RABS and Advanced Aseptic Processing

For at least 20 years, the global parenteral industry has recognized that personnel are the dominant risk relative to microbial contamination in aseptically produced sterile products (1). The contamination source strength of the gowned aseptic processing operator has been estimated in several research studies. Concomitant with this awareness, we have witnessed a series of technological advances that have endeavored to mitigate this contamination risk. These advances can be roughly categorized as follows:

* separate personnel from the aseptic environment;
* limit personnel interaction with sterile materials;
* remove personnel from the aseptic environment;
* some combination of the above.

Each of these approaches provides some added measure of security to the process by increasing the degree of separation provided between personnel and the sterilized materials, components, and product contact surfaces required for the aseptic assembly of the sterile product from its individual elements.

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