Microbiology

As part of a Contamination Control Strategy (CCS) for Environmental Monitoring of Grade A areas for the presence of viable organisms, PMT now have a number of options available for our clients. Based on traditional growth based methods, employing agar plates, we offer a range of Active Air Samplers which can be used either as stand-alone instruments or remotely as part of a system. Different sampling methodologies of slit-to-agar or sieve impaction can sample 1 cubic metre of air rapidly or over an entire production run with minimal plate changes. Dedicated Compressed Gas Samplers are also available. Real-Time Biofluorescent Particle Counters (BFPC’s), based on Laser Induced Fluorescence (LIF), permit continuous microbial monitoring of Grade A manufacturing areas, accurate down to a single cell. This allows the user to “see now and react now” if a contamination event occurs, saving precious time and risk to the product. Root Cause Analysis in beep mode (like a “microbial Geiger Counter) or for bioburden monitoring of locations under investigation are other uses for BFPC’s.
 

The New Annex 1

With the publication of the updated version of the EU GMP Annex I (Manufacture of Sterile Medicinal Products), several relevant changes regarding continuous microbiological monitoring of sterile manufacturing processes in the pharmaceutical industry are now forthcoming. These changes focus, among other things, on monitoring in Grade A areas and now provide for continuous monitoring of all process steps. We would be happy to advise you on the upcoming changes as well as solutions to adapt your processes.