BS EN ISO 14644-2:2015,Cleanrooms And Associated Controlled Environments – Part2:Monitoring To Provide Evidence Of Cleanroom Performance Related To Air Cleanliness By Particle Concentration (British Standard)
This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with ISO 14644-1: 2015, 5.1. The monitoring activity provides a continuing flow of data over time, thereby providing a more detailed view of the performance of the installation.
ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
In some circumstances, relevant regulatory agencies may impose supplementary policies, requirements or restrictions. In such situations, appropriate adaptations of the monitoring procedures may be required. After a monitoring plan is initially established and implemented, it may be necessary to revise the plan when significant changes are made to the installation or process requirements. It is also prudent to conduct periodic reviews of a monitoring plan based on data obtained and experience in use.
In order to gain assurance that a cleanroom or clean zone is performing adequately by deliveringthe required control of air cleanliness by particle concentration, a monitoring plan shall be created,implemented and maintained.