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Merck
CN

KN12A10FF1

Opticap® XL10 Polygard® CN除菌过滤器

inlet connection diam. 3/4 in., pore size 1.2 μm, cartridge nominal length 10 in. (25 cm)

别名:

Opticap XL10 Polygard CN 1.2 μm 3/4 in. TC/TC

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eCl@ss:
32031690
UNSPSC Code:
23151806

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产品名称

Opticap® XL10 Polygard® CN除菌过滤器, inlet connection diam. 3/4 in., pore size 1.2 μm, cartridge nominal length 10 in. (25 cm)

material

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

reg. compliance

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

manufacturer/tradename

Opticap®

parameter

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

L

33.5 cm (13.2 in.)

cartridge nominal length

10 in. (25 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.42 m2

inlet connection diam.

3/4 in.

inlet to outlet W

33.5 cm (13.2 in.)

outlet connection diam.

3/4 in.

impurities

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

gravimetric extractables

≤55 mg/capsule

matrix

Polygard®-CN

pore size

1.2 μm nominal pore size
1.2 μm pore size

input

sample type liquid

fitting

inlet sanitary flange
19 mm (3/4 in.) inlet/outlet sanitary flange
 outlet sanitary flange

Quality Level

400

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General description

Device Configuration: 取样皿滤膜

Analysis Note

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

Disclaimer

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.

Features and Benefits

Format: Single Layer

Other Notes

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.

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

Packaging

Double Easy-Open bag

Preparation Note

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

Legal Information

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

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