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Merck
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Key Documents

K030A51TT1

Millipore

Opticap XL1 Clarigard 3.0 µm 1-1/2 in.TC/TC

inlet connection diam. 1.5 in., pore size 3.0 μm, cartridge nominal length 1 in. (2.5 cm)

别名:

Opticap® XL1 Clarigard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 23 °C
80 psig max. inlet pressure

長度

21.6 cm (8.5 in.)

柱標稱長度

1 in. (2.5 cm)

直徑

10.7 cm (4.2 in.)

入口接頭直徑

1.5 in.

入口到出口寬度

21.6 cm (8.5 in.)

出口接頭直徑

1.5 in.

雜質

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

重量法萃取物

≤10 mg/capsule

基質

Clarigard®

孔徑

3.0 μm nominal pore size
3.0 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

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
3 autoclave cycles of 30 min @ 126 °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 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

CLARIGARD 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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