What to Expect with ISO 11607-3

Introduction

The ISO 11607 series has long been the consensus standard for terminally sterilized medical device packaging, providing significant value for medical device manufacturers, sterile packaging manufacturers, healthcare systems and regulators since it was initially published in 1997. In 2006, the standard was revised into two documents to provide better and deeper clarity into package design and process validation. ISO 11607-1 contains consensus requirements for sterile barrier design, materials, performance, stability and usability while ISO 11607-2 covers the requirements for process validation and controls. Now in 2025, further expansion of the ISO 11607 series is underway.

Why

When considering the process of building a reliable sterile barrier system, the closing of the package is a critical process. In order to ensure a commiserate level of technical rigor, a robust process development activity should be performed during the validation of the heat sealing process. ISO 11607-2 requires process development and there is a guidance in the informative Annex A on the aspects of process development. There is additional guidance on process development in ISO TS 16775. However, there is a lack of a consensus standard to support this specific (and critical) part of forming a sterile barrier system.

Further, it is commonplace for manufacturers to transfer operations, expand operations, or retire and replace sealing equipment. A consensus method for documenting the equivalence of a sealing process across one or more machines can lead to efficiencies in resource optimization when expanding or evolving operations.

This is the ground that the new work item for ISO 11607-3 seeks to cover.

What/Scope

ISO 11607-3 is aimed at industrial manufacturers engaged in the design and development of sterile barrier systems and heat sealing processes, such as medical device manufacturers and sterile packaging manufacturers. Consensus process development activities can provide value to these groups that are developing and running heat sealing equipment across a wide range of manufacturing operations. Additionally, ISO 11607-3 consensus content for demonstrating equivalency of heat sealing processes would provide value for companies to optimize resources, and better leverage previous testing.

While ISO 11607-3 seeks to create a rigorous consensus standard around process development and process equivalence for heat sealing, it is acknowledged that it will not be the only scientifically acceptable approach to either topic. The standard will be available to those that seek to benefit from it, however, it is intended to remain a completely voluntary standard.

What happens next

The development of ISO 11607-3 is following the 3 year ISO standard development process. Currently the document is in the committee stage. During committee stage an initial draft is created and a ballot is circulated to mirror group committees from each of the participating countries, who then have the opportunity to provide comments on the document content to the ISO working group. The ISO working group will then need to resolve all of the comments received. The ISO 11607-3 committee draft ballot has been completed and the resolution of the comments is in process. Should the comments be resolved, it could become a Draft International Standard, or DIS, early this summer and will be on track to be published as a standard in 2026.