CLGL01TP3

Durapore^® 0.22 µm, High Area, Cartridge

pore size 0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• 동의어(들): Durapore II Cartridge Filter 10 in. 0.22 m Code 0
• UNSPSC 코드: 23151806
• eCl@ss: 27293007

속성

• material: PVDF
• 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; steam-in-place compatible
• 제품 라인: Durapore^®
• 특징: hydrophilic
• 제조업체/상표: Durapore^® II
• 기술: sterile filtration: suitable
• 길이: 10 in.
• 너비: 2.7 in.
• 카트리지 공칭 길이: 10 in. (25 cm)
• 여과 면적: 1.1 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
• 입력: sample type liquid
• 카트리지 코드: Code 0 (2-222; O-rings)

설명

일반 설명

Device Configuration: Cartridge

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

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 a 1.5 L flush and 24 hours in water at controlled room temperature

법적 정보

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

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