An Evaluation of the Routes of Bacterial Contamination Occurring During Aseptic Pharmaceutical Manufacturing

Abstract

Experiments were carried out to establish the amount of bacterial contamination derived from the air and hands of operators and its influence on a semi-automatic vial filling operation in an Aseptic Production Area. Air and hand contamination were found to be important factors, accounting for practically all of the contamination. Only by use of a Class I environment, with an associated microbiology count of less than 1/m3, and adoption of the best hand protection was it possible to achieve the product contamination standard suggested by the Parenteral Drug Association (1) (0.1%). All of the bacteria contaminating the vials were found to be Gram-positive. These bacteria were identified and found to be the type derived from people and correlate with those isolated from the air and the operator's hands. The significance of this as well as the experience of the operator and the efficiency of hand washing techniques are discussed.