CMP271TS1

Milligard^® PES, 1,2/0,2 µm nominal, Kartusche

pore size 1.2/0.2 μm, cartridge nominal length 10 in. (25 cm)

• Synonym(e): Milligard PES 10" 1.2/0.2 nominal um Cartridge
• UNSPSC-Code: 23151806
• eCl@ss: 32031690

Eigenschaften

• Materialien: polyethersulfone membrane; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Qualitätsniveau: 400
• Einhaltung gesetzlicher Vorschriften: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilität: non-sterile
• Kompatibilität mit Sterilisationsverfahren: autoclavable compatible; steam-in-place compatible
• Produktlinie: EMPROVE^® Filter; Milligard^®
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Milligard^®
• Parameter: 1.38 bar max. differential pressure (20 psid) at 25 °C (Reverse); 5.52 bar max. differential pressure (80 psid) at 4-25 °C (Forward)
• Methode(n): bioburden reduction: suitable
• Länge: 317.5 mm (12.5 in.)
• Breite: 2.7 in.
• Nennlänge Kartusche: 10 in. (25 cm)
• Durchmesser: 69 mm (2.71 in.)
• Filtrationsfläche: 0.6 m²
• Verunreinigungen: <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
• Matrix: Milligard^® PES
• pore size: 1.2/0.2 μm nominal pore size; 1.2/0.2 μm pore size
• Aufnahme: sample type liquid
• Kartuschencode: Code 7

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filterelement

Sonstige Hinweise

The product is manufactured in a facility which adheres to Good Manufacturing Practices. The manufacturing facility’s Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Standard.

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 of Filters with MILLIGARD^® PES Membrane user guide
• Storage Statement: Please refer Filters with MILLIGARD^® PES Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Angaben zur Herstellung

Sterilization Method
Autoclave wet 25x, 60 minute cycles at 128 °C. Or in-line steam (wet) 10 forward cycles, 30 minutes ≤ 135 °C at ≤ 4 psid and 5 reverse cycles, 30 min., ≤ 135 °C at <1.0 psid*.

*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.

This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Rechtliche Hinweise

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

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