PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Topics Review
Validation of a new air sampler for rapid environmental monitoring
Ms Quitterie Brossard-Desjonquères
Author information
JOURNAL FREE ACCESS

2010 Volume 12 Issue 1 Pages 8-12

Details
Abstract

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.

Content from these authors
© 2010 Parenteral Drug Association Japan Chapter
Previous article Next article
feedback
Top