KVGLA05TT1

Durapore^® 0.22 µm, Opticap^® XL Capsule

Opticap^® XL, inlet connection diam. 1.5 in.

• Synonym(s): Opticap XL5 Durapore 0.22 μm 1-1/2 in. TC/TC
• UNSPSC Code: 23151806

Properties

• Product Name: Durapore^® 0.22 µm, Opticap^® XL Capsule, Opticap^® XL, inlet connection diam. 1.5 in.
• Quality Level: 400
• material: PVDF membrane; polypropylene housing; polypropylene support; polypropylene vent cap; silicone O-ring; silicone seal
• 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
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• parameter: 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 23 °C
• technique(s): sterile filtration: suitable
• device L: 5 in. (12.5 cm)
• filtration area: 0.35 m²
• inlet connection diam.: 1.5 in.
• inlet to outlet W: 21.6 cm (8.5 in.)
• outlet connection diam.: 1.5 in.
• impurities: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤15 mg/capsule
• matrix: Durapore^®
• pore size: 0.22 μm
• input: sample type liquid
• bubble point: ≥3450 mbar (50 psig), air with water at 23 °C
• fitting: 38 mm (1 1/2 in.) inlet sanitary flange; 38 mm (1 1/2 in.) outlet sanitary flange

Description

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: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

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.

General description

Device Configuration: Capsule

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 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.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable

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).

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