The authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined. Sterility assurance is critically ...

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures ...

Guidelines on Reducing the Time Needed to Accurately Conduct a Bubble Point Test Integrity testing filters post-use is a regulatory requirement for products labeled sterile. The bubble point (BP) test ...