Aseptic Services 1 (SPE201)

10 credits

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.

  1. Complete aseptic manipulation under supervision. 
  2. Complete hand and gowning validation. 
  3. Undertake aseptic transfer (decontamination) operation. 
  4. Interpret stability data when determining the shelf life of a range of products. 
Number Work-based learning outcome Title Knowledge
1 2,3

Work safely and accurately in accordance with standard operating procedures (SOPs), carrying out environmental checks and in- process checking procedures.

2 1,4

Critically evaluate key reference texts used in aseptic preparation and produce a short report identifying the strengths and limitations of each resource.

3 2,3

Demonstrate good clean room behaviours.

4 1

Assist in performing environmental microbiological and physical monitoring.

5 2,3

Perform practical aseptic manipulation of components using correct aseptic technique and the use of principal equipment, under simulation.

6 2,3

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.

7 1

Label a range of aseptically prepared products, including label validation, key information, legal requirements, label reconciliation and destruction.

8 1

Discuss the clinical context within which aseptically prepared products are used, including administration and the associated considerations.

9 1,4

Assist in the maintenance of routine documentation working consistently and making accurate entries on routine documentation and record keeping.

10 4

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
Assessment Title Type
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

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

  1. Discuss the role of the Clinical Scientist in Clinical Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture and quality control with reference to key patient care pathways. 
  2. Explain the principles of aseptic manipulation. 
  3. Describe the principles of basic pharmaceutical microbiology. 
  4. Explain key chemical and physical reactions affecting the stability of medicinal products.
  5. Resolve drug formulation and administration problems, particularly where they relate to the modification and optimisation.

Indicative Content

Clinical Pharmaceutical Science in key patient and care pathways

  • Diagnosis using radioactive materials
  • Treatment relevant to the patient and care pathway, including chemotherapy
  • Treatment using radioactive materials
  • The role of regulation, Good Manufacturing Practice, aseptic techniques and quality assurance in ensuring patient safety

Principles of aseptic manipulation

  • Practical application of quality assurance
  • Aseptic technique
  • Compliance with regulatory and operational requirements
  • Effective working within aseptic processing environments

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)
  • Spoilage and control/preservation

Maintenance of essential documentation

  • Completion of all logs, worksheets and reports
  • Completion of necessary training records