The requirements for validating the back-end processes for packaging, manufacturing, sterilization and shelf life of a sterile medical device are often misunderstood. Errors and oversights can result in failed validation tests and longer-term sterile barrier reliability.
It can take nearly a year to get a validated sterile package to market, and many medical device manufacturers fail to plan for this time and expense. While regulations govern package design and validation, manufacturers must also coordinate compliance with additional regulations for manufacturing, sterilization, and shelf-life validation to reduce lead time, improve quality and reduce costs. Here’s an explanation of how to coordinate these validation requirements to get single-use medical devices to market faster and less expensively.