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Merck
CN

KVSSA10FF1

Millipore

Opticap® XL胶囊过滤器

cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

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物料

mixed cellulose esters (MCE) prefilter
polypropylene filter
polypropylene housing
polypropylene support
silicone seal

质量水平

400

管理合规性

FDA 21CFR177-182 (all component materials)

特点

hydrophilic

制造商/商品名称

Opticap®

参数

≤10.8 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
1 bar max. inlet pressure (15 psi) at 80 °C
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward:)
2.8 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 (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:)
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

纯化柱标称长度

10 in. (25 cm)

设备长度

33.0 cm (13.0 in.)

设备尺寸

10 in.

过滤器直径

4.2 in. (10.7 cm)

过滤器过滤面积

0.34 m2

入口接头直径

3/4 in.

出口接头直径

3/4 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

Multimedia Durapore®

孔径

0.2 μm pore size
0.22 μm pore size
0.5 μm pore size

泡点

≥3450 mbar (50 psig), air with water at 23 °C

配件

19 mm (3/4 in.) fitting (sanitary flange inlet/oulet)
1/4 in. fitting (vent/drain hose barb with double O-ring seal)

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一般描述

Device Configuration: Capsule

包装

Double Easy-Open bag

制备说明

Sterilization Method:
3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable

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

分析说明

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.
Gravimetric Extractables: ≤ 75 mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 L

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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

法规信息

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