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

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.