INTRODUCTION

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 due to clinical needs before completion of the sterility test (1). These products may include (list is not exhaustive) compounded sterile preparations (CSPs), nuclear medicine products, and Advanced Therapy Medicinal Products (ATMPs). For a general discussion on the factors (other than sterility testing) that contribute to sterility assurance, see Sterility Assurance 〈1211〉. If a microbiological test is conducted, patient safety is best served through the completion of a test that detects microbial contamination prior to product use.