The current status of monitoring for process micro-organisms in biotechnology: Results of an industry questionnaire

In biotechnology-based industrial processing, micro-organisms may be handled in large concentrations in liquid culture (fermentation). Where biotechnology is used for high value products such as pharmaceuticals, conditions are usually controlled closely. Containment is important for safety and economic reasons, therefore release of the process organism and its products into the work environment is likely to be minimized. Nevertheless, instances can and do occur where containment is breached. Although monitoring the workplace for release of process organisms must be seen as advantageous from a worker safety point of view, no specific guidance is given to the biotechnology industry. We conducted a survey by questionnaire to find out what methods were being used to monitor for process micro-organisms or their products in biotechnology, what sampling methods were used, what use was made of acquired data, details of any standards used and any need for further information. This paper describes the questionnaire used in the survey and the results obtained. The results showed that a range of monitoring methods were being used in well-defined sampling strategies, the monitoring information being used to maintain or improve work conditions. However, a need was identified for further information on sampling methods and 'typical' levels of micro-organisms that may be anticipated in the biotechnology workplace.