CLGL03TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 30 in. (75 cm), Code 0

• UNSPSC 코드: 23151806

속성

• material: PVDF membrane; polypropylene support; silicone O-ring
• 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^® II
• 기술: sterile filtration: suitable
• 길이: 30 in.
• 너비: 2.7 in.
• 카트리지 공칭 길이: 30 in. (75 cm)
• device size: 30 in.
• 여과 면적: 3.3 m²
• 불순물: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 중량 추출물: ≤30 mg/cartridge
• 기질: Durapore^® High Area
• 공극 크기: 0.22 μm pore size
• 코드: Code 0

설명

일반 설명

Device configuration: Cartridge
Cartridge type: Liquid

제조 메모

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: The extractables level was ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature. 

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