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 sterilisation 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.
Seamus Kelly, Regulatory Manager at ATD emolda "I highly recommend Anne Marie for any validation roles you may require around medical device sterile barriers. I contacted Anne Marie to support our revalidations of SBS over 2 years at B Braun in Sligo.
Anne Marie possesses a deep knowledge and ability to execute the material section as required by ISO 11607-1 and the engineering validation needed for ISO 11607-2. She seamlessly adapted to our different sealing machinery platforms and delivered the IQ/OQ/PQ Executions with final report development to leave the company in a solid audit ready and compliant state for NSAI audits.
As a contractor, Anne Marie integrated effortlessly with our cross-functional teams and required zero hand-holding. She is a dedicated compliance expert who consistently challenged us and assisted us through meticulous work. She will be an immediate asset to any organization".
Andrea Lally, Senior R&D Chemist "It was a pleasure to work with Anne Marie on packaging validations to ISO 11607. Her knowledge, professionalism and attention to detail were evident throughout all stages of the project ensuring a high standard of work and regulatory compliance".
Gary Dillon Managing Director at Dillon Engineering Services "I’ve worked with Anne Marie throughout 2021 through her company Limehill Quality Solutions and she has done a great job. Anne Marie was on assignment with a global medical device company based in the west of Ireland. She supported the medical device client in the area of packaging validation as part of their MDR remediation project. Her attention to detail and client interactions were highly appreciated by the client. I would highly recommend Ann Marie for any quality related assignment and look forward to working with her again in the future."