It is clear that what is intended for use in critical environments should be produced under at least equally controlled environmental conditions. For this reason, Merck Millipore fully validates its microbial and particle air monitoring instruments for all relevant markets the world over and, for its culture media disposables, performs studies to support the in-house validation that end-users need to conduct. While data on parameters such as temperature, relative humidity or air pressure differentials is relatively easy to collect, analyse and store using a computer- controlled cleanroom monitoring system, microbiological monitoring must be conducted separately because, due to its more complex nature, it cannot be sensibly integrated.Ī key concern of decision-makers in pharmaceutical companies is that the instruments and disposables they purchase are validated according to established standards, in particular those of the FDA. The routines need to be as straightforward and fail-safe as possible to yield reliable results every time. In the worst case scenario products must be recalled, with reputational damage likely to follow. Contamination in cleanrooms or isolators can not only lead to the loss of an entire product batch but may also result in further time needed for corrective action to resolve the problem. Microbial monitoring of ambient air, surfaces and personnel in critical areas is a significant risk and cost issue in pharmaceutical production. Anne-Grit Klees and Tony Ancrum, Merck Millipore, discuss key points. Microbiological monitoring in critical areas requires a good understanding of the main properties of monitoring disposables. For testing irregular surfaces such as equipment recesses, nooks, crevices, tubing and filling needles, where contact plates are impractical, pre-moistened swabs may be used to validate cleaning and sanitation procedures and to verify that a required hygiene level has been reached. Disposables, such as settle plates, contact plates and swabs, should thus be filled in cleanrooms that meet high microbiological standards. Routines for microbial monitoring of ambient air, surfaces and personnel in critical areas need to be as straightforward and fail-safe as possible to yield reliable results.

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