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K005A10HH1

Opticap® XL10 Clarigard®

inlet connection diam. 9/16 in., pore size 0.5 μm, cartridge nominal length 10 in. (25 cm)

別名:

Opticap XL10 Clarigard 0.5 μm 9/16 in. HB/HB, Opticap® XL10 Clarigard®

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この商品について

eCl@ss:
32031690
UNSPSC Code:
23151806
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製品名

OPTICAP® XL 10 Capsule Media: CLARIGARD® 0.5 µm Nominal, Chemistry: Polypropylene (PP)Inlet: 9/16 in. Hose BarbOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

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 23 °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.)

inlet connection diam.

9/16 in.

inlet to outlet W

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

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

gravimetric extractables

≤15 mg/capsule

matrix

Clarigard®

pore size

0.5 μm nominal pore size, 0.5 μm pore size

input

sample type liquid

fitting

inlet hose barb, 14 mm (9/16 in.) inlet/outlet hose barb, outlet hose barb

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

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).

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 ≥3 L

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.

Legal Information

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

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.

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