Training activity: 5

Details

Run preparation sessions for a range of aseptic products, from order to release, including prioritisation of work

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
• Time management and prioritisation
• Checks required to sign off the unit prior to work commencing
• Aseptic verification of worksheets
• Label checks and reconciliation
• Unit verification (sign off) before commencing work)
• Workflow
• Rota management and allocation of staff according to workload
• In-process checking
• Preparation
• Product segregation
• Pre-release checks
• Release process
• Management of errors
• Management of deviations
• Product flow through the unit
• Roles and responsibilities of staff members
• Impact on patient treatment
• Limits of practice

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.
# 5	Outcome Develop and implement standard operating procedures (SOPs) and related documentation for a range of processes.
# 6	Outcome Apply risk management techniques in the context of aseptic medicines.