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material

polyester support
polyethersulfone membrane
polypropylene (end cap)
polypropylene housing
polysulfone (core)

Quality Level

400

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible
gamma compatible

product line

Opticap® XL 10

feature

hydrophobic

parameter

15 psi max. pressure at 80 °C (forward)
30 psi max. pressure at 4—50 °C (reverse)
60 psi max. pressure at 4—50 °C (forward)

technique(s)

gas filtration: suitable

body diam.

10.7 cm (4.2 in.)

capsule L

33.3 cm (13.1 in.)

diam.

14.5 cm (5.7 in.) , vent to vent

filtration area

0.87 m2

inlet connection diam.

9/16 in.

outlet connection diam.

9/16 in.

impurities

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

gravimetric extractables

≤54 mg

matrix

Millipore Express® SPG

pore size

0.2 μm pore size

fitting

(14.3 mm (9/16 in.) Sanitary Flange Inlet and Outlet)

shipped in

ambient

General description

Device Configuration: Capsule

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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

Preparation Note

Sterilization Method
Gamma compatible to 40 kGy; 1 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was tested and meets requirements of USP <788> for large volume parenterals.

Analysis Note

Bacterial Retention


Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology.


Gravimetric Extractables:The extractable level was equal to or less than 27 mg/device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS 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.

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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