Merck
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KGW2A04HH3

Millipore

Opticap® XL Capsule Filter

pore size 1.2/1.0 μm, cartridge nominal length 4 in. (10 cm), filter diam. 5.7 in. (14.5 cm)

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质量水平

400

物料

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

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

4 in. (10 cm)

device L

19.6 cm (7.7 in.)

device size

4 in.

过滤器直径

5.7 in. (14.5 cm)

filter filtration area

0.11 m2

inlet connection diam.

9/16 in.

inlet to outlet width

19.6 cm (7.7 in.)

outlet connection diam.

9/16 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

1.2/1.0 μm pore size

配件

14 mm (9/16 in.) fitting (hose barb 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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 2 L
Gravimetric Extractables: ≤ 85 mg per capsule after a 1200 mL 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

Certificate of Analysis

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Certificate of Quality

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