Improve Efficiency In Bio-Contamination Control And Risk Mitigation

By James Drinkwater

There is a need to improve the efficiency in the pharmaceutical industry to meet new challenges of globalisation, competitiveness and the increasing diversity of products. The risk of biological contamination is increasing and, unchecked, is a risk factor for production processes and product quality, with potentially damaging consequences on business performance and risks to patient health.

This white paper considers environmental monitoring and contamination control strategies using the benchmark hydrogen peroxide vapour (HPV) gaseous bio-decontamination process. Using best practice and the latest technology, significant efficiency savings can be identified at different process stages.

Quality Risk Management (QRM) needs to consider the inefficiencies in microbiological monitoring. The forthcoming revisions to the ISO14698 standard on bio-contamination in cleanrooms and controlled areas and the USP<1116> microbiological control and monitoring of aseptic processing environment chapter, will place more emphasis on ‘contamination rates’.