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Key Documents

KVGBA10HH1

Millipore

Opticap 除菌级 XL10 Durapore 疏水性 0.22 µm 9/16 in.HB/HB

inlet connection diam. 9/16 in., Opticap® XL 10, pore size 0.22 μm, cartridge nominal length 10 in. (25 cm)

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

材料

PVDF
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

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 10

特點

hydrophobic

製造商/商標名

Opticap®

參數

≤10 mL/min nitrogen diffusion at 1.7 bar (25 psig) and 23 °C (with 60/40% IPA/water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.4 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 23 °C
80 psig max. inlet pressure

技術

sterile filtration: suitable

長度

13.2 in.

寬度

4.2 in.

柱標稱長度

10 in. (25 cm)

直徑

14.5 cm (5.7 in.)

過濾面積

0.69 m2

入口接頭直徑

9/16 in.

入口到出口寬度

33.3 cm (13.1 in.)

出口接頭直徑

9/16 in.

雜質

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

基質

Durapore®

孔徑

0.22 μm pore size

起泡點

≥1240 mbar (18 psig), nitrogen with 60/40% IPA/water at 23 °C

接頭

1/4 in. drain/vent hose barb (with double O-ring Seal)
(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

一般說明

Device Configuration: 取样皿滤膜

包裝

Double Easy-Open bag

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

Sterilization Method
20 autoclave cycles of 30 min @ 126 °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 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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