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Key Documents

KWL3A04FF3

Millipore

Milligard® LPB 0.2 µm 标称, Opticap® XL 囊式

Opticap® XL 4, nominal pore size 0.2 μm, cartridge nominal length 4 in. (10 cm), filter diam. 4.9 in. (12.5 cm)

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About This Item

分類程式碼代碼:
23151806

材料

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

品質等級

法律遵循

FDA 21CFR177-182 (all component materials)

無菌

non-sterile

滅菌相容性

autoclavable compatible

產品線

Opticap® XL 4

特點

hydrophilic

製造商/商標名

Opticap®

參數

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

技術

prefiltration: suitable

柱標稱長度

4 in. (10 cm)

設備長度

19.6 cm (7.7 in.)

設備尺寸

4 in.

過濾器直徑

4.9 in. (12.5 cm)

過濾器過濾面積

0.2 m2

入口接頭直徑

3/4 in.

入口到出口寬度

19.6 cm (7.7 in.)

出口接頭直徑

3/4 in.

雜質

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

基質

Milligard® LPB

孔徑

0.2 μm nominal pore size
0.2 μm pore size

接頭

(19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

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一般說明

Device Configuration: Capsule

特點和優勢

Single Layer

包裝

Double Easy-Open bag

規格

Filter Grade: Low Protein Binding Milligard® Media

準備報告

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).

分析報告

Gravimetric Extractables: ≤ 45 mg per capsule after a 2 L flush and 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 L

其他說明

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 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

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

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