Sterility Assurance Testing

What it is
To ensure that validated sterilization processes provide the required Sterility Assurance Level (SAL) either during validation or for routine process monitoring, SteriPro® Labs offer a wide range of biological indicator (BI) and product sterility assurance testing capabilities.

Why you need it
In order to label a product as "sterile," specific requirements for validation and routine monitoring of sterilization processes must be met. For most products, a theoretical SAL is set so the probability of a non-sterile product making it through the validated sterilization process is one unit per million sterilized. This is referred to as an SAL level of 10-6.

How it is done
In general, sterility assurance testing involves the following steps:

• Aseptic transfer of spored or inoculated product, biological indicators or the sterilized product itself, into a growth-enhancing medium and incubating the test articles for specific periods of time.
• After exposure, trained and certified SteriPro technicians execute testing in an appropriately controlled environment to provide accurate and reliable results.
• A report is issued at the end of the incubation period detailing whether there is growth of microorganisms in any of the test articles.
• All testing for product release is placed in test on the day of receipt, with results delivered on the last day of inoculation.
• This service includes notification of receipt of test articles and immediate communication of any results or conditions that may impact your ability to release product on time.