In February 2008, PMP News hosted a Webcast on ISO 11607 featuring members of the Sterilization Packaging Manufacturers Council (SPMC). Guest moderator Marie Tkacik, chairperson, SPMC Technical Committee, led fellow members as they addressed some of the standard’s more challenging aspects. The speakers were among the SPMC members who had previously authored “Complying with ISO 11607: What Will TIR 22 Do for You?, Parts 1 and 2,” in PMP News’s October 2007 and November 2007 issues.
Attendee response to the Webcast was amazing. Dozens of technical questions streamed in during the event, many more than the speakers could address in the brief Q&A session that followed. To continue the industry dialogue on ISO 11607, the speakers are answering those questions here, with their conclusions reached through group consensus. PMP News will bring more 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.com.
And if you think of another question, please feel free to submit it to PMP News through editor Daphne Allen.
General Questions on Validation
Can a packaging machinery manufacturer successfully offer a template for validating its machine?
The machinery manufacturer is in the best position to provide the critical parameters for successful machine operation. Whether or not the machine manufacturer would provide a true validation template probably depends on how familiar the manufacturer is with the medical device packaging market. In any case, it is important to get information from the machine manufacturer to successfully plan the installation qualification (IQ) and operational qualification (OQ) portions of a package manufacturing process validation.
When performing process validation for a new preformed sterile barrier system across multiple sealers (e.g., nine sealers) with little rationale for equivalence, how do I reduce sample size for performance qualification (PQ) lot runs?
The different sealers need to be evaluated for similarities, but not necessarily absolute equivalence. For example, it may be possible to group heated bar sealers together, impulse sealers together, and/or band sealers together. It is likely that the IQ and OQ work will demonstrate that there are significant similarities between some of the sealers that could be used to rationalize grouping them together for validation runs. Depending on the sealers involved, you should be able to reduce the number of groups tested to something much less than nine. Just remember to document your rationalization for doing so.
For conditioning methods (such as ISTA methods), doesn’t one need to validate that it is somehow representative of the distribution environment your package will see?
First, it is important to understand that the ISTA methods are conditioning methods or protocols rather than test methods. As such, there is no ISO 11607 requirement that they be validated. Instead, a rationale must be developed that demonstrates the applicability and appropriateness of the protocol. You need to understand the distribution environment that your packages will likely see. This is important in setting up the distribution testing of finished packages, which is required by ISO 11607. If you understand the distribution environment and can find a conditioning method or protocol that closely simulates that environment, then you could rationalize using that method as part of the distribution testing. If the distribution environment is not well understood, then it is necessary to do actual shipping tests to complete the distribution testing requirement, or, with appropriate rationale, use published data that provide information about storage and distribution environments that have been measured.
When you refer to validating the seal area, do you mean manufacturer or end-user made seals?
ISO 11607 requires that you validate the sealing process on the seals that you produce. In the case of form-fill-seal packages, the medical device manufacturer is responsible for validating all of the seals. In the case of premade sterile barrier packages, the sterile packaging manufacturer is responsible for validating the seals that it makes and the medical device manufacturer would be responsible for validating the final seal.
Can parts of this presentation be used in justifications?
Many rationales are built around published information. In consensus standard documents like ASTM F2097, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products, for example, there are applicability statements for use of each method that have been reviewed and approved through ballots to a broader community. Other sources for reference can be found in articles published in peer review or recognized trade publications. While our presentations are here to serve as guidance for decision making, it is still up to the individual or company to demonstrate that such rationale can be supported through testing.