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
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What is the purpose of PPM testing in the aseptic unit? What types of tests are typically included?
- What information should be contained within the maintenance reports you will be reviewing?
- What kind of recommendations are expected as an outcome of this critical review?
- What are the relevant guidelines and standards for PPM in aseptic units (e.g., HTM, GMP)? Where can you find these?
- What is the current annual schedule for PPM testing in your department? What equipment and areas are included?
- What is the departmental process for documenting and addressing maintenance issues and PPM findings?
- What are the typical types of failures or issues identified in maintenance reports for aseptic units?
- Who are the key individuals responsible for maintenance and PPM in the aseptic unit?
- Have you reviewed any background information on the design and installation of your aseptic unit and its critical equipment?
- Do you need to familiarise yourself with specific terminology or technical aspects related to PPM testing (e.g., HEPA filter integrity testing, air change rates)?
- What criteria will you use to critically evaluate the reports and schedule (e.g., completeness, frequency, findings, actions taken)?
In action
- How are you approaching the review of the maintenance reports and PPM schedule?
- What specific aspects are you focusing on?
- Why are you prioritising certain information?
- What decisions are you making as you progress through the documents?
- Are you deciding which information is most relevant? Are you identifying patterns or anomalies?
- How effective are your actions in critically reviewing the documents?
- Are you able to identify potential issues or areas for improvement?
- Are there any aspects of the reports or schedule that are unclear or difficult to interpret?
- Are you gaining a better understanding of maintenance procedures or PPM testing requirements?
- Are you applying knowledge of quality assurance or risk management to this review?
- Could you organise the data differently to identify trends?
- Are there any technical terms or procedures you need clarification on?
- Are you working within your understanding of best practice and local guidelines for PPM?
On action
- What information was included in the maintenance reports you reviewed?
- What was the scope and frequency of the planned preventative maintenance (PPM) testing outlined in the annual schedule?
- Were there any recurring issues or trends identified in the maintenance reports?
- How did the PPM schedule align with best practice and regulatory requirements (if you have this knowledge)?
- What potential risks or areas of concern did you identify based on your review?
- What did you learn about the maintenance requirements for an aseptic unit and its equipment?
- How did this activity enhance your ability to critically evaluate maintenance documentation and PPM schedules?
- What insights did you gain into the importance of PPM in maintaining a safe and effective aseptic environment?
- How did this review inform your understanding of potential risks associated with equipment failure or inadequate maintenance?
- Did you learn about the relationship between maintenance and environmental monitoring or product quality?
- How will you apply your understanding of maintenance reports and PPM schedules in future evaluations of aseptic units?
- What considerations will you now include when assessing the adequacy of maintenance and PPM?
- What specific recommendations did you make, and what was the rationale behind them? How will you follow up on these recommendations (if appropriate)?
- What further information or resources might you need to deepen your understanding of aseptic unit maintenance and risk management?
Beyond action
- Have you had further opportunities to review maintenance reports or PPM schedules? How did your subsequent reviews build upon your initial experience?
- Have you revisited your initial recommendations? Were any of them implemented? What were the outcomes?
- Have you compared the maintenance reports and PPM schedules for different equipment or areas within the aseptic unit? What similarities or differences did you observe?
- Have you discussed your findings and recommendations with engineering staff or senior colleagues? Did their feedback provide new insights into your initial review?
- Has your understanding of the importance of PPM and maintenance in ensuring a safe aseptic environment deepened since this training activity?
- Are you now more attuned to identifying potential issues or trends in equipment performance based on your experience with reviewing these reports?
- How has this activity contributed to your critical evaluation skills, particularly in the context of technical documentation?
- Has this experience influenced your approach to problem-solving related to equipment within the aseptic unit?
- How will your understanding of equipment maintenance and PPM inform your future involvement in quality assurance or facility management within an aseptic environment?
- What further learning or development in areas such as engineering principles or regulatory requirements for equipment maintenance might be beneficial based on this experience?
- How can you apply your skills in critically evaluating technical documentation to other aspects of your role?
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. |