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KGW3A05FF1

Millipore

Polysep™ II 1.0/0.2 µm nominal, Opticap® XL Capsule

Opticap® XL 5, inlet connection diam. 3/4 in., pore size 1.0/0.2 μm, cartridge nominal length 5 in. (12.5 cm)

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Synonym(s):
Opticap XL5 Polysep II 1.0/0.2 μm 3/4 in. TC/TC
eCl@ss:
32031610

material

borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Quality Level

400

reg. compliance

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

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible

product line

Opticap® XL 5

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

21.6 cm (8.5 in.)

W

4.2 in.

cartridge nominal length

5 in. (12.5 cm)

diam.

14.5 cm (5.7 in.)

filtration area

0.19 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

≤61 mg/capsule

matrix

Polysep™ II

pore size

1.0/0.2 μm nominal pore size
1.0/0.2 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

Other Notes

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 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.

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 5 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

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.

Storage Class Code

11 - Combustible Solids

WGK

WGK 2

Regulatory Information

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