2010 Volume 12 Issue 1 Pages 8-12
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.