Pharmaceutical Microbiology EC — SMi’s 5th Annual Pharmaceutical Microbiology East Coast Conference

Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches. Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex 1, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.

Topics: Pharmaceutical Microbiology, Microbiology, Pharmaceuticals, Aseptic Technique, Sterility, Bioburden, Mycoplasma, Quality Control, Rapid Microbial Methods, Data Integrity, Risk Assessments, Environmental Monitoring, EM, Contamination Control Strategy, data integrity, microbiome, Endotoxin, US Pharmacopeia, Annex 1, Contamination Control