Competency information

Details

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

Considerations

  • SOPs.
  • Equipment, including approved starting materials and consumables, laminar air flow cabinets and isolators (types, advantages, limitations, routine maintenance).
  • Correct use of laminar cabinets and isolators, including cleaning.
  • Transfer of materials to critical zones.
  • Correct disinfection technique; spray/wipe/spray.
  • Theoretical principles of aseptic manipulation.
  • Performing and recording in-process checks.
  • Potential sources of contamination:
    • chemical composition
    • pH
    • sterility (eg microorganism contamination)
    • pyrogenicity
    • biological or therapeutic potency
    • physical appearance
    • particulate matter (eg dust, glass or precipitation)
    • people
    • air supply
    • infilitration and preparation area
  • Indications for parenteral medication.

Relevant learning outcomes

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