Aseptics —
Training activity: 6

Details

Carry out a range of sessional, daily, weekly and quarterly environmental monitoring tests, to include:

• All of the following:
  • Pressure differentials
  • Pressure drops across filters
  • Air change rates
  • Temperature
  • Air flow in cabinet/isolator

 

• At least five of the following:
  • Isolator shutdown leak test
  • Active air sampling
  • Finger dabs
  • Contact plates
  • Settle plates
  • Surface swabs
  • Particle monitoring/continuous particle monitoring

Type

Entrustable training activity (ETA)

Evidence requirements

Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion. ​

Reflection at multiple timepoints on the trainee learning journey for this activity.

Considerations

• Regulatory requirements and National guidance
• Local SOPs
• Range of testing
• Routine testing
• Re-commissioning
• Testing due to failure/deviation
• Roles and responsibilities of staff involved
• Limits of practice
• Recording of results
• Action taken in case of out of specification results

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 does success look like?
  • How will you clearly identify what is expected of you regarding the accurate and precise execution of the specified environmental monitoring tests?
  • In what ways will you demonstrate appropriate cleanroom comportment and technical proficiency while performing this range of tests to ensure the quality and safety of aseptic products?
  • What specific points will you discuss with your Training Officer to gain clarity on the precise execution and recording requirements, including the acceptable ranges and frequency for each test?
• What is your prior experience of this activity?
  • What existing knowledge do you have regarding specific tests such as pressure differentials, active air sampling, and particle monitoring?
  • How will your previous observations of these tests being performed by others inform your own practical approach?
  • How will you handle anticipated challenges, such as ensuring the accuracy of measurements, handling specialized equipment, or adhering strictly to detailed protocols?
  • How will you recognise the scope of your own practice, ensuring you understand which tasks you can perform independently and at what point you must seek advice or help?
  • How do you honestly feel about embarking on this activity—are you confident in your practical skills and your ability to follow procedures with the required level of meticulous detail?
• What do you anticipate you will learn from the experience?
  • Which specific skills—such as precise test execution, calibration techniques, or detailed data recording for regulatory compliance—do you want to develop by drawing on your previous experiences?
  • What specific insights do you hope to gain regarding the interplay between different environmental parameters and the significance of each test for maintaining aseptic safety?
  • What do you hope to learn about the common issues or pitfalls encountered during the execution of these monitoring tests?
• What additional considerations do you need to make?
  • How will you consult and apply actions identified from previous practical testing experiences to improve your attention to detail in sample collection or your adherence to time limits?
  • What important information must you review before you begin, such as specific test protocols, cleanroom safety procedures, or the required reporting templates for results?

In action

• Are you noticing anything surprising or different from what you anticipate while carrying out the environmental monitoring tests?
  • Are you encountering situations such as:
    • An equipment issue (e.g., monitor malfunction, sampler error) during a test?
    • An immediate out-of-specification result for a parameter (e.g., pressure, particles)?
    • Difficulty with a specific test procedure or technique (e.g., accurate finger dabs, proper placement of settle plates)?
    • Unexpected environmental conditions in the cleanroom or isolator?
• How is any unexpected development being resolved as you progress during the activity?
  • How are you working within your scope of practice? Are you successfully managing the situation within your authority, or do you need support because it is beyond your current scope (for example, escalating an out-of-specification result or a persistent equipment malfunction)?
  • What are you learning in this moment as a result of any unexpected development? For example, are you learning a deeper understanding of equipment sensitivities, the nuances of specific test procedures, or the importance of immediate deviation reporting?
• How is this impacting your actions? For example, are you responding to the situation appropriately? Are you adapting or changing your approach to the procedure? Is it affecting your ability to undertake the activity independently?
  • Consider the steps you are taking in the moment, such as:
    • Are you troubleshooting equipment issues on the spot?
    • Are you re-performing a test immediately or documenting the deviation?
    • Are you seeking clarification on a protocol or a specific reading from a supervisor?
    • Are you adjusting your technique or approach to ensure accuracy?
  • How are you feeling in this moment? For example, are you finding it difficult to adapt? Is it affecting your confidence? Are you feeling positive you can reach a successful conclusion?

On action

• Summarise the key points of the experience of carrying out the specified range of environmental monitoring tests.
  • Consider specific events, actions, or interactions which felt important, including your own feelings during the experience. For example:
    • Describe the specific tests performed and the areas monitored
    • Detail any particular challenges encountered with equipment or techniques
    • Explain how you ensured accuracy and adherence to protocols
  • Include any ‘reflect-in-action’ moments where you adapted to unexpected developments as they unfolded, such as troubleshooting an equipment issue, re-performing a test due to an immediate out-of-specification result, or adjusting your technique for a specific monitoring procedure.
• Identify what learning you can take from the experience. What strengths did you demonstrate in performing tests accurately or managing cleanroom comportment during monitoring? What skills or knowledge gaps were evident, perhaps in understanding the nuances of specific testing methodologies or responding to immediate deviations?
  • Compare this experience against previous engagement with similar activities. Were any previously identified actions for development regarding environmental monitoring techniques or immediate issue resolution achieved? Has your proficiency in carrying out these tests improved?
  • Identify any challenges you experienced and how you reacted to these. Did encountering an unexpected reading or equipment error affect your ability to complete the tests efficiently? Were you able to overcome challenges related to precision or adherence to strict protocols?
  • Identify anything significant about the activity. Did you need to seek advice or clarification on a particular test procedure or an unexpected result? Or did you need to escalate a significant out-of-specification finding immediately to ensure you were working within your scope of practice and applying risk management techniques?
  • Acknowledge any changes in your own feelings now that you are looking back on the experience.
• Identify the actions / ‘next steps’ you will now take to support the assimilation of what you have learnt, including from any feedback you have received. For instance, what will you do differently next time you perform specific environmental monitoring tests?
  • Has anything changed in terms of how you would approach troubleshooting equipment or responding to immediate out-of-specification results?
  • Do you need to practise any aspect of the testing procedures or data recording further?

Beyond action

• Have you revisited previous experiences of carrying out environmental monitoring tests?
  • Have you reviewed your actions from your previous reflections on conducting different environmental monitoring tests (e.g., pressure differentials, air sampling, finger dabs)?
  • What specific actions did you identify you would need to take to improve your technique or understanding of these tests? Have you completed these actions? Are you ready to demonstrate this new learning into practice when performing environmental monitoring tests?
  •  Has your view of the importance or methodology of specific environmental monitoring tests changed because of analysing this with others?
• How have these collective experiences of carrying out environmental monitoring tests impacted your current practice?
  • Consider how the learning from consistently performing a range of environmental monitoring tests will support you in preparing for observed ‘in-person’ assessments, such as DOPS (e.g., ‘Clean a cleanroom following a shutdown’ or ‘Perform appropriate hand hygiene and changing processes for entry to an aseptic area’, which relate to maintaining the monitored environment) or Case-Based Discussions on quality control.
  • How has your practice in performing and understanding the significance of environmental monitoring tests developed and evolved over time?
  • Are you better able to identify when a test result or a situation is beyond your scope of practice and requires intervention or reporting?

Relevant learning outcomes

#	Outcome
# 1	Outcome Demonstrate appropriate cleanroom comportment and management of the cleanroom facility, to ensure safe preparation of aseptic products.
# 2	Outcome Perform a range of tests to ensure the quality of aseptic products.
# 3	Outcome Interpret monitoring results and trends and take appropriate action to correct out of specification results.
# 6	Outcome Apply risk management techniques in the context of aseptic medicines.