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Durapore^® 0.22 µm, Opticap^® XLT Capsule

Opticap^® XLT 10, inlet connection diam. 1.5 in., cartridge nominal length 10 in. (25 cm)

• 동의어(들): Opticap Gamma Compatible XLT10 Durapore 0.22 μm 1-1/2 in. TC
• UNSPSC 코드: 23151806

속성

• material: PVDF ; polyester support; polyethylene support; polypropylene (gamma-stable); polypropylene housing; 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: gamma compatible
• 제품 라인: Opticap^® XLT 10
• 특징: gamma compatible; hydrophilic
• 제조업체/상표: Opticap^®
• 파라미터: ≤14 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 2.8 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 (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• 기술: sterile filtration: suitable
• 길이: 37.6 cm (14.8 in.)
• 너비: 6.0 in.
• 카트리지 공칭 길이: 10 in. (25 cm)
• 직경: 10.7 cm (4.2 in.)
• 여과 면적: 0.73 m²
• 입구 연결 직경: 1.5 in.
• 입구에서 출구 너비(W): 15.2 cm (6.0 in.)
• 출구 연결 직경: 1.5 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: ≤25 mg/capsule
• 기질: Durapore^®
• 공극 크기: 0.22 μm
• 입력: sample type liquid
• 버블 포인트(bubble point): ≥3450 mbar (50 psig), air with water at 23 °C
• 피팅: 1/4 in. drain/vent hose barb (with double O-ring Seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

설명

일반 설명

Device Configuration: Capsule

T-line/Gauge Port: T-line

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

제조 메모

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

분석 메모

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

법적 정보

ASTM is a registered trademark of American Society for Testing and Materials

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

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

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.