INTERNATIONAL STANDARD
environments- Cleanroomsandassociatedcontrolled
Part 2: Monitoringtoprovideevidenceof cleanroomperformancerelatedtoair cleanlinessbyparticleconcentration
Salles propres et environnements maitrises apparentes - Partie 2: Surveillonce du maintien des performances de la salle proprepour la proprete particulaire de Iair
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ISO 2015 Published in Switzerland
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Contents
Foreword ivIntroduction.2 1 adoos Normative references. 13 Terms and definitions. 1 14 Creating implementing and maintaining a monitoring plan. 24.1 4.2 Risk assessment. Principle. 2 24.3 4.4 Monitoring plan.. Calibration. 3 34.6 4.5 Review and approval Response to a deviation during monitoring 4 45 Periodic classification of air cleanliness by particle concentration 4Annex A (informative) Matters to consider when developing a monitoring plan. 5Bibliography. Annex B (informative) Considerations for setting alert and action levels. 14 9
ISO 14644-2:2015(E)
Foreword
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The mittee responsible for this document is ISO/TC 209 Cleanrooms and associated controlled environments.
This second edition cancels and replaces the first edition (ISO 14644-2:2000) which has beentechnically revised throughout.
ISO 14644 consists of the following parts under the general title Cleonrooms and associated controlled
-Part 1: Classification of air cleanliness by particle concentrationPart 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particleconcentration--Part 7: Separative devices (clean air hoods gloveboxes isolators and mini-environments)Pairt 8: Classification of air cleanliness by chemical concentration (ACC)-Part 9: Classificotion of surface cleanliness by particle concentration
-Part 3: Test methods
Part 4: Design construction and start-up
-Part 5: Operations
-Part 10: Classification of surface cleanliness by chemical concentration
Attention is also drawn to ISO 14698 Cleanrooms and associated controlled environments -Bio-contamination control:
- Part 1: General principles and methods-Part 2: Evoluation and interpretation of bio-contamination data
Introduction
This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition tothe 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 therebyproviding a more detailed view of the performance of the installation.
Potential benefits gained from monitoring are
- faster response to adverse events and conditions -- integration of data from multiple instruments - ability to develop trends from data over time enhanced knowledge of installation and process which allows for more effective risk assessment and- improved control of operational costs and product losses.
ISO 14644-2 specifies the requirements of a monitoring plan based on risk assessment of the intendeduse. The data obtained provide evidence of cleanroom or clean zone performance related to air cleanliness by particle concentration.
In some circumstances relevant regulatoryagenciesmayimpose supplementarypolicies requirementsrequired. After a monitoring plan is initially established and implemented it may be necessary to or restrictions. In such situations appropriate adaptations of the monitoring procedures may berevise 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.
