Container–closure integrity tests h

Container–closure integrity tests have been recommended as alternatives to sterility testing as part of commercial product stability programs. The goal is to ensure package integrity as a function of long-term product storage (1). [NOTE—Package integrity tests do not replace product release sterility is a poor measure of product–package integrity and also will not ensure product–package integrity over the shelf life of the product when performed as part of the stability program. In addition, a package may be in no danger of microbial ingress and yet be unable to maintain the gas headspace content necessary for product quality. Validated package integrity test methods using technologies such as those described in this chapter are more sensitive and reliable than product lot sterility testing for detecting a breach in package integrity that could lead to sterility loss loss or failure in relevant product physicochemical quality attributes.