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Merck
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Key Documents

KN12A10TT1

Millipore

Opticap XL10 Polygard -CN 1.2 µm 1-1/2 in.TC/TC

inlet connection diam. 1.5 in., pore size 1.2 μm, cartridge nominal length 10 in. (25 cm)

别名:

Opticap® XL10 Polygard® CN除菌过滤器

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690

材料

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)

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.
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

長度

33.5 cm (13.2 in.)

柱標稱長度

10 in. (25 cm)

直徑

10.7 cm (4.2 in.)

過濾面積

0.42 m2

入口接頭直徑

1.5 in.

入口到出口寬度

33.5 cm (13.2 in.)

出口接頭直徑

1.5 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

≤55 mg/capsule

基質

Polygard®-CN

孔徑

1.2 μm nominal pore size
1.2 μm pore size

輸入

sample type liquid

接頭

inlet sanitary flange
38 mm (1 1/2 in.) inlet/outlet sanitary flange
outlet sanitary flange

一般說明

Device Configuration: 取样皿滤膜

特點和優勢

Format: Single 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 reduction
  • 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.

聯結

Replaces: KN1201TC1

準備報告

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

分析報告

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

法律資訊

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