CGW204S03

Polysep^™ II 1.0/1.2 µm nominal, Cartridge

pore size 1.2/1.0 μm, filter diam. 7.1 cm (2.8 in.), cartridge nominal length 100 cm (40 in.)

• UNSPSC 코드: 23151806

속성

• material: borosilicate glass fiber (BGF) prefilter; polypropylene prefilter; polypropylene support; silicone seal
• Quality Level: 400
• 규정 준수: meets FDA 21 CFR 177-182 (all component materials)
• 무균: non-sterile
• 멸균 적합성: autoclavable compatible; steam-in-place compatible
• 제품 라인: Polysep^™
• 특징: hydrophilic
• 제조업체/상표: Polysep^™
• 파라미터: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• 기술: prefiltration: suitable
• 길이: 40 in.
• 너비: 2.7 in.
• 카트리지 공칭 길이: 100 cm (40 in.)
• 필터 직경: 7.1 cm (2.8 in.)
• filter filtration area: 1.84 m²
• 불순물: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction ); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction )
• 기질: Polysep^™ II
• pore size: 1.0/1.2 μm nominal pore size; 1.2/1.0 μm pore size
• 카트리지 코드: Code 0

설명

일반 설명

Device Configuration: Cartridge

특징 및 장점

Double Layer

포장

Double Easy-Open bag

제조 메모

Non-Fiber Releasing: This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

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

분석 메모

Gravimetric Extractables: the extractables level was equal to or less than 140 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 20 L

기타 정보

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

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

법적 정보

Polysep is a trademark of Sigma-Aldrich Co. LLC