Complying with ISO 11607: What Will TIR 22 Do for You? Part II

The entire packaging system must be validated. Photo courtesy Beacon Converters Inc.

Continuing our review of AAMI Technical Information Report (TIR) 22, “Guidance for ANSI/ AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices, Part 1 and Part 2,” we examine the characteristics for the validation of sterile barrier system manufacturing processes and final package design validation. We also identify the cases in which revalidation is required. The process begins with manufacturing and ends with the validation of the entire packaging system design as one integral unit. The final steps for demonstrating the effectiveness of the sterile barrier system must be proven through documented validation efforts. We also define the requirements for revalidation if acceptance criteria are not satisfied or should changes occur in materials, process, or design.

In part one, we reviewed the importance of identifying the proper design inputs and selecting and evaluating the right materials to provide a foundation for designing and evaluating an effective packaging system. We also discussed the design of the sterile barrier system and protective packaging as well as packaging process feasibility and sterile barrier system design feasibility evaluation.

VALIDATION OF STERILE BARRIER SYSTEM MANUFACTURING PROCESSES

A Google search of the Internet for process validation can yield more than 70,000,000 results. Surprisingly, at the top of that search list is FDA’s Guideline on General Principles of Process Validation, originally written in 1987. While one might compare the subject of process validation to chemistry (the subject matter just doesn’t change that frequently), the new 11607-2 standard and the accompanying TIR 22 provide new clarity regarding the requirements of process validation for manufacturing processes.

The basics for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are the prerequisites for validation of sterile barrier system manufacturing processes. These topics are detailed in the standard and the TIR (Sections 11 and 12 and Annex G). The new TIR covers these issues in depth and provides step-by-step actions for engineers to follow, including the key requirements for documentation, inclusion of process stakeholders, and approvals by these same personnel. It also includes recommendations for process controls and process monitoring for the manufacturing process; these are becoming standard requirements for medical device manufacturers and their suppliers.

In the end, the output for process validation must be the same: a high degree of confidence that the manufacturing process will repeatably produce a package that meets the design specifications. The new standard and the TIR provide the medical device community a roadmap to complete this critical step successfully.

FINAL PACKAGING SYSTEM DESIGN VALIDATION

After the materials and equipment have been determined and the manufacturing process validated, it becomes time to validate the entire packaging system as a whole. This is the opportunity to prove that the entire system—process, package, sterilization, and device—can be validated as effective for the intended use.

Once again, the new TIR stresses the requirement to have a planned protocol in place, along with defined inputs, outputs, and acceptance criteria. The TIR provides the details necessary to thoroughly develop the actions and documentation to successfully prove the effectiveness of the entire system. It also includes plans for revalidation should the defined criteria not be met.

REVALIDATION

Revalidation is required when significant changes have been made to the device, the packaging system, the packaging process, or the packaging equipment. Revalidation is frequently addressed in the quality system procedures or the original validation protocol.

Periodically, the device, packaging system, packaging process, and test methods should be reviewed to evaluate whether the accumulated effect of multiple small changes results in a need for partial or total packaging system revalidation (ANSI/AAMI/ISO 11607-2:2006 Clause 5.7.4).

Conclusion

The process of designing and evaluating a sterile barrier packaging system can be complex. Fortunately, the medical device community has an established network of organizations whose members collaborate to create standards and forums that provide a compass for the navigation of this environment. The work of regulatory agencies such as FDA and organizations such as the SPMC, AAMI, ISO, IoPP, and ASTM International have all contributed to the new ISO 11607-1 and ISO 11607-2:2006 standard and the advancement of medical device packaging technology.

The addition of focused work groups such as AAMI WG7 support these standards and bring them to life for packaging professionals through the issuance of Technical Information Reports (TIR).

AAMI’s TIR22:2007 provides an excellent guide. Complex requirements of the standard are interpreted and explained to assist users in reaching compliance and consensus in the development of sterile barrier packaging systems.

The authors are all members of the Sterilization Packaging Manufacturers Council (SPMC) Technical Committee, as well as of ASTM, IoPP, and AAMI WG7 on Packaging. The SPMC is composed of leading manufacturers of sterilizable flexible packaging and materials. These companies work proactively and voluntarily as FPA-SPMC members to develop test methods and guidance documents for the flexible sterilization packaging of medical devices. SPMC member companies include Alcan Packaging, Amcor Flexibles Healthcare, Beacon Converters Inc., Oliver Medical, Perfecseal, Rollprint Packaging Products Inc., Technipaq Inc., and TOLAS Health Care Packaging. The SPMC is part of the Flexible Packaging Association. Visit the SPMC Web site at www.sterilizationpackaging.org [7].