General description
Device Configuration: Capsule
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method:
3 autoclave cycles of 60min at 126°C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(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.
Gravimetric Extractables: ≤ 10 mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 500 mL
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
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 31241800
- Condition:
- New
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- WeightUOM:
- LB
- MPN:
- KVVLA02FH3
