Module information
Module details
- Title
- Aseptics
- Type
- Specialist
- Module code
- S-PS-S1
- Credits
- 10
- Phase
- 2
- Requirement
- Compulsory
Aim of this module
This module will enable students to gain skills and experience of the work of an aseptic unit to enable them to provide a safe and high-quality aseptic service to patients.
Work-based content
Training activities
| # | Learning outcome | Training activity | Type | Action |
|---|---|---|---|---|
| # 1 | Learning outcome 1, 2 |
Training activities
Complete local departmental operator training for product preparation and prepare a product |
Type DTA | Action View |
| # 2 | Learning outcome 3, 4, 6 |
Training activities
Carry out a critical review of maintenance reports and annual schedule for PPM testing and make recommendations |
Type DTA | Action View |
| # 3 | Learning outcome 3, 4, 6 |
Training activities
Write a deviation report of an equipment failure and carry out an investigation into this failure |
Type DTA | Action View |
| # 4 | Learning outcome 2, 3, 4, 6 |
Training activities
Trend and critically evaluate physical and microbiological environmental monitoring results and develop action plans to correct any failures and prevent a recurrence |
Type ETA | Action View |
| # 5 | Learning outcome 1, 2, 3, 5, 6 |
Training activities
Run preparation sessions for a range of aseptic products, from order to release, including prioritisation of work |
Type ETA | Action View |
| # 6 | Learning outcome 1, 2, 3, 6 |
Training activities
Carry out a range of sessional, daily, weekly and quarterly environmental monitoring tests, to include:
|
Type ETA | Action View |
| # 7 | Learning outcome 5, 6 |
Training activities
Produce necessary documentation for a new, aseptically prepared product, following an appropriate change control process |
Type DTA | Action View |
| # 8 | Learning outcome 4, 6 |
Training activities
Critically evaluate a clean room facility against the current best practice guidance for design and installation taking into account local constraints |
Type DTA | Action View |
| # 9 | Learning outcome 5, 6 |
Training activities
Critically evaluate clean room procedures and suggest improvements. To include:
|
Type DTA | Action View |
| # 10 | Learning outcome 5, 6 |
Training activities
Deliver training to staff working within the aseptic unit and assess success of the training |
Type ETA | Action View |
Assessments
Complete 2 Case-Based Discussions
Complete 2 DOPS or OCEs
Direct Observation of Practical Skills Titles
- Clean an isolator/LAFC.
- Clean a cleanroom following a shutdown.
- Make a product using aseptic techniques.
- Transfer items from a support room into a critical zone.
- Perform appropriate hand hygiene and changing processes for entry to an aseptic area.
- Successfully carry out an operator broth transfer test.
- Carry out aseptic verification of a worksheet and labels.
Observed Clinical Event Titles
- Discuss the clinical check process for chemotherapy prescriptions with a clinical pharmacist, including discussion of clinical test results and any changes to dose or treatment schedule.
- Discuss with a nurse a delay to a patient’s treatment being ready.
- Provide specialist advice on an aseptically prepared product to a healthcare professional.
- Investigate an error and report it to the National Aseptic Error Reporting Scheme.
Learning outcomes
| # | Learning outcome |
|---|---|
| 1 | Demonstrate appropriate cleanroom comportment and management of the cleanroom facility, to ensure safe preparation of aseptic products. |
| 2 | Perform a range of tests to ensure the quality of aseptic products. |
| 3 | Interpret monitoring results and trends and take appropriate action to correct out of specification results. |
| 4 | Critically evaluate the design, installation and PPM of an aseptic unit and LAFCs/Isolators. |
| 5 | Develop and implement standard operating procedures (SOPs) and related documentation for a range of processes. |
| 6 | Apply risk management techniques in the context of aseptic medicines. |
Clinical experiences
Clinical experiences help you to develop insight into your practice and a greater understanding of your specialty's impact on patient care. Clinical experiences should be included in your training plan and you may be asked to help organise your experiences. Reflections and observations from your experiences may help you to advance your practice and can be used to develop evidence to demonstrate your awareness and appreciation of your specialty.
Activities
- Observe a tender or procurement process for a new equipment or service.
- Observe annual recommissioning tests to appreciate the coordination required for the range of test and stages of requalification to accept the unit back into use.
- Observe a clinic where products are administered to patients to appreciate the impact on patient care and experience.
- Observe a ward round or multidisciplinary team meeting to appreciate the impact of products on patient care and experience.
- Shadow a healthcare professional assessing organisational risk.
- Meet with the clinical trails team to appreciate the processes and requirements for running a clinical trial.
Academic content (MSc in Clinical Science)
Important information
The academic parts of this module will be detailed and communicated to you by your university. Please contact them if you have questions regarding this module and its assessments. The module titles in your MSc may not be exactly identical to the work-based modules shown in the e-portfolio. Your modules will be aligned, however, to ensure that your academic and work-based learning are complimentary.
Learning outcomes
On successful completion of this module the trainee will be able to:
- Critically evaluate standards, practices and quality assurance arrangements relating to aseptic preparation and manufacture of medicines, the differences between these, and their application to patient safety and patient-centred care.
- Critically analyse the procedures required for outsourcing and sub-contracting services relating to aseptics.
- Critically analyse pharmaceutical microbiological aspects of aseptic preparation and their application in the workplace.
- Critically evaluate the design, commissioning, and use of clean rooms/clean air devices.
- Critically evaluate process and operator validations.
- Discuss human factors and how it relates to errors, deviations and CAPA.
- Apply integrative knowledge of the formulation, stability and preparation of specialist, aseptic dose forms.
- Investigate emerging therapies and technologies related to aseptic services.
Indicative content
- Discuss and justify all standards, practices and quality assurance arrangements relating to aseptic preparation or aseptic manufacture of medicines and their application to patient safety and patient-centred care.
- Standards and guidance (licensed and unlicensed activity)
- Organisational risk strategy
- Process design
- Quality assurance and release of finished products
- Horizon scanning
- Critically analyse procedures required for outsourcing and sub-contracting services relating to aseptics.
- Outsourcing aseptic preparation
- Sub-contracting services
- Cleanroom monitoring
- Cleaning
- Cleanroom clothing
- Planned preventative maintenance (PPM)
- Critically analyse pharmaceutical microbiological aspects of aseptic preparation and their application in the workplace.
- Microbiological monitoring requirements
- Monitoring programs
- Trending
- Maintenance of aseptic environment
- Critically evaluate the design, commissioning and use of clean rooms/clean air devices.
- Ensuring all relevant standards are met
- Cleanroom design and construction
- Equipment design and construction
- Critically evaluate process and operator validations.
- Discuss human factors and how it relates to errors, deviations and CAPA.
- Apply integrative knowledge of the formulation, stability and preparation of specialist, aseptic dose forms.
- PN
- Gene therapy
- ATMPs
- Investigate emerging therapies and technologies related to aseptic services.
- Troubleshoot equipment and preparation issues.
- AHU
- Clean air devices
- Product preparation issues
- Trending issues
- Environmental monitoring