On-line leak testing is commonly in

On-line leak testing is commonly integrated into a continuous fill and seal product–package manufacturing process. A prerequisite for an on-line leak test method for entire lot testing is that it be nondestructive to the package and its contents. Online testing can potentially provide greater assurance that all packages have integrity and can yield instant feedback in the event of package misassembly or breakage, enabling real-time line corrections. For some test systems, incorporating largescale leak detection equipment into a complex high-speed product–package filling and assembly line can be prohibitive. Higher line speeds leading to shorter leak detection test cycle times can limit test method detection capability. In addition, the impact of instrument downtime on the production run as a result of leaking packages or possible equipment malfunction is an important consideration. A separate leak testing line may be set up outside the sterile manufacturing suite to allow for full lot testing without the complications of leak test integration with package filling/sealing operations. A few examples of on-line leak test technologies include electrical conductivity and capacitance, vacuum decay leak, and noninvasive laser-based gas headspace analysis tests.