KGW2A04HH3

Polysep^™ II 1.0/1.2 µm nominal, Opticap^® XL Capsule

pore size 1.2/1.0 μm, Opticap^® XL 4, filter diam. 5.7 in. (14.5 cm), cartridge nominal length 4 in. (10 cm)

• UNSPSC 코드: 23151806

속성

• material: borosilicate glass fiber (BGF) membrane; mixed cellulose esters (MCE) membrane; polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• Quality Level: 400
• 규정 준수: FDA 21CFR177-182 (all component materials)
• 무균: non-sterile
• 멸균 적합성: autoclavable compatible
• 제품 라인: Opticap^® XL 4
• 특징: hydrophilic
• 제조업체/상표: Opticap^®
• 파라미터: 1 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• 기술: prefiltration: suitable
• 카트리지 공칭 길이: 4 in. (10 cm)
• device L: 19.6 cm (7.7 in.)
• device size: 4 in.
• 필터 직경: 5.7 in. (14.5 cm)
• filter filtration area: 0.11 m²
• 입구 연결 직경: 9/16 in.
• inlet to outlet width: 19.6 cm (7.7 in.)
• 출구 연결 직경: 9/16 in.
• 불순물: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL 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
• 피팅: (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

설명

일반 설명

Device Configuration: Capsule

특징 및 장점

Double Layer

포장

Double Easy-Open bag

제조 메모

Sterilization Method:
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable

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).

분석 메모

Gravimetric Extractables: ≤ 85 mg per capsule after a 1200 mL flush and 24 hours in water at controlled room temperature.

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

법적 정보

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

Polysep is a trademark of Sigma-Aldrich Co. LLC