CHGL02TP3

Multilayer Durapore^® 0.45/0.22 µm, Cartridge

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 0

• UNSPSC 코드: 23151806

속성

• material: polypropylene device; 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: Durapore^®
• 특징: hydrophilic
• 제조업체/상표: Durapore^®
• 파라미터: ≤21.6 mL/min air diffusion at 2.75 bar (40 psig) (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (reverse; intermittent); 3.5 bar max. inlet temp. (50 psi) 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 25 °C (forward)
• 기술: sterile filtration: suitable
• 길이: 20 in.
• 너비: 2.7 in.
• 카트리지 공칭 길이: 20 in. (50 cm)
• device size: 20 in.
• 필터 직경: 2.7 in. (6.9 cm)
• filter filtration area: 1.1 m²
• 불순물: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 기질: Multilayer Durapore^®
• pore size: 0.45/0.22 μm pore size
• 버블 포인트(bubble point): ≥3450 mbar (50 psig), air with water
• 코드: Code 0

설명

일반 설명

Device configuration: Cartridge
Cartridge type: Liquid

제조 메모

Sterilization Method: 30 SIP cycles of 30 min at 135°C; 30 autoclave cycles of 60 min at 126°C

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.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 3L

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 to 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

법적 정보

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

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