Our last blog on this topic discussed the technological advances that have changed sterility assurance. Today we address rapid microbiology methods and the impact on sterility assurance.
Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities, where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a cGMP-manufacturing environment. The nonviable particulate monitoring program plays an important role as it is used on a routine basis to verify the maintenance of air classifications.
It would be good to have instrumentation capable to detecting more diverse types of microbial contaminants (including damaged, stressed, dormant, and VBNC cells) that usually do not grow on the media described in the guidelines but could potentially grow as an opportunistic infection under special conditions found in clinical patients.
The pharmaceutical industry has been called upon to continually raise its sterility assurance standards through ongoing increased global regulatory standards, especially over the last ten years. Various regulatory agencies expect faster and more complete microbial contamination control. In response to this expectation, suppliers have found a variety of approaches and solutions to meet these needs in a way that both satisfies regulatory requirements and helps pharmaceuticals save time and money by efficiently and accurately providing effective air and surface microbial monitoring. Top solutions for pharmaceutical contamination control meet at least one of the following criteria: sterility requirements, automation, and single use.
Learn more now by downloading the full paper, Advances in Sterility Assurance: Single Use Devices and Rapid Microbiological Tests.