Merck
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KGW9A2ZTT1

Millipore

Opticap® XL Capsule Filter

pore size 2.0/1.2 μm, cartridge nominal length 20 in. (50 cm)

物料

borosilicate glass fiber (BGF) prefilter
polypropylene filter
polypropylene housing
polypropylene support
silicone seal

质量水平

400

reg. compliance

FDA 21CFR177-182 (all component materials)

manufacturer/tradename

Opticap®

参数

1 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

cartridge nominal length

20 in. (50 cm)

device size

20 in.

inlet connection diam.

1-1/2 in.

outlet connection diam.

1-1/2 in.

杂质

≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)

基质

Polysep II

pore size

2.0/1.2 μm pore size

配件

38 mm (1 1/2 in.) fitting (sanitary flange inlet/oulet)

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一般描述

Device Configuration: Capsule

特点和优势

Double Layer

包装

Double Easy-Open bag

制备说明

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

分析说明

Gravimetric Extractables: ≤ 290 mg per capsule after a 10 L flush and 24 hours in water at controlled room temperature.

其他说明

Directions for Use:

  • Organism Retention: Microorganism
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法律信息

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Merck KGaA, Darmstadt, Germany

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