Avoiding Common Errors During Viable Microbial Contamination Investigations
Pharmaceutical companies are required by regulatory authorities to conduct thorough investigations into microbial contamination events related to aseptic manufacturing of sterile products. Often a variety of errors are made during the course of such investigations. In many cases, those are errors in judgment which preclude finding the Root Cause of the problem and prevent identification of a long-term solution. The major goals of such an investigation are to locate the source of the contaminating microorganism and then to determine the Root Cause, i.e., how that microbial contaminant got into the “sterile” product or aseptic processing area. Often wrong assumptions are made based upon previous experience or lack of sufficient technical knowledge. Extraordinary Environmental Monitoring (EM) is typically required to locate the source(s) of the microbial contamination. Examples of errors in judgment (Wrong Thinking) and case studies are provided to aid the reader in conducting the best possible sterility assurance failure investigations.
KeywordsHydrogen Peroxide Filtration Agar DMSO Steam
- U.S. Department of Health and Human Services, Food & Drug Administration, September 2004, Guidance for industry: Sterile drug products produced by aseptic processing—current good manufacturing practice. U.S. FDA, Silver SpringGoogle Scholar
- USP (2013) Chapter <1116> Microbiological control and monitoring of aseptic processing environments. The United States Pharmacopeial Convention, Rockville, p 707Google Scholar