ISO 14644:2015 pdf free
ISO 14644:2015 pdf free.Cleanrooms and associated controlled environments
In order to gain assurance that a cleanroom or clean zone is performing adequately by delivering the required control of air cleanliness by particle concentration, a monitoring plan shall be created,implemented and maintained.
A monitoring plan shall take into account the level of air cleanliness required, critical locations and performance attributes of the cleanroom or clean zone that affect the performance of the installation. The following steps shall be included in the creation, implementation and maintenance of the monitoring plan:
– use appropriate risk assessment tools to understand, evaluate and document the risk of adverse contamination events;
– develop a written monitoring plan;
– review and approve the plan;
– implement the plan by performing the monitoring;
– analyse the data derived from the monitoring activity, undertake trend analysis where appropriate and report performance;
-implement and document actions or corrective actions required;
– undertake periodic review of the monitoring plan.
The concentration of airborne particles measured under a monitoring plan may be higher than the concentration observed during at-rest classification. The observed values may fluctuate considerably due to factors such as, but not limited to, the number of personnel present, the airflow rate, ventilation effectiveness, the operation of instruments or machinery, and activities in adjacent spaces.
For processes that inherently produce particles as part of the process and where these particles are not a threat to the process or product, it may be appropriate to rely on periodic at-rest classification,or operational classification of simulated operations, rather than monitoring of airborne particles in operation. Other performance and cleanliness attributes may still be required to be monitored.
ldentification and justification of selected monitoring locations. Monitoring locations shall be defined in three dimensions.
Identification and justification of monitoring acceptance criteria or limits, including establishment of a single alarm level, or a dual alarm approach of alert and action levels. The minimum requirement is that a single alarm action level is established. Additionally, an alarm alert level can be established to provide early warning of performance deviation. For further guidance on setting alert and action levels, see informative Annex B.ISO 14644 pdf download.
