Training activity information
Details
Undertake and report physical monitoring of cleanrooms to include:
- Particle counts
- Active air samples
- Room pressure differentials
- Air flow velocities in clean air devices
- Room air change rates
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Cleanroom comportment
- Permit to work
- Performance of testing – at rest or operational
- Sampling locations
- Test equipment used
- Test protocols used
- Equipment calibration
- Data integrity
- Reporting of results
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Apply physical and environmental monitoring tests to provide evidence of facility compliance and ascertain compliance with requirements. |
| # 5 |
Outcome
Investigate questionable laboratory results or out of trend results following quality system requirements, liaising with analysts, supervisor and customers where appropriate. |
| # 7 |
Outcome
Describe the requirements of data integrity related to quality control systems. |