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Key Documents

KN06A10FF1

Millipore

Opticap® XL Capsule Filter

pore size 0.6 μm, cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

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About This Item

分類程式碼代碼:
23151806

材料

polypropylene filter
polypropylene housing
polypropylene support
silicone seal

品質等級

法律遵循

meets FDA 21 CFR 177-182 (all component materials)

製造商/商標名

Opticap®

參數

max. inlet temp. at 25 °C
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

柱標稱長度

10 in. (25 cm)

設備尺寸

10 in.

過濾器長度

13.2 in. (33.5 cm)

過濾器直徑

4.2 in. (10.7 cm)

過濾器過濾面積

0.42 m2

入口接頭直徑

3/4 in. , sanitary flange

入口到出口寬度

33.5 cm (13.2 in.)

雜質

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

基質

Polygard®-CN

孔徑

0.6 μm pore size

接頭

inlet/outlet connection for 19 mm (3/4 in.) sanitary flange

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一般說明

Cartridge Type: Liquid
Device Configuration: Capsule

特點和優勢

Format: Single Layer

包裝

Double Easy-Open bag

準備報告

Sterilization Method:
3 autoclave cycles of 30min at 126°C; not in-line steam sterilizable

分析報告

Gravimetric Extractables: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5L

其他說明

Directions for Use:
  • Organism Retention: Microorganism reduction
  • Mode of Action: Filtration (size exclusion)
  • Applicaiton: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer to installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法律資訊

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

儲存類別代碼

10-13 - German Storage Class 10 to 13


分析證明 (COA)

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