The sterilization of human, animal, and synthetic tissue products is an ever-expanding and very specialized market segment. Until recently, most tissue products were aseptically processed in the local tissue recovery site; however, tissue banks and tissue manufacturers have begun seeking terminal sterilization for their products due to increased regulatory scrutiny as well as the desire for cleaner and safer products.
STERIS Applied Sterilization Technologies (AST) understands the very specific requirements of this product line and is able to offer the following services to accommodate these highly valued products:
- Critical temperature control prior to and after processing
- The ability to deliver extremely tight dose ranges
- Rapid turnaround time (frequently same-day processing)
- Personalized service and attention at our service centers
- Technical consulting and product validation services
- Highest quality documentation and product processing
STERIS AST Services Advantages
- High quality, cost-effective processing
- Widespread network of sterilization facilities
- Multi-disciplinary technical staff and on-site quality assurance personnel
- Detailed certification of your medical device sterilization process
- Dedicated radiation and ethylene oxide technology centers
STERIS AST 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 is registered to the ISO 13485 Quality Standards, and adheres to the requirements of ISO 11137 (Radiation) and ISO 11135 (EO).