SVGLA25NB6

Durapore^® 0.22 µm, OptiScale^® Capsule

OptiScale^® 25, filtration area 3.5 cm²

• 동의어(들): Durapore^® 0.22 μm Optiscale 25mm NB
• UNSPSC 코드: 23151806
• eCl@ss: 32031610
• NACRES: NB.24

속성

• material: PVDF membrane; polypropylene ; polypropylene support; polypropylene vent cap
• 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
• 제품 라인: OptiScale^® 25
• 특징: hydrophilic
• 제조업체/상표: OptiScale^®
• 파라미터: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• 기술: sterile filtration: suitable
• 길이: 3.9 cm (1.52 in.)
• 직경: 3.1 cm (1.2 in.)
• 여과 면적: 3.5 cm²
• 불순물: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrix: Durapore^®
• 공극 크기: 0.22 μm
• 입력: sample type liquid
• 피팅: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• 배송 상태: ambient

설명

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: Bacterial
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

제조 메모

Sterilization Method
1 autoclave cycle of 60 min @ 123 °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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

법적 정보

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

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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