CGW6M4S03

Polysep^™ II 1.0/0.5 µm nominal, Cartridge

pore size 1.0/0.5 μm, cartridge nominal length 4 in. (10 cm), Code M (2-118; O-rings)

• Synonym(s): Polysep II Cartridge Filter 4 in. 0.5 μm Code M
• UNSPSC Code: 23151806
• eCl@ss: 32031610

Properties

• material: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene ; polypropylene support (Spun bonded); silicone seal
• Quality Level: 400
• reg. compliance: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food); 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: Polysep^™
• feature: hydrophilic
• manufacturer/tradename: Polysep^™
• parameter: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• technique(s): prefiltration: suitable
• L: 4 in.
• W: 2.7 in.
• cartridge nominal length: 4 in. (10 cm)
• diam.: 7.1 cm (2.8 in.)
• filtration area: 0.19 m²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤56 mg/cartridge
• matrix: Polysep^™ II
• pore size: 1.0/0.5 μm nominal pore size; 1.0/0.5 μm pore size
• input: sample type liquid
• cartridge code: Code M (2-118; O-rings)

Description

General description

Device Configuration: Cartridge

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Other Notes

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
• Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sanitization Protocol
30 min with hot water @ 80 °C

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

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).

Analysis Note

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Legal Information

Polysep is a trademark of Sigma-Aldrich Co. LLC

Safety Information

• pictograms: GHS02
• signalword: Danger
• hcodes: H228
• pcodes: P210 - P240 - P241 - P280 - P370 + P378
• Hazard Classifications: Flam. Sol. 1
• Storage Class: 4.1B - Flammable solid hazardous materials
• wgk_germany: WGK 2