KVGBA04TT3

Hydrophobic Durapore^® 0.22 µm, Opticap^® XL Capsule

Opticap^® XL 4, pore size 0.22 μm

• Synonym(s): Durapore^® Capsule Filter 4 in. 0.22 µm
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: PVDF
• 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 4
• feature: hydrophobic
• manufacturer/tradename: Durapore^®
• parameter: 25 °C max. inlet temp.; 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• inlet connection diam.: 1.5 in.
• outlet connection diam.: 1.5 in.
• size: 4 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Durapore^®
• pore size: 0.22 μm pore size
• fitting: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

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 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.

Preparation Note

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

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.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

Durapore 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.