Objectives: To describe the application of the model described in part A and part B of this series of articles for risk assessment (RA) and risk control (RC) of non-sterility during aseptic handling. The model was applied in nine hospital pharmacies.
Methods: The starting point was an audit of each hospital pharmacy.
Objectives: To determine prospectively the sources of risk of non-sterility during aseptic handling and to quantify the risks of each of these sources.
Methods: A risk assessment (RA) of non-sterility according to Failure Mode and Effect Analysis was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. The team determined the sources of risk of non-sterility, a 5 point scale for severity, occurrence and detection, and risk acceptance levels.
Objectives: To determine prospectively the risk reducing measures of non-sterility during aseptic handling and to develop a method for prioritising these measures.
Methods: In the first part of this series of articles, we identified all sources of risk which could contaminate a product during aseptic handling, and calculated the remaining risks of non-sterility using a risk assessment (RA) model. We concluded that additional research of some risk sources was needed before risk control (RC) could be executed on all risk sources.