WEBCAST WRAP UP
The Sterilization Packaging Manufacturers Council (SPMC) is addressing a number of questions presented to them during their February 2008 Webcast, “Understanding the Nuances of ISO 11607.” PMP News will bring these answers to you in this and future issues. You may also find a complete list of questions and answers at the SPMC Web site at www.sterilizationpackaging.org and at www.pmpnews.com.
I have a product in development that is still in the concept phase. Right now it seems too early to include a packaging manufacturer. Wouldn’t it make better sense to do this after product design?
No, it is definitely not too early. In many cases, it is a perfect time to start working with your packaging supplier. Ideally, the two paths of developing the device and the package with the device should run concurrent to one another. You can evaluate the material compatibility with the device and any special requirements for shielding and sterilization in the development phase.
You can also discuss options regarding the best type of package for this product, the ramifications of cost, how the end-use customer perceives the packaging materials, and many other features more easily designed into the package if known early during the product design phase. The bottom line is that the earlier the sterile packaging manufacturer (SPM) gets involved, the more likely you are to optimize package performance as well as cost.
Are the ISO 11607, AAMI, and ASTM International standards equally recognized and applied globally?
ISO 11607, also referred to as ISO/EN 11607, is a European norm, as it supports the European Device Directive, and conformance to it is required in the EU. Outside of the EU, the ISO standards take a number of different roles. Within the United States, FDA has a standard recognition process that acknowledges standards and publishes them as such in the Federal Register. Once a standard has undergone this process, it becomes official guidance of FDA.
ANSI/AAMI/ISO 11607–1:2006 and ANSI/AAMI/ISO 11607–2:2006, for instance, are recognized standards and were included on FDA’s Recognition List published in the September 12, 2007, Federal Register.
The ISO standards outside of the EU and the United States can be recognized in one of three ways:
- Completely as a guidance document, with no official recognition.
- As official guidance from a regulatory body within a country.
- Can be adopted as a requirement just like ISO 11607 in the EU.
This depends on the individual country, and there is no established pattern. For further information on the regulatory agencies in a specific country, please see Annex A of TIR 22:2007. ASTM and AAMI documents are referenced in and support the work to be accomplished in complying with ISO 11607.
Can’t I just get a package that is already validated?
You may be able to get close to that if you have other very similar products. You can use a product family validation and that would make life relatively simple. You really can’t get a package that is fully prevalidated, though, because it’s not just the package that is being validated. It is a package and product combination, and that combination is designed for a specific sterilization procedure and a specific set of distribution requirements. All of those requirements together make up the total validation.
