추천 제품
material
PVDF
Quality Level
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®
EMPROVE® Filter
특징
hydrophilic
제조업체/상표
Durapore®
기술
sterile filtration: suitable
길이
10 in.
너비
2.7 in.
카트리지 공칭 길이
10 in. (25 cm)
여과 면적
0.69 m2
불순물
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
중량 추출물
≤20 mg/cartridge
기질
Durapore®
공극 크기
0.22 μm
입력
sample type liquid
카트리지 코드
Code 7 (2-226; O-rings w/locking-tabs)
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.
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
법적 정보
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
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