AAMI has just released a new edition of AAMI TIR37, “Sterilization of health care products – Radiation – Guidance on sterilization of biologics and tissue-based products.” This document is numbered TIR37:2013 even though it’s just been released this month. It supports the use of the ISO 11137 series on the sterilization of health care products using radiation. You can purchase your copy from Document Center Inc. in paper format or for pdf download. It is also available as part of our Standards Online internet access service.
As you might guess, there are unique issues for the sterilization of biologics and tissues. This Technical Information Report provides guidance on every aspect of validation, routine processing, and the maintenance of the sterilization process.
If you already use this document, you’ll want to know where the changes are. Here’s a brief synopsis of the updates:
- The scope of the standard has been expanded from human tissue-based products to “biologics and tissue-based products,” to allow for expansion of the principles of the report to other types of tissues other than human.
- There’s more information for selecting a dose establishment method. This is included in a new Annex A, to help you select processes suitable for your biologic or tissue-based product.
- The information on SIP (sample item portion) use in dose establishment has been expanded. The document notes that SIP use is not really recommended for these types of products, but it still provides you with information on what needs to be addressed should you cho0se this method anyway.
- There’s a new clause (4.4.4) on how to adopt a new product into an existing product “family.”
- More information on MPN (most probable number) testing has been added. This is a great way to get a more sensitive bioburden test with lower bioburden levels, meaning that lower sterilization doses can be established.
- Section 5.5.2 has been renumbered 5.6.2 and information on loading patterns for irradiation has been added. You’ll also get guidance on using a different container for shipment versus irradiation.
You’ll also want to note that the information in AAMI TIR37 does not address inactivating viruses and prions. You’ll use ISO 22442-3 (ANSI/AAMI/ISO 22442-3) for that.
The whole issue of the sterilization of health care products is being tested by the expansion of the products into the use of tissues and the increasing challenges of maintaining the sterile condition as products are introduced into patients. It is incumbent upon every manufacturer and health care facility to take the utmost care in this regards. And the increased standardization activity in this area shows how important this issue is to consumers and industry.
For the standards you need, use the Document Center webstore at www.document-center.com for your purchases. You’ll be amazed at the many tools available to our customers, both on the website (accessed by registration) and as additional services. For more information on how Document Center can help you collect and maintain the standards you need, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Make us your Standards Experts!
