Motion bioreactor bags are manufactured to the most exacting standards. To assure performance the customer can rely on, quality control inspections are performed from the raw material state to the final product. The entire process occurs under a quality system compliant to FDA standards.

Key Features

• Rigid plastic rods at each end 
• Gamma irradiated between 25–40 kGy 
• Manufactured under a quality system designed to be compliant to 21 CFR Part 820: Quality System Regulation
• Assembled in ISO Class 7 Clean Room
• All product contact materials USP Class VI Tested
• Full traceability for all materials
• Certificates of analysis provided for each lot
• Extractables and leachables (E&L) data available for all contact materials

Typical Applications

• Mammalian and plant culture cell lines with extended mixing times
• Growing NS0 and other cholesterol sensitive clones