It is widely recognized that the current growth-based sterility tests with an incubation period of at least 14 days (see Sterility Tests 〈71〉) are not suitable for products with a short shelf-life or for products prepared for immediate use, which are usually infused into patients before the completion of the test (1). These short-life products include compounded sterile preparations (CSPs), positron emission tomographic (PET) products, and cell and gene therapies, which require a new generation of risk-based approaches that include rapid microbial tests. For a general discussion of the factors other than sterility testing that contribute to sterility assurance, see Sterility Assurance 〈1211〉. It should be noted that as with alternate test methods, the referee test in the event of a dispute is 〈71〉.