[in Japanese]

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Microbial contamination control of air in cleanroom environment has been playing an increasingly important part for pharmaceutical, food and cosmetic industries as well as healthcare establishments. ISO 14698 norm describes the microbiological controls methods in cleanrooms and especially those concerning the airborne contamination control. These precautions are necessary to ensure good quality products and safe working conditions. In its last version (2004), the ISO 14698 norm presents two different types of collection methods: the passive sampling equipment (settle plates) and the active one. However, these methods are limited to cultivable flora (CFU/m³) and require a long time-to-results. Over the last 15 years, the emergence of Rapid Microbiological Methods (RMM) has tackled those limitations by producing more sensitive and more complete results in real-time and made cleanrooms management less time-consuming and more cost-saving. These RMM are now compatible with airborne contamination controls thanks to the development of a cyclonic air sampling technology Coriolis^® delivering a liquid sample. This method has been validated according to ISO 14698.1 by Health Protection Agency (UK), and considered to be suitable for routine controls of cleanrooms.

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  Recent agreements between the US FDA and its European Union counterparts to cooperate on pharmaceutical plant inspections to enable stepped up enforcement of safety guidelines require every pharmaceutical manufacturer to be on higher alert to maintain a best-practice focus on quality systems. These agreements will help regulators be more efficient with their resources. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Revisiting cost-vs.-benefit analyses for continuous monitoring modalities (wired or wireless networks and standalone monitoring instruments) that facilitate the ability to comply with auditors' requests for proof of regulatory compliance is very timely. Moreover, the ever increasing costs for APIs and the R&D efforts to create them are such that the economic costs of failure in the totality of monitoring systems are greater than ever before. All monitoring methods whether wired, wireless or standalone instrumentation need to be scrutinized for systemic weaknesses that allow human error to compromise product quality, system failure probabilities and overall costs of ownership. This white paper discusses five approaches to monitoring critical environments such as pharmaceutical freezers, stability rooms and warehouses. Quality, facility and IT managers employ different methods for maintaining the quality products and information. This paper evaluates each the different methods and presents the risks and cost of ownership for each type.

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