CVGL02TP3

Durapore^® 0.22 µm, Cartridge

pore size 0.22 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• Synonim(y): Durapore Cartridge Filter 20 in. 0.22 μm Code 0, Durapore^® 0.22 µm, Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: Durapore^® Cartridge, Chemistry: 0.22 µm Hydrophilic Polyvinylidene Fluoride (PVDF)Configuration: 20 in. Code 0
• Quality Level: 400
• material: PVDF , polypropylene , polypropylene support, silicone seal
• reg. compliance: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food), meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Durapore^®, EMPROVE^® Filter
• feature: hydrophilic
• manufacturer/tradename: Durapore^®
• parameter: ≤26.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward), 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse), 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward), 50 L/min flow rate at 700 mbar (ΔP)

Opis

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °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).

Analysis Note

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 11.0 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

Other Notes

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.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Legal Information

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

Ta strona może zawierać tekst przetłumaczony maszynowo.