Standard
Track updates
AS ISO 14644.2:2017
[Current]Cleanrooms and associated controlled environments, Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
Adopts ISO 14644-2:2015 to specify 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.
Published: 13/12/2017
Pages: 14
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Creating, implementing and maintaining a monitoring plan
4.1 Principle
4.2 Risk assessment
4.3 Monitoring plan
4.3.1
4.3.2
4.3.3
4.3.4
4.3.5
4.3.6
4.3.7
4.3.8
4.3.9
4.3.10
4.3.11
4.3.12
4.3.13
4.4 Calibration
4.5 Review and approval
4.6 Response to a deviation during monitoring
5 Periodic classification of air cleanliness by particle concentration
Annex A
A.1 Risk assessment considerations
A.1.1 Selection of an appropriate risk assessment tool
A.1.2 Definition of required performance and operating conditions that may need to be monitored
A.2 General considerations
A.2.1
A.2.2
A.2.3
A.2.4
A.2.5
A.2.6
A.2.7
A.2.8
A.2.9
A.2.10
A.2.11
A.2.12
A.2.13
A.2.14
A.2.15
A.2.16
A.2.17
A.2.18
A.2.19
A.2.20
A.2.21
A.3 Pressure differential monitoring
A.3.1
A.3.2
A.3.3
A.3.4
A.3.5
A.4 Airborne particle monitoring system
A.4.1
A.4.2
A.4.3
A.4.4
A.4.5
A.4.6
A.5 Airflow velocity and volume monitoring
A.5.1
A.5.2
A.5.3
Annex B
B.1 General basis for setting alert and action levels
B.2 Setting alert and action levels for pressure differential monitoring
B.2.1 Establishing the normal operational range for pressure differentials
B.2.1.1 The impact of operating airlock doors
B.2.1.2 The impact of process equipment
B.2.2 Setting alert and action levels
B.2.2.1
B.2.2.2
B.2.2.3
B.2.2.4
B.2.3 Pressure differential instrumentation
B.2.3.1
B.2.3.2
B.3 Setting alert and action levels for airborne particle counts
B.3.1 General guidance
B.3.1.1
B.3.1.2
B.3.1.3
B.3.1.4
B.3.2 Establishing normal operating range for particle counts
B.3.2.1
B.3.2.2
B.3.2.3
B.3.2.4
B.3.3 Setting alert and action alarm levels for particle counts
B.3.3.1
B.3.3.2
B.3.3.3
B.3.3.4
B.3.3.5
B.3.3.6
B.3.3.7
B.3.3.8
B.3.4 Possible alternate strategies for warning levels for particle counts
B.3.4.1
B.3.4.2
B.3.4.3
Bibliography
Cited references in this standard
[Current]
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
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