REGULATION AND STANDARDS
DDL Inc., Eden Prairie, Minnesota, USA
New validation requirements
The ISO 11607 standard is the foremost guidance document for validating packaging for terminally sterilised medical devices. In June 2006, important revisions were made to ISO 11607, which reinforce compliance requirements for medical device package validation. Manufacturers must now more than ever become familiar with the new ISO 11607-01 standard to ensure that their packaging complies, so that their medical devices are delivered to market in a timely fashion. Some of the questions raised during a series of Webinars on the revisions to the ISO 11607 standard are answered here.
Why was the ISO 11607 standard revised? The main reason was to harmonise ISO 11607 with the European packaging standard EN 868-1. This has been a goal of the international and European standards bodies, ISO and CEN, respectively, since the development of these standards began. Previously, ISO 11607 covered materials, the way in which the package is formed and the final package. The previous EN 868-1 standard covered packaging materials and the design of the final package. The merged ISO 11607-01 covers all of this: materials, manufacturing, and package design requirements for terminally sterilised medical device packaging.
What are the biggest changes to the ISO 11607 standard? The most affected section of the ISO 11607 standard is Clause 6, which focusses on a package’s ability to deliver a medical device to the patient without jeopardising sterility or incurring defect. The revisions to Clause 6 affect
• compliance requirements for test methods
• sampling plans
• performed sterile barrier systems
• storage and transportation regulations
• closure and seal evaluation
• accelerated ageing protocols.
The addition and elimination of many terms and the removal of compliance responsibilities from the new ISO 11607-01 standard may create some confusion. Uncertainty is also likely to arise over certain areas of responsibility such as:
• Who should test the packaging suppliers’ seals?
• Who is responsible for validating package-sealing equipment?
• Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?
The medical device manufacturer must determine from the outset the roles and responsibilities of contractors and vendors in the entire package development and validation process.
Is it necessary to redo previous package validations to comply with the new standard? No. Any validations that have already been completed or are in process do not need to be redone. Future validations must of course incorporate the provisions of the new standard.
Why does testing have to be performed at every stage of packaging? Current practice usually combines processes and only tests at certain points. Performing seal strength and integrity testing at every step of the packaging validation process helps determine the root cause of any failures. If these interval tests are not performed and left until the end and a failure is found, it is extremely difficult to determine at which point and under what stress the failure actually occurred; hence it makes it difficult to take corrective action.
It was mentioned during the Webinar that testing should be conducted on a product produced at “worst case” parameters not at nominal. Is this a recommendation or a requirement? This is a requirement. The thought process here is that if the sealing machines are operating within the established control parameters, but at the upper or lower extremes of the range, then there are many packages being produced that meet production quality requirements that may be somewhat weak relative to the dynamics that will occur during shipping and handling. These packages must reach the final end use without breaches in the sterile barrier system.
Why do you recommend the accelerated ageing test be conducted separately from the distribution simulation test? The order of testing has changed from that specified under the last ISO 11607 standard. The current ASTM F1980-02, Standard Guide for Accelerated Ageing of Sterile Medical Device Packages, is also under revision and is not yet released. It is expected that the new F1980 standard will have a flowchart to depict the new ISO 11607 standard.
Conclusion
Most of the changes to the ISO 11607 standard will have little effect on how packaging and sterile barrier systems for devices are designed. However, there are some nuances that will require additional testing and some subtleties when validating a final package system as described in Clause 6. There are also other areas of relief from testing such as using previously documented studies for stability testing and documented evidence of previous evaluations for material compatibility.
Patrick Nolan is Chief Operating Officer of DDL Inc, 10200 Valley View Road, Suite 101, Eden Prairie, Minnesota 55344, USA, tel. +1 952 941 9226, e-mail: pat.nolan@testedandproven.com, www.testedandproven.com
