Training activity information
Details
Complete local departmental operator training for product preparation and prepare a product
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
- Safe and accurate working
- Cleanroom comportment and behaviours
- Aseptic technique
- Unit SOPs
- Gowning
- Periodic operator validation and process validation
- Transfer sanitisation
- Cleaning and disinfection
- Clinical impact of non-compliance and deviation
- Product documentation
- Sickness reporting and fitness to work risk assessment.
- 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 are the specific goals of the local departmental operator training? What competencies should you demonstrate upon completion?
- What specific product(s) will you be preparing? What are the critical steps and quality checks involved in their preparation?
- What are the local Standard Operating Procedures (SOPs) for product preparation and cleanroom behaviour? Where can you access these?
- What are the specific requirements for gowning and entry into the aseptic area where you will be preparing the product?
- What potential risks are associated with the product(s) you will be preparing and how are these mitigated?
- What checks are required on raw materials and the environment before starting preparation?
- Who are the key personnel you can ask for guidance or clarification during the training and preparation?
- What aspects of cleanroom management and comportment do you want to focus on developing?
- What challenges do you anticipate in preparing the product, and what learning opportunities might these present?
- What theoretical knowledge about aseptic techniques, pharmaceutical calculations, and quality control do you need to review before starting?
- Have you familiarised yourself with the equipment and materials you will be using?
- What potential challenges might you face (e.g., time constraints, equipment malfunction, complex manipulations), and how might you handle them?
In action
- How are you approaching the product preparation following the training?
- Why are you following these specific steps?
- How effective are your actions in achieving the product preparation?
- Are you encountering any difficulties?
- Is the process flowing smoothly?
- What challenges are you facing during this activity?
- Are there any steps that are more complex than anticipated?
- Are there any equipment issues?
- Are you identifying any gaps in your understanding or the training provided?
- Are you drawing on previous experiences or knowledge during the preparation process?
- If you encounter a problem, are you thinking about ways to proceed (within the SOP) and when to escalate to a more senior staff member?
- Are there any points where you feel unsure and would benefit from immediate clarification?
On action
- What were the key steps involved in the local departmental operator training for product preparation?
- What specific aspects of cleanroom comportment and management were emphasised during the training and your preparation of the product?
- What procedures were involved in preparing the product?
- What quality checks were performed during and after the product preparation?
- Were there any deviations from standard procedures, and if so, what were they?
- What new knowledge or skills did you acquire regarding aseptic product preparation?
- How did the local training enhance your understanding of cleanroom practices?
- What insights did you gain into the importance of each step in the preparation process for ensuring product quality and safety?
- Were there any unexpected challenges you encountered during the training or preparation? What did you learn from these challenges?
- How did this activity contribute to your ability to demonstrate appropriate cleanroom comportment and prepare aseptic products safely?
- Did you develop or improve any specific skills related to quality testing of aseptic products?
- What areas for continued development have you identified in your aseptic product preparation technique or understanding of cleanroom practices?
- How will you apply the knowledge and skills gained from this training to future product preparation activities?
- What specific actions or ‘next steps’ will you take to further enhance your competency in this area?
- Do you require any further support or resources to develop in this area?
Beyond action
- Have you had opportunities to prepare further aseptic products since completing this initial training and activity? How do these later experiences compare to your initial one?
- Can you identify specific skills or knowledge gained during this training activity that you have applied in subsequent training activities or routine work?
- Consider discussions with peers or your training officer about aseptic product preparation. Has their perspective altered your understanding of your initial experience?
- How has your understanding of the practicalities and importance of following local procedures for product preparation evolved since this training activity?
- Can you identify specific instances where the skills learned in this training activity have helped you in other tasks within the aseptic unit (e.g., environmental monitoring, documentation)?
- How has this foundational experience contributed to your overall confidence and competence in aseptic techniques?
- Has your awareness of potential errors or challenges during product preparation changed based on subsequent experiences or learning?
- How has this initial experience shaped your approach to learning new aseptic procedures or using new equipment?
- What actions for continued development in aseptic product preparation have been highlighted by revisiting this early experience?
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. |