Milli-Q® Lab Water Solutions
Opticap® XL4 Durapore® 0.22 µm 1/4 in. NPT/NPT
Each
- Product overview
General description
Device Configuration: Capsule
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method
3 autoclave cycles of 60 min @ 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 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.
Gravimetric Extractables: 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.
Replaces: KVGL04NP3
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
AFS is a registered trademark of Merck KGaA, Darmstadt, Germany
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
Disclaimer
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
