Can’t I just get a package that is already validated?
You may be able to get close to that if you have other very similar products. You can use a product family validation and that would make life relatively simple. You really can’t get a package that is fully pre-validated because it’s not just the package that is being validated. It is a package and product combination and that combination is designed for a specific sterilization procedure, a specific set of distribution requirements and so it’s really all those requirements together that make the total validation.