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Merck
CN

KGW2A02FF3

Polysep™ II 1.0/1.2 µm nominal, Opticap® XL Capsule

inlet connection diam. 3/4 in., Opticap® XL 2, pore size 1.2/1.0 μm, cartridge nominal length 2 in. (5 cm)

别名:

Opticap XL2 Polysep II 1.0/1.2 m 3/4 in. TC/TC, Opticap XL 2 CapsuleMedia: Polysep II 1.0 / 1.2 µm Nominal

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eCl@ss:
32031610
UNSPSC Code:
23151806

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产品名称

Polysep™ II 1.0/1.2 µm nominal, Opticap® XL Capsule, Opticap® XL 2, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 3/4 in. Sanitary FlangeOutlet: 3/4 in. Sanitary FlangeMax Operating Pressure: 80 psi @ 25 °C, inlet connection diam. 3/4 in., pore size 1.2/1.0 μm, cartridge nominal length 2 in. (5 cm)

material

borosilicate glass fiber (BGF) membrane, mixed cellulose esters (MCE) membrane, 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)

Quality Level

400

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 2

feature

hydrophilic

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., 3.5 bar max. differential pressure (50 psid) at 25 °C, 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure

technique(s)

prefiltration: suitable

L

14.2 cm (5.6 in.)

W

3.3 in.

cartridge nominal length

2 in. (5 cm)

diam.

14.5 cm (5.7 in.)

filtration area

0.06 m2

inlet connection diam.

3/4 in.

inlet to outlet W

14.2 cm (5.6 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

≤45 mg/capsule

matrix

Polysep™ II

pore size

1.0/1.2 μm nominal pore size, 1.2/1.0 μm pore size

input

sample type liquid

fitting

inlet sanitary flange, outlet sanitary flange, (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

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General description

Device Configuration: Capsule

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 121 °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 a 600 mL flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
  • Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
  • 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

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC

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.

存储类别

4.1B - Flammable solid hazardous materials

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