KVGBA04TT3

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

pore size 0.22 μm, Opticap^® XL 4

• Synonim(y): Durapore^® Capsule Filter 4 in. 0.22 µm
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: PVDF
• Poziom jakości: 400
• zgodność regionalna: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterylność: non-sterile
• Kompatybilność ze sterylizacją: autoclavable compatible
• linia produktu: Opticap^® XL 4
• Właściwości: hydrophobic
• producent / nazwa handlowa: Durapore^®
• Parametry: 25 °C max. inlet temp.; 80 psig max. inlet pressure
• metody: sterile filtration: suitable
• śr. przyłącza doprowadzającego: 1.5 in.
• śr. przyłącza odprowadzającego: 1.5 in.
• rozmiar: 4 in.
• zanieczyszczenia: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• macierz: Durapore^®
• wielkość porów: 0.22 μm pore size
• dopasowywanie: (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Opis

Opis ogólny

Device Configuration: Capsule

Inne uwagi

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.

Uwaga dotycząca przygotowania

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).

Komentarz do analizy

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

Informacje prawne

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

Oświadczenie o zrzeczeniu się odpowiedzialności

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.

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