General description
Device Configuration: Cartridge
Cartridge Type: Liquid
Filter Grade: Prefilter
Application
mAb & r-protein intermediates; Plasma; Vaccines & viral vectors; SVPs LVPs; Cell Culture; Media Filtration; Colloid Removal; Lipid Removal
Features and Benefits
Format: Double Layer
Packaging
Double Easy-Open bag
Preparation Note
Sanitization: 30 min with hot water at 80 °C
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a Millipore® media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Analysis Note
After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature, extractables level was ≤140 mg per 10-inch element after a 5000 mL flush.
Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of 5000 mL per 10 inch Element
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 first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
- Storage Statement: Please refer Mixed cellulose esters Tech Brief
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
The product is manufuactured in a facility with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard.
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 41104908
- Condition:
- New
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- WeightUOM:
- LB
- MPN:
- CGW904S01
