ISO 14644-2-2015 pdf free.Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
This part of Iso 14644 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.
This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. it does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 pm to 5 pm. Concentrations of ultrafine particles (particles smaller than 0,lpm) will be addressed in a separate standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14644-1 and the following apply:
3.1 test procedure undertaken in accordance with a defined method to determine the performance of an installation or an element thereof
3.2 monitoring observations made by measurement in accordance with a defined method and plan to provide evidence of the performance of an installation
Note 1 to entry: Monitoring may be continuous, sequential or periodic; and if periodic, the frequency shall be specified.
Note 2 to entry: This information may be used to detect trends in operational state and to provide process support.
3.3 action level level of a parameter set by the user which, when exceeded, requires immediate intervention, including investigat ion of cause, and corrective action.
4 Creating, implementing and maintaining a monitoring plan
4.1 Principle
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.
4.2 Risk assessment
Risk assessment is a systematic process of identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.ISO 14644-2 pdf free download.