Training of operators in aseptic techniques is a critical step in protecting the product from contamination. It is by understanding contamination sources and the transport mechanism of contaminants to the product that we can truly master and execute proper aseptic techniques. Contamination sources may stem from the inadequate design of the cleanroom or barrier system, improper cleaning, mismanagement of gowns as well as flawed gowning practices and more. To execute proper aseptic techniques, these sources of contamination should be considered. Any contamination source in the proximity of an open product has the chance to contaminate the product. When performing aseptic manipulations, there are some ground rules which need to be followed by the analysts or operators. Aspects to be considered are: never breaking first air or reaching overexposed product, components, or fill lines, not touching sterile items with nonsterile items, not exposing sterile items to nonsterile environments and using sterile components and gloves. These are the first steps to steering clear of contamination.
This holistic approach to aseptic techniques will be addressed in the two-day training, and the data resulting from the hands-on qualification exercise will be utilized as a measure of training efficacy.