Competency information


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


  • Differences when working under the regulations for licensed premises or Section 10 Exemption. 
  • Limitations relating to the licensed status of the premises; preparation for individual patients, preparation for stock. 
  • Basic clean room design, layout and function of plant/air handling units, different work zones, processing environments’ airflow types, including aseptic suites, laminar flow cabinets, isolators and satellite units.
  • Range of aseptically prepared products and their intended use; central intravenous additives, parenteral nutrition and cytotoxic preparations.
  • Requirements for safe handling, storage and transportation, including waste disposal and Control of Substances Hazardous to Health.
  • Temperature control and monitoring of starting materials and finished products, before, during and after preparation, including storage areas and transport. 
  • Creation of SOPs and their purpose within the wider quality management system. 
  • Working to SOPs, and recognising the limits of your role and referral procedures.
  • Local changing procedures, as appropriate to specific workstations
  • How to calculate and select the appropriate components
  • How to assemble the components and record individual details on worksheets and batch records
  • Routine environmental checks, before, during and after preparation, and actions to be taken with out-of-range results.
  • Quality management systems, including quality control.
  • EU Good Manufacturing Practice, Good Clinical Practice, Good Scientific Practice, Good Laboratory Practice relating to the working environment,

Relevant learning outcomes

# Outcome
# 2 Outcome Complete hand and gowning validation. 
# 3 Outcome Undertake aseptic transfer (decontamination) operation.