Standards Release: ISO 11607-3:2026 Puts Heat Sealing Process Development in Focus
A new part of the medical device packaging standard gives manufacturers a clearer path from sterile barrier requirements to a process ready for validation.
A strong seal starts well before process validation. It starts with understanding what the sterile barrier system must do, identifying what can go wrong, and developing a heat sealing process that can consistently meet those requirements.
Published in September 2026, ISO 11607-3 addresses that critical development work. The new standard covers process development to establish heat sealing parameters that satisfy regulatory requirements for sterile barrier systems (SBS) . The standard requires users to be competent in executing a good design of experiment (DOE) and access to the appropriate testing resource. If you have a good DOE but are lacking the required equipment to execute it, WESTPAK; can help.
What does Part 3 add?
The ISO 11607 series already addresses sterile barrier materials and packaging systems in Part 1, and process specification and validation in Part 2. Part 3 focuses on SBS seals and is used before process validation, developing the process from the sterile barrier system specification and guided by risk management.
For packaging teams, that means a closer look at how they:
- Translate sterile barrier requirements into a heat sealing process specification.
- Identify critical process variables and risks that could affect seal quality.
- Plan how the process will be controlled and monitored.
- Select equipment features that support consistent sealing, validation, and ongoing monitoring.
- Document when heat sealing processes can be considered equivalent across equipment or packaging families.
The standard also includes guidance on establishing process parameters, heat sealing fundamentals, equipment features, and evaluating process equivalence. These topics can be especially relevant when adding a sealer, transferring production, or changing a packaging material.
What should manufacturers do now?
Start with a gap review of your current heat sealing development records. Can your team trace the sterile barrier system requirements through process development, risk analysis, test results, and the controls used in production? If you use multiple sealers or sites, what evidence supports any claim that their processes produce equivalent results?
An existing validated process does not automatically need to be repeated because Part 3 has been published. The right action depends on your products, process history, applicable requirements, and the quality of your existing evidence. A focused review can show where documentation is already strong and where additional testing or development work may help.
How Can WESTPAK Help with ISO 11607-3:2026 Compliance?
WESTPAK helps medical device teams plan and perform package testing, including seal strength, package integrity, aging, and distribution testing. We can discuss your sterile barrier system, review the testing evidence behind your process development and validation strategy, and help identify practical next steps for your packaging program.
Have questions about ISO 11607-3:2026? Contact WESTPAK to discuss how the new standard may affect your heat sealing process and testing plan.