Validation Sterile barrier

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 computer software used in the QMS

Medical Device Startups are juggling the pressure of designing products alongside the development of a quality management system.  I have noted that validation of computer software used in the Quality Management System is a requirement often forgotten about.  This requirement is included in both ISO 13485:2016 and 21 CFR Part 820.70.  See references below.  This includes software applications used for the design and development of products, complaint handling, CAPA, calibration, maintenance, doc control, testing, labelling, stock control and any other applications used in the quality Management System. If you require validation support, I can advise how to categorise by software type, intended use and level of risk and in turn it is possible to determine the level of verification and validation required.


ISO 13485 was updated in 2016 and includes a new requirement in Section 4.1.6 The organisation shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and as appropriate, after changes to such software or its application. The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. Records of such activities shall be maintained (see 4.2.5).

21 CFR 820.70 (i) Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.


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.


Between 2021 and 2022, 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.