General description
Device Configuration: Capsule
Other Notes
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Bacterial
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation and wetting sections of OPTISCALE®-25 user guide
- Storage Statement: Please refer OPTISCALE®-25 user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
Preparation Note
Sterilization Method
1 autoclave cycle of 60 min @ 123 °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
TOC/Conductivity
After sterilization and a controlled water flush of 35 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
This product was tested and passes the USP <78> test for particulates in injectables.
Legal Information
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 41104921
- Condition:
- New
- Availability:
- 3-5 Days
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- MPN:
- SHGLA25NB6
