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Merck
CN

KN50A05FF1

Opticap XL5 Polygard -CN 5.0 µm 3/4 in.TC/TC

inlet connection diam. 3/4 in., pore size 5.0 μm, cartridge nominal length 5 in. (12.5 cm)

别名:

Opticap® XL5 Polygard® CN减菌过滤器

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eCl@ss:
32031690
UNSPSC Code:
23151806

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产品名称

Opticap XL5 Polygard -CN 5.0 µm 3/4 in.TC/TC, inlet connection diam. 3/4 in., pore size 5.0 μm, cartridge nominal length 5 in. (12.5 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

21.6 cm (8.5 in.)

cartridge nominal length

5 in. (12.5 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.18 m2

inlet connection diam.

3/4 in.

inlet to outlet W

21.6 cm (8.5 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

≤25 mg/capsule

matrix

Polygard®-CN

pore size

5.0 μm nominal pore size
5.0 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

相关类别

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 ≥2 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
  • 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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