MILLIPORE EXPRESS SHR OPTISCALE 25MM 0.1UM NB 6/PK

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: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• 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 to 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 Millipore Express 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 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

Legal Information

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany