Gamma Irradiated refers to a product that has been irradiated at some predetermined dose which is felt to kill the bioburden. Sterility testing is usually not performed nor quarterly audits for continued validation. The Sterility Assurance Level (SAL) cannot be predicted. A higher dose of radiation may be delivered to the product than may not be necessary. This could potentially cause physical damage to the product.
Sterile refers to a product that is validated sterile. ANSI/AAMI/ISO procedures have been followed for verification of irradiation dose with quarterly audits being performed to monitor bioburden levels of dose. The Sterility Assurance Level (SAL) can be determined and is 10¯6 (which is the chance of 1 non-sterile unit in 1,000,000)
Please read our Technical Brief, “When It Has to Be Sterile…..” We spell out important information regarding the documentation you must require when purchasing a “Validated Sterile” product.
Another important aspect of a Validated Sterile product is Package Validation. Package Validation is the key to maintaining the integrity of your product. Material compatibility, package sealing, barrier performance are just some of the key aspects that must be evaluated for the packaging. Berkshire’s packaging validation is performed on sterilized packaging according to ASTM F1140-00: Standard Test Method for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications. Berkshire performs Burst Testing Sterility Validations to support the Validation Program. As long as the package has not been compromised, your product is validated sterile.
Some Questions To Think About:
1. Does your wiper manufacturer have an approved US located irradiator that they audit on a consistent basis looking at equipment and process validation?
2. Is there a Dose Distribution Study showing dose mapping to determine minimum and maximum absorbed dose positions?