Validate Your Medical Device Packaging

To ensure the safety of medical device products, ISO 11607 establishes critical requirements for packaging sterility, usability, and durability. ISO 11607 has two parts for healthcare packaging validation. Part 1 sets requirements for materials, sterile barrier systems, and packaging systems. Part 2 is the validation requirement for forming, sealing, and assembly processes.

One of the most critical requirements of ISO 11607 is that the packaging must maintain sterility until the device is used. This means every scenario, from the time the product leaves the manufacturing floor to the moment it is unsealed by medical professionals, must be considered during the testing process. As a result, manufacturers must validate packaging processes using rigorous testing to confirm package integrity and strength. The materials and design of the packaging must withstand the sterilization process without degradation or defects. Additionally, the packaging system should offer robust protection against microbial contamination and endure the stresses of handling and transportation. To support usability, packaging must include clear instructions for healthcare professionals to open the sterile barrier system aseptically and labels should indicate where to begin opening to prevent contamination or damage. 

Healthcare packaging validation is not legally mandated by the FDA, but this doesn’t mean it isn’t critical to the success and safety of your medical device. Not following such standard safety and sterility procedures could expose your company to potential lawsuits, recalls, or financial losses.