CONTINUOUS MICROBIAL MONITORING IN CLEANROOM
The aseptic filling lines, in Grade A where pharmaceutical products are not terminally sterilized, should be under strict control for their safety. It is requested a method which continuously surveys all production process and with sampling at multiple points. These environments are required to have ZERO CFU/cubic meter of air.
Annex1 – EU GMP Guide request to sample at least 1 cubic meter of air (1.000 l).
When the working shift is over 2 hours, the implementation of continuous air monitoring with two or three aspirating heads samplers is necessary to cover the total production process with more sampling points.
The sampling protocol is performed with continuous direct or fractioned aspiration.
Another important consideration is that with the pluri-heads samplers, the human intervention is reduced to avoid the risk of secondary contamination.
ORUM International gives different options to apply the “continuous microbial monitoring”.