K010A10TT1

Opticap^® XL10 Clarigard^®

inlet connection diam. 1.5 in., pore size 1.0 μm, cartridge nominal length 10 in. (25 cm)

• Synonim(y): Opticap XL10 Clarigard 1.0 μm 1-1/2 in. TC/TC
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Poziom jakości: 400
• zgodność regionalna: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• producent / nazwa handlowa: Opticap^®
• Parametry: 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.; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Długość: 33.5 cm (13.2 in.)
• długość nominalna kartridża: 10 in. (25 cm)
• Średnica: 10.7 cm (4.2 in.)
• śr. przyłącza doprowadzającego: 1.5 in.
• szer. od złącza doprowadzającego do złącza odprowadzającego: 33.5 cm (13.2 in.)
• śr. przyłącza odprowadzającego: 1.5 in.
• zanieczyszczenia: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤15 mg/capsule
• macierz: Clarigard^®
• wielkość porów: 1.0 μm nominal pore size; 1.0 μm pore size
• moc wejściowa: sample type liquid
• dopasowywanie: inlet sanitary flange; 38 mm (1 1/2 in.) inlet/outlet sanitary flange; outlet sanitary flange

Opis

Opis ogólny

Device Configuration: Capsule

Opakowanie

Double Easy-Open bag

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

Sterilization Method
3 autoclave cycles of 30 min @ 126 °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).

Komentarz do analizy

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

Informacje prawne

CLARIGARD 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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