Packaging Validation - Sterile Barrier Systems ISO 11607

Companies in the life science sector must comply with standards and regulations that include validation requirements.

Validation projects often take longer than expected.  The reasons for these delays can be;

·     Protocol and report writing and approvals

·     Managing unforeseen changes

·     Addressing deviations

·     Compiling all the evidence.

Validation reports should remain in an audit-ready state.  Startups and SMEs may not have a Validation Engineer, and it can be helpful to have intermittent support. My background in validation, quality management and statistical knowledge is advantageous in this area.

Validation of Sterile Packaging - ISO 11607-1 and ISO 11607-2

ISO 11607 was updated in 2019 in an effort to harmonise the standard with the new EU MDR, and further updates are being discussed.  My background in sterile barrier solutions enables me to support clients with their sterile packaging validations.  The FDA lists ISO 11607-1 and ISO 11607-2 as recognised consensus standards for medical devices.

ISO 11607-1 covers the requirements and methods for testing the sterile barrier systems and packaging systems required to keep terminally sterilised medical devices sterile until the point of use. 

ISO 11607-2 covers the requirements for validation of processes by manufacturers to ensure the sterile barrier systems for the medical devices work as intended and keep devices sterilised until their use.

ISO 13485:2016 section 7.5.7 already details requirements to validate processes for sterilisation and sterile barrier systems and refers to ISO 11607-1 and ISO 11607-2

Processes for sterilization and sterile barrier systems shall be validated prior to implementation and following product or process changes, as appropriate. Records of the results and, conclusion of validation and necessary actions from the validation shall be maintained. NOTE Further information can be found in ISO 11607-1 and ISO 11607-2.

I supported a medical device manufacturer over an eight month period with their sterile packaging validation against the requirements of ISO 11607-1 and ISO 11607-2 as part of their EU MDR remediation project; this included stability testing.  Stability testing is an area that is often overlooked.