Laura Bailey, Wickham Laboratories, outlines best practices in microbiological qualification and monitoring of environmental contaminants
As anyone involved in the development and manufacture of pharmaceutical products and medical devices knows, a clean environment is crucial to ensuring the safety and viability of the end product. Environmental monitoring describes the processes and activities that need to take place to characterise and monitor the quality of the environment. This monitoring provides evidence that the facility and documented procedures are fit for purpose in controlling product or device bioburden within specified limits.