LAHL04TP6

Durapore^® 0.45 µm with Prefilter, Optiseal^® Cartridge

OptiSeal^® 4 in., filtration area 0.18 m², matrix Durapore^® (w/Prefilter)

• Synonim(y): Optiseal Durapore Cartridge Filter 0.45 μm with prefilter
• Kod UNSPSC: 23151806
• eCl@ss: 32031690

Właściwości

• Materiały: PVDF ; mixed cellulose esters (MCE) prefilter; polypropylene ; polypropylene support; silicone seal
• 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; steam-in-place compatible
• linia produktu: OptiSeal^® 4 in.
• Właściwości: hydrophilic
• producent / nazwa handlowa: OptiSeal^®
• Parametry: ≤4 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. differential pressure (50 psid) at 80 °C (Forward); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• metody: bioburden reduction: suitable
• Długość: 4 in.
• długość nominalna kartridża: 4 in. (10 cm)
• powierzchnia filtracyjna: 0.18 m²
• zanieczyszczenia: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• substancje ekstrahujące się grawimetrycznie: ≤15 mg/cartridge
• Matryca: Durapore^® (w/Prefilter)
• wielkość porów: 0.45 μm
• moc wejściowa: sample type liquid
• punkt pęcherzykowania: ≥1930 mbar (28 psig), air with water at 23 °C
• kod wkładu: not applicable

Opis

Opis ogólny

Device Configuration: Cartridge

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 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.

Uwaga dotycząca przygotowania

Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min

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

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

Informacje prawne

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

OPTISEAL is a registered trademark of Merck KGaA, Darmstadt, Germany

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Informacja o środkach bezpieczeństwa

• Kod klasy składowania: 4.1B - Flammable solid hazardous materials
• Klasa zagrożenia wodnego (WGK): WGK 3