France's AES Laboratories has developed a system for the rapid monitoring of air in the cleanroom or pharmaceutical production facility for microbial contamination, without having to wait days for culturing, reports Phil Taylor.
The system, developed by AES and its subsidiary Chemunex, makes use of AES' Samplair, a portable air monitoring system that uses standard Petri dishes (pictured), and a solid-phase cytometer supplied by Chemunex. It can provide a measurement within as little as three hours.
The microbiological control of clean rooms and controlled environments has become a key element of the quality assurance program of pharmaceutical production sites. Traditionally, these controls are based on the collection of microorganisms onto a media plate followed by incubation over several days. After the growth period, the contamination level is determined by counting the visible colonies on the plate.
This method is simple but has the disadvantage of providing results 3 to 5 days after the sample collection, meaning that real time corrective action is not possible. Moreover, the traditional method does not enumerate all microorganisms present in the air, because"stressed" or slow growing microorganisms require longer recovery times.
AES and Chemunex' solution is to use the Samplair to sample the air in the cleanroom, which will draw in any microorganisms present and deposit them on a Petri dish. The dish is filled with a special gel - called Polymair - that does not contain any nutrients and serves only to hold the trapped organisms in place. After sampling, a fluid is added that dissolves the polymer, which is then filtered to concentrate particules - including microorganisms - that are present.
Chemunex' ChemScan RDI laser scanning cytometer is then used to detect microorganisms in the resulting sample using proven techniques that are already widely used in the pharmaceutical industry for the analysis of process water.