The International Cleanroom Standards (ISO 14644-1 & 2) have been updated, these changes affect the requirements for the classification testing and monitoring of ALL cleanrooms. The classification testing standard has significant changes and includes the requirements for the development of a “Monitoring Plan” based upon risk assessment. How will you comply with these changes?
With changes to number of sampling sites, testing frequencies, particle classification limits and rules it is critical to re-visit your environmental monitoring program.
How will you address the differences between particulate limits for classification and monitoring as changed in the new ISO 14644 parts 1 & 2 and those of current EU Ennex1?
A risk based approach to environmental monitoring is emphasized in the new ISO standard and the current EU Annex 1. As the ISO standards are being updated, PICs supported by EMA is in the process of revising EU Annex 1 to align with ICH Q9 and Q10 risk based approach and current technologies. A risk based approach to sample site selection, considerations for monitoring technology, as well as other risk considerations during environmental monitoring will be discussed in this two day intensive training.