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
제품 라인
Opticap® XL 4
특징
hydrophobic
제조업체/상표
Durapore®
파라미터
25 °C max. inlet temp.
80 psig max. inlet pressure
기술
sterile filtration: suitable
입구 연결 직경
1.5 in.
출구 연결 직경
1.5 in.
크기
4 in.
불순물
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
기질
Durapore®
공극 크기
0.22 μm pore size
피팅
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
일반 설명
Device Configuration: Capsule
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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules 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.
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.
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