Aim of this module
This rotation introduces trainees to aseptics and will enable them to gain skills and experience of the work of an aseptic services unit from the design of products, formulations testing (including microbiological), validation, quality assurance and dispensing to apply underpinning knowledge. Trainees will gain experience so that they are able to observe, assist, or perform a range of routine procedures in the context of providing high-quality, safe patient care and will be expected to develop and build their professional practice.
|Number||Work-based learning outcome||Title||Knowledge|
Work safely and accurately in accordance with standard operating procedures (SOPs), carrying out environmental checks and in- process checking procedures.
Critically evaluate key reference texts used in aseptic preparation and produce a short report identifying the strengths and limitations of each resource.
Demonstrate good clean room behaviours.
Assist in performing environmental microbiological and physical monitoring.
Perform practical aseptic manipulation of components using correct aseptic technique and the use of principal equipment, under simulation.
Perform a range of operator validations, including finger dabs, transfer validation, broth transfer challenge test, and follow the process of incubation, sampling, testing and reporting on results.
Label a range of aseptically prepared products, including label validation, key information, legal requirements, label reconciliation and destruction.
Discuss the clinical context within which aseptically prepared products are used, including administration and the associated considerations.
Assist in the maintenance of routine documentation working consistently and making accurate entries on routine documentation and record keeping.
Interpret stability data and determine the shelf life of a range of products.
|You must complete|
|1 Case-based discussion(s)|
|1 of the following DOPS / OCEs|
|Select ingredients and or equipment against an approved worksheet||DOPS|
|Undertake a hand wash and gown up procedure||DOPS|
|Demonstrate the transfer of materials to aseptic critical zones||DOPS|
|Monitor clean rooms laminar flow cabinets and or isolators||DOPS|
|Demonstrate a range of methods of aseptic manipulation under simulation||DOPS|
|Perform a broth transfer test||DOPS|
|Demonstrate effective cleaning of equipment and premises and identify key points for prevention of cross contamination||DOPS|
|Discuss associated clinical test results e.g. UandEs bloods with a clinical pharmacist and rationale for any change in formulation defer treatment||OCE|
|Accompany a clinical pharmacist and participate in a ward clinic visit||OCE|
|Observe release of a finished product against a prescription, and discuss critical steps||OCE|
|Observe administration of a finished product to a patient within a clinical environment||OCE|
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.
Clinical Pharmaceutical Science in key patient and care pathways
Principles of aseptic manipulation
Maintenance of essential documentation