CMP473TS1

Milligard^® PES 1.2/0.45 µm, Cartridge

pore size 1.2/0.45 μm, cartridge nominal length 30 in. (75 cm)

• Synonym(s): Milligard PES 30" 1.2/0.45 μm Cartridge
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• material: polyethersulfone membrane; polypropylene housing; polypropylene support; polypropylene vent cap
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible; steam-in-place compatible
• product line: EMPROVE^® Filter; Milligard^®
• feature: hydrophilic
• manufacturer/tradename: 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)
• technique(s): prefiltration: suitable
• L: 31.8 in.
• W: 2.7 in.
• cartridge nominal length: 30 in. (75 cm)
• diam.: 69 mm (2.71 in.)
• filtration area: 1.8 m²
• impurities: <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: 1.2/0.45 μm pore size
• input: sample type liquid
• cartridge code: Code 7

Description

General description

Device Configuration: Cartridge

Preparation Note

Sterilization Method
Autoclave wet 25x, 60 minute cycles at 128°C. In-line steam (wet): 10 forward cycles, 30 min.,
135 °C at ≤0.34 bar (5 psid) and 5 reverse cycles,
30 min., 135 °C at ≤0.07 bar (<1 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).

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 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.

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.

Legal Information

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

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