Tissue Sterilization

What is Tissue Sterilization? 

Tissue sterilization is the process of eliminating microbial life from human, animal, and synthetic tissues intended for transplantation or medical use. The sterilization of human, animal, and synthetic tissue products is an ever-expanding and very specialized market segment. 

Why is Tissue Sterilized? 

Tissue is sterilized to prevent the transmission of infectious diseases to recipients, which is essential for ensuring patient safety. 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. 

How is Tissue Sterilized? 

Tissue is sterilized primarily through what is known as ‘low temperature’ terminal modalities in order to prevent denaturation of proteins. This encompasses radiation modalities such as gamma, E-beam and X-ray, as well gas modalities such  ethylene oxide and VHP. The method is often chosen based on the compatibility that can further be influenced by the type of tissue and its intended use.

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:

• Cold chain processing, which provides critical temperature control pre- and post-processing
• Critical temperature control during radiation processing
• The ability to deliver extremely tight parameter ranges i.e. dose, temperature
• Rapid turnaround time (frequently same-day processing)
• Personalized service and attention at our service centers
• Technical support and product validation services 

STERIS AST Services Advantages

• Technology-neutral processing offerings, including radiation and gas technologies
• Widespread network of processing facilities
• Multi-disciplinary technical staff and on-site quality assurance personnel
• Dedicated radiation technology centers (RTCs) and EO technology centers (ETC) to support Customers through all phases of the sterilization design process 

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).