Investigation on the Risk of Contaminating Mircobe in Sterile Preparations of Biologics and the Culture Conditions of Sterility Test

OBJECTIVE To investigate the necessity of retaining special culture conditions for biologics in the sterility test of Chinese Pharmacopoei. METHODS To carry out a 2-year investigation on the species and frequency of contaminated microbes captured in products and high-grade clean areas of biologics manufacturers nationwide, and verify the culture conditions of contaminated microbes. RESULTS There was no need to adopt fluid thioglycollate medium for low temperature (20-25℃) culture of contaminated microbes reported by manufacturers with definite identification results. CONCLUSION From the perspective of culture spectrum, it is suggested to revise the requirements of special culture conditions for biologics in the sterility test of Chinese Pharmacopoeia based on risk assessment.