Sterilization and Packaging Development: The Chicken and Egg Dilemma

Sterilization modalities and medical device packaging are deeply interdependent decisions that should be evaluated together from the earliest stages of product development. This white paper examines how ethylene oxide and radiation sterilization processes can influence sterile barrier system performance, while also showing how packaging design can affect sterilization efficacy and process robustness. By addressing sterilization and packaging as connected design inputs rather than sequential afterthoughts, manufacturers can reduce technical, regulatory, commercialization risks and costs.