CHVE75TS3

Millipore Express^® SHRP, Cartridge

pore size 0.5/0.1 μm, cartridge nominal length 5 in. (12.5 cm), Code 7, silicone seal

• 동의어(들): Millipore Express SHR Cartridge Filter 5 in. 0.5/0.1 μm Code 7 Silicone
• UNSPSC 코드: 23151806
• eCl@ss: 32031690

속성

• material: polyethersulfone ; polypropylene ; polypropylene support; polysulfone ; silicone seal
• 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: Millipore Express^®
• 특징: hydrophilic
• 제조업체/상표: Millipore Express^®
• 파라미터: ≤12.8 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); <1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 100 psi max. differential pressure (6.9 bar) at 25 °C (forward); 15 psi max. differential pressure (1.0 bar) at 135 °C (forward); 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 80 °C (forward); 30 psi max. differential pressure (2.1 bar) at 25 °C (reverse); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
• 기술: sterile filtration: suitable
• 길이: 5 in.
• 너비: 2.75 in.
• 카트리지 공칭 길이: 5 in. (12.5 cm)
• 직경: 6.9 cm (2.7 in.)
• 여과 면적: 0.23 m²
• 불순물: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 기질: Millipore Express^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• 입력: sample type liquid
• 버블 포인트(bubble point): ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• 카트리지 코드: Code 7

설명

일반 설명

Device Configuration: Cartridge

포장

Double Easy-Open bag

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 of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

제조 메모

Sterilization Method
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C and ≤ 0.35 bar (5) or 3 forward SIP cycles of 30 min @ 135 °C and 1 bar (15); 25 autoclave cycles of 60 min @ 126 °C

This product was manufactured with a Millipore Express^® 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.

TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

법적 정보

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany