Monitoring to provide Evidence of Clean room performance related to air cleanliness by Particle concentration ISO 14622-2

1. Monitoring plan for Clean

room/ Clean zone
Performance

Related to air cleanliness by 4.1 Principle

Particle concentration 4.3 Monitoring plan To gain assurance that clean room/clean zone
review and approval is performing adequately
4.3.2 Parameters that
affect airborne particle Deliver required control of air by particle
conc. conc.
Monitoring plan shall be created, implemented,
A1. Risk assessment consideration
4.6 Response to the Monitoring Investigation shall and maintained
plan results If Exceed the specified be conducted
Critical locations Use appropriate 4.2 risk assessment
limit tool
Performance attributes of the
clean room

Pressure differential
Airborne particle monitoring
system
Frequency and duration of collection
Temperature and humidity
 Systematic process of identification, analysis
3.3-3.4 Consideration for and evaluation of hazards that may affect the
ability to maintain air cleanliness.
setting alert and action levels
 Determine the monitoring requirements to
provide evidence of performance.

Cleaning Procedures and agents

Fumigation agents

Product material or process hazards

Impact of Sampling system