Pharmaceutical package testing can be regarded as a two part process. Package testing system should include package integrity (leak) testing and seal strength testing, two complementary but very different procedures. Both testing modes are important for final package analysis. The tm electronics bt-1000 automated package tester provides seal strength and package integrity testing in one instrument, and also provides the documentation necessary for the packaging process validation and control. In order to produce acceptable packaging on a daily basis and throughout a determined shelf life validation, it is important to evaluate the strength characteristic. The microbial barrier properties of the package materials and design must be evaluated after exposure to the environmental and dynamic stresses expected for the finished package. Several methods may be used to satisfy these requirements. They involve evaluating the material performance itself and the whole, finished package as produced on the packaging line. In order to maintain the sterility of a packaged product until it reaches its point of end use, the package must have a microbial barrier in its post-sterilization environment. The manufacturer must demonstrate that, under the rigors of distribution, storage, handling, and aging, the sterile package integrity is maintained at least for the claimed shelf life of the medical device or product.