一般描述
Device Configuration: Cartridge
包装
Double Easy-Open bag
其他说明
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.
制备说明
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).
分析说明
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 16.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L