Modern medicine is predicated on the safety provided by sterility assurance and aseptic practices. The United States Pharmacopeia defines these two important concepts. “Sterile means having a complete absence of viable
microorganisms or organisms that have the potential to reproduce.” “Aseptic describes the process for handling
sterilised materials in a controlled environment designed to maintain microbial contamination at levels known to
present minimal risk” (USP <1116>). From these two concepts arises the quality control regulations and practices
that guide the medical and pharmaceutical world today.

From these principles, the manufacturing of sterile products requires many aseptic techniques and tests to
assure sterility. These include adequate facilities that are cleaned of particles, regular environmental monitoring and bioburden testing of the raw materials coming in. These procedures all lead to the final product, which will be tested according to the sterility test.

Traditional Sterility Testing Methods
The sterility test is a simple and accurate test that has remained consistent since being adopted by the British Pharmacopoeia in 1932. It has since been accepted globally and harmonised. Examples of its requirements can be found in USP <71>, European Pharmacopoeia (Ph. Eur.) 2.6.1 and ICH Q4B Annex 8. The test involves an inoculation of the sample in a growth media and then incubation for 14 days. The media is then visually inspected for growth. A negative test indicates that the sample tested is free of viable microorganisms.