Table 1

Sources of risk of non-sterility during aseptic handling

CodeDescription
AAir in LAF/SC
BWorktop LAF/SC
CWall and ceiling LAF/SC
D1Materials with a sterile surface (tubes, syringes, needles, infusion bags, etc)*
D2Critical spots† such as the opening of tubes, syringe tips, needles, septa of infusion bags
E1Materials and equipment with a non-sterile surface (ampoules, vials, bottles, etc)*
E2Critical spots† such as vial stoppers, ampoule necks
FOperators' hands
GOperators' forearms
HWorking procedure
  • *For an extensive explanation see Boom et al.22

  • †A definition of ‘critical spots’ is given in online supplementary file 1.

  • LAF, laminar airflow cabinet; SC, safety cabinet.