Training activity information
Details
Carry out a critical review of maintenance reports and annual schedule for PPM testing and make recommendations
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
- Monthly, quarterly and annual maintenance and testing of the AHU and critical work zones
- AHU design
- Cleanroom design and airflow
- Isolators/LAFC design and airflow
- Relevant regulatory requirements and National guidance.
- Local SOPs for tests to be performed
- Test frequency
- Test limits
- Actions resulting from deviations
- Appropriate corrective actions from deviations/test failures
- Change control
- Risk assessment
- Prioritisation of actions
- Limits of practice
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Interpret monitoring results and trends and take appropriate action to correct out of specification results. |
| # 4 |
Outcome
Critically evaluate the design, installation and PPM of an aseptic unit and LAFCs/Isolators. |
| # 6 |
Outcome
Apply risk management techniques in the context of aseptic medicines. |