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Key Documents

KVGBA04HH3

Millipore

Durapore® 囊式过滤器 4 in.0.22 µm

Opticap® XL 4, pore size 0.22 μm

别名:

疏水性Durapore® 0.22 µm,Opticap® XL囊式

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690

材料

PVDF

品質等級

法律遵循

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

無菌

non-sterile

滅菌相容性

autoclavable compatible

產品線

Opticap® XL 4

特點

hydrophobic

製造商/商標名

Durapore®

參數

25 °C max. inlet temp.
80 psig max. inlet pressure

技術

sterile filtration: suitable

入口接頭直徑

9/16 in.

出口接頭直徑

9/16 in.

尺寸

4 in.

雜質

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

基質

Durapore®

孔徑

0.22 μm pore size

接頭

(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

一般說明

Device Configuration: 取样皿滤膜

其他說明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

準備報告

This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析報告

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.

法律資訊

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

免責聲明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

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