connection is Tri-Clamp compatible.Tri-Clamp is a trademark of Alfa Laval, Inc

 

 

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.Recommended maximum 3.5 barg (50 psig) in continuous air and gas service.KA*NT filters may be forward flow tested at 5171 mbar (75 psig) at ambient temperature.

 

 

Typical Liquid Flow Rates4

4 Typical initial clean ∆P; water at 20 °C, 1 cP.Values shown are 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

 

 
Size Code KA1 KA2 KA3 KA4
Non irradiated 7 mg 10 mg 12 mg 20 mg
Pre-sterilized  6 mg  12 mg  22 mg  不可用
 
5 Water at 20 – 25 °C after autoclaving.
N/A = Filter not available

 

 

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.Filters should be qualified in actual use.Contact 颇尔 for recommended procedures
Warning:Kleenpak filters must not be steam-sterilized in situ by passing steam through under pressure.

 

 

Sterilization

 

 
 Gamma-irradiation Maximum Dosage (G Grade)  50 kGy
 
注意事项:Contact 颇尔 for specific part number availability.
S and G grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 with with inlet and outlet options 1 and 6.
Autoclavable grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 and KA4 with with inlet and outlet options 1 and 6.

 


pall,颇尔,配UltiporN66 膜的Kleenpak囊式过滤器
上一条pall,颇尔,Ultipor N66 颗粒和生物截留滤芯,
下一条pall,颇尔,Ultipor GF Plus 过滤器滤芯,

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