Quality-control analytical methods: the quality of sterility testing

Microbiology, like compounding, is a science that must be demonstrated to show that it is reliable, reproducible, and scientifically sound. Aseptic technique must become second nature to the microbiologist and the compounding pharmacist. With each new drug tested by a quality-control laboratory, there is a responsibility that everything possible is done to ensure that the test result reported is accurate and reliable. While it is recognized that the conventional sterility-testing method has inherent deficiencies, an alternative method cannot be used unless it provides equivalent asurance of detecting microbial contamination. A quality-control laboratory and compounding pharmacists should adhere to the standards of the United States Pharmacopeia when compounding and testing preparations.