Single-Use Bioprocess Systems
STERIS Isomedix Services provides contract sterilization and microbial control services for single-use bioprocess systems used in the production of biopharmaceuticals and vaccines. Our gamma irradiation services are utilized for a range of disposable bioprocess components including:
- Flexible containers/bags
- Tubing, hoses and connectors
- Membrane chromatography units
Our Radiation TechTeam provides technical support for the unique requirements of disposable bioprocess systems including protocol generation, sterilization validation and dose setting.
Click here to read the Bio-Process Systems Alliance Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems.
STERIS Isomedix Services operates under a quality system that is in compliance with 21 CFR Part 820 and applicable sections of 21 CFR Part 211. In addition, STERIS Isomedix Services is registered to the ISO 13485:2003 Quality Standard, and adheres to the requirements of ISO 11137-1:2006 (Gamma) and ISO 11135-1:2007 (EO).