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品質等級
法律遵循
FDA 21CFR177-182 (all component materials)
無菌
sterile; irradiated
產品線
Opticap® XL 10
特點
hydrophilic
製造商/商標名
Opticap®
參數
1 bar max. inlet pressure (15 psi) at 80 °C
25 °C max. inlet temp.
80 psig max. inlet pressure
技術
sterile filtration: suitable
柱標稱長度
10 in. (25 cm)
設備尺寸
10 in.
入口接頭直徑
3/4 in.
出口接頭直徑
9/16 in.
基質
Multilayer Durapore®
pore size
0.45/0.22 μm pore size
接頭
(19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)
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一般說明
Device Configuration: Capsule
準備報告
Sterilization Method:
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).
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).
分析報告
TOC/Conductivity: After sterilization and a controlled water flush, samples exhibited less than 500ppb TOC per USP < 643 > and less than 1.3μS/cm per USP < 645 > at 25°C.
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 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
法律資訊
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
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