Module information
Module details
- Title
- Introduction to Aseptics
- Type
- Rotation
- Module code
- S-PS-R2
- Credits
- 10
- Phase
- 1
- Requirement
- Compulsory
Aim of this module
This rotation will introduce trainees to principles and practices of aseptics services in clinical pharmaceutical sciences. Trainees will appreciate the range of products which require aseptic preparation and the application in patient care. Trainees will be introduced to the roles and responsibilities of the multidisciplinary team working in an aseptic unit and regulation which guides the process of preparing products.
Work-based content
Training activities
| # | Learning outcome | Training activity | Type | Action |
|---|---|---|---|---|
| # 1 | Learning outcome 1,2,3,6 |
Training activities
Attend a multidisciplinary team meeting where patients having treatments provided by aseptic services are discussed and reflect on the meeting |
Type OTA | Action View |
| # 2 | Learning outcome 1,2,3,6 |
Training activities
Shadow the authorised Pharmacist and reflect on their role |
Type OTA | Action View |
| # 3 | Learning outcome 1,2,3,6 |
Training activities
Shadow the sessional lead responsible for the organisation of the aseptic workflow and reflect on their role |
Type OTA | Action View |
| # 4 | Learning outcome 1,2,3,6 |
Training activities
Observe the preparation of a product and reflect on the process |
Type OTA | Action View |
| # 5 | Learning outcome 1,2,3,6 |
Training activities
Follow the pathway of a product from prescription to administration and reflect on the journey |
Type OTA | Action View |
| # 6 | Learning outcome 1,3,4,6 |
Training activities
Explore current clinical trials involving aseptic products and reflect on the impact this will have on practice |
Type OTA | Action View |
| # 7 | Learning outcome 1,3,5,6 |
Training activities
Review the effect of Good Manufacturing Practice (GMP) guidance on aseptic services and reflect on how this guides practice |
Type OTA | Action View |
| # 8 | Learning outcome 1,2,3,6 |
Training activities
Shadow the person with overall responsibility for the aseptic service for example the accountable pharmacist, QC lead or production lead, and reflect on their role |
Type OTA | Action View |
| # 9 | Learning outcome 1,2,3,6 |
Training activities
Observe the assembly of the starting materials and consumables for an aseptic product and reflect on the process |
Type OTA | Action View |
| # 10 | Learning outcome 1,2,3,6 |
Training activities
Observe cleaning and sanitisation processes and reflect on the processes |
Type OTA | Action View |
Assessments
Complete 1 Case-Based Discussion
Complete 1 DOPS or OCE
Direct Observation of Practical Skills Titles
- Perform handwashing and gowning to enter the cleanroom.
- Perform an aseptic transfer process.
- Perform weekly settle and contact plates in a cleanroom.
- Perform sessional cleaning of a cleanroom or clean air device.
Observed Clinical Event Title
- Gather a patient history relevant to the specialty from a patient, patient representative, or a member of the multidisciplinary team.
- Present a patient history relevant to the specialty to a member of the multidisciplinary team.
Learning outcomes
| # | Learning outcome |
|---|---|
| 1 | Explore the contribution of the Pharmacy Aseptic Unit to patient care. |
| 2 | Identify the roles and relationships of the multidisciplinary team in the Pharmacy Aseptic Unit. |
| 3 | Describe the working practices of the Pharmacy Aseptic Unit. |
| 4 | Examine the impact of innovation in the Pharmacy Aseptic Unit. |
| 5 | Review the effect of legislation in the Pharmacy Aseptic Unit. |
| 6 | Compare and contrast the practices of the Pharmacy Aseptic Unit with other areas of the Pharmaceutical Sciences. |
Clinical experiences
Activities
There is no clinical experiential learning associated with this module.
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:
- Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, related to aseptic preparation, manufacture and quality assurance.
- Discuss standards and guidance relevant to aseptic preparation and aseptic manufacture including the requirements for documentation in aseptic services.
- Demonstrate extended understanding of how a cleanroom functions to maintain a clean environment.
- Explain the principles of aseptic manipulation, transfer processes, and cleanroom comportment within pharmacy aseptic services.
- Describe the principles of basic pharmaceutical microbiology and environmental monitoring in pharmaceutical aseptic services.
- Critically appraise the application of cleaning and disinfection agents and methods pharmaceutical aseptic services.
- Explain key chemical and physical reactions affecting the stability of medicinal products.
- Critically appraise common errors in aseptic processes and their potential consequences.
Indicative content
- Discuss the role of the Clinical Scientist in Pharmaceutical Sciences in ensuring the safety of the patient, related to aseptic preparation, manufacture and quality assurance.
- Discuss standards and guidance relevant to aseptic preparation and aseptic manufacture including the requirements for documentation in aseptic services.
- Pharmaceutical quality system
- Procedures
- Worksheets
- Equipment logs
- Training records
- Demonstrate extended understanding of how a cleanroom functions to maintain a clean environment.
- Construction
- Air flow
- Unit design and process flow
- Explain the principles of aseptic manipulation.
- Practical application of quality assurance
- Aseptic technique
- Compliance with regulatory and operational requirements
- Effective working within aseptic processing environments
- Explain cleanroom comportment.
- Gowning
- Behaviour
- Safe and unsafe practices
- Training
- Transfer processes.
- Agents
- Methods
- Validation
- Describe the principles of basic pharmaceutical microbiology.
- Microorganisms, microbial growth (form and actions of microbes)
- Sources and control of microbiological contamination
- Potential risks from microbial contamination (pathogens and infection risks)
- Describe the principles of environmental monitoring.
- Critically appraise the application of cleaning and disinfection agents and methods.
- Agents
- Methods
- Equipment
- Validation
- Explain key chemical and physical reactions affecting the stability of medicinal products.
- Critically appraise common errors in aseptic processes and their potential consequences.
- Recognise how human factors can impact on errors, deviations and CAPA.