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
Filtration
Membrane chromatography units
Sensors

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.

All gamma and EO facilities are in compliance with FDA 21 CFR part 820 requirements, ISO 13485 registered, and AAMI/ANSI/ISO 11135-1:2007, AAMI/ANSI/ISO 11137-1:2006, and EN 550 compliant for product acceptance in U.S. and international markets.