Updated guidance on packaging for terminally-sterilized devices

Guidance on the application of the BS EN ISO 11607 series of standards being balloted

Sterile barrier systems are intended to ensure the sterility of their contents until opened for use. They are also designed to permit aseptic presentation of their contents. The sterile barrier system provides protection for the sterile medical device but its ability to do so depends on how it is handled and stored. When the packaged and sterilized device undergoes repeated handling, additional protective packaging may need to be combined with the sterile barrier system to create an overall packaging system.

The BS EN ISO 11607 series of standards specifies requirements for sterile barrier systems:

• ISO 11607-1 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging -  includes  the validation of the packaging system design;
• ISO 11607-2 - Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes - covers packaging process validation.

The scopes of these standards applies wherever medical devices are packaged and sterilized. Therefore, they can be applicable to  medical device manufacturer, a health care facility, or an organization that reprocesses medical devices.

BS EN ISO 11607-1 and -2 were revised in 2019. Both standards give requirements covering medical device protection, the ability to sterilize, maintenance of sterile package integrity and aseptic presentation. The main changes were:

• new requirements for the evaluation of usability for aseptic presentation;
• a new section on revalidation;
• updated Annex on test methods with methods being added or deleted;
• a new Annex with environmental considerations;
• a new Annex with guidance on ways to differentiate a sterile barrier system from protective packaging.

ISO/TS 16775:2014 provided guidance on the previous editions of BS EN ISO 11607 -1 and -2. A new edition of ISO/TS 16775 - Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 - has been prepared to support the new editions. The main changes compared to the previous edition are:

• updates to reflect changes to ISO 11607-1 and ISO 11607-2;
• guidance being given for each clause of the standard to improve usability of this document.
• the addition of new Annexes;
• the restructuring, combination or removal of some Annexes.

As a result, the guidance address EN ISO 11607-1 and -2 clause by clause. In addition there are 14 annexes providing further guidance on specific topics. The revised Annexes are:

• Annex B - Guidance on the application of ISO 11607 in health care facilities;
• Annex C - Risk analysis tools — Guidance for industry and health care facilities; 
• Annex D - Considerations for sampling plans – Guidance for health care facilities;
• Annex E - Guidance on establishing process parameters – Guidance for industry;
• Annex J - Validation summary – Guidance for health care facilities;
• Annex M - Validation for heat sealing process for preformed sterile barrier systems– Guidance for health care facilities.

And the new Annexes are:

• Annex A - Design and development for packaging systems – Guidance for industry;
• Annex F - Sterilization considerations – Guidance for industry and health care facilities;
• Annex G - Use of contract packagers – Guidance for industry and health care facilities;
• Annex H - Example of a handling, distribution and storage checklist – Guidance for health care facilities for selecting a sterile barrier system;
• Annex I - Investigating failure – Guidance for industry and health care facilities;
• Annex K - Validation for wrapping process — Guidance for health care facilities;
• Annex L - Validation for container process – Guidance for health care facilities;
• Annex N - Evaluation of sterile packaging by end users – Guidance for healthcare facilities.

The revised guidance is currently being circulated in national committees for review and ballot until the end of July 2020. Now is an opportunity for users of the ISO 11607 series of standards to become familiar with the new guidance. The Medical Devices Regulation has an increased focus on sterile barrier systems for sterile devices. Therefore, manufacturers of sterile devices, health care facilities performing sterilization and reprocessors that resterilize devices will all have an interest in this updated guidance.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development