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Key Documents

KGW2A02HH3

Millipore

Polysep II 1.0/1.2 µm nominal, Opticap® XL Capsule

Opticap® XL 2, inlet connection diam. 9/16 in., pore size 1.2/1.0 μm, cartridge nominal length 2 in. (5 cm)

同義詞:

Opticap XL2 Polysep II 1.0/1.2 μm 9/16 in. HB/HB

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031610

材料

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
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 2

特點

hydrophilic

製造商/商標名

Opticap®

參數

1.0 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

長度

14.2 cm (5.6 in.)

寬度

3.3 in.

柱標稱長度

2 in. (5 cm)

直徑

14.5 cm (5.7 in.)

過濾面積

0.06 m2

入口接頭直徑

9/16 in.

入口到出口寬度

14.2 cm (5.6 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)

重量法萃取物

≤45 mg/capsule

基質

Polysep II

pore size

1.0/1.2 μm nominal pore size
1.2/1.0 μm pore size

輸入

sample type liquid

接頭

inlet hose barb
outlet hose barb
(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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一般說明

Device Configuration: 取样皿滤膜

特點和優勢

Format: Double Layer

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

準備報告

Sterilization Method
3 autoclave cycles of 30 min @ 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 21 CFR 210.3 (b) (6).

分析報告

Gravimetric Extractables: after a 600 mL 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

法律資訊

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

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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儲存類別代碼

11 - Combustible Solids

水污染物質分類(WGK)

WGK 2


分析證明 (COA)

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