KGW6A04FF3

Polysep^™ II 1.0/0.5 µm nominal, Opticap^® XL Capsule

inlet connection diam. 3/4 in., Opticap^® XL 4, pore size 1.0/0.5 μm, cartridge nominal length 4 in. (10 cm)

• 동의어(들): Opticap XL4 Polysep II 1.0/0.5 μm 3/4 in. TC/TC
• UNSPSC 코드: 23151806
• eCl@ss: 32031610

속성

• material: borosilicate glass fiber (BGF) prefilter; mixed cellulose esters (MCE) ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Quality Level: 400
• 규정 준수: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 무균: non-sterile
• 멸균 적합성: autoclavable compatible
• 제품 라인: Opticap^® XL 4
• 특징: hydrophilic
• 제조업체/상표: Opticap^®
• 파라미터: 1.0 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
• 길이: 19.6 cm (7.7 in.)
• 너비: 3.3 in.
• 카트리지 공칭 길이: 4 in. (10 cm)
• 직경: 14.5 cm (5.7 in.)
• 여과 면적: 0.11 m²
• 입구 연결 직경: 3/4 in.
• 입구에서 출구 너비(W): 19.6 cm (7.7 in.)
• 출구 연결 직경: 3/4 in.
• 불순물: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 중량 추출물: ≤85 mg/capsule
• 기질: Polysep^™ II
• pore size: 1.0/0.5 μm nominal pore size; 1.0/0.5 μm pore size
• 입력: sample type liquid
• 피팅: inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

설명

일반 설명

Device Configuration: Capsule

특징 및 장점

Format: Double Layer

포장

Double Easy-Open bag

기타 정보

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.

제조 메모

Sterilization Method
3 autoclave cycles of 30 min @ 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 21 CFR 210.3 (b) (6).

분석 메모

Gravimetric Extractables: 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

법적 정보

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

Polysep is a trademark of Sigma-Aldrich Co. LLC

면책조항

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

안전성 정보

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2