Bio/Pharmaceutical companies, and companies planning or currently building new facilities require a comprehensive cleaning program that includes, disinfection and environmental monitoring (EM). To comply with FDA 21CFR Part 210 & 211 or other regulations, these processes must be in a state of control. By establishing a rugged and reliable EM program (from EMPQ to routine sampling), the risk of a contamination event is less likely to occur. Product safety depends on the condition of your facility, as well as the team involved. Securing knowledgeable partners to plan and manage your EM program ensures a seamless and simplified process, building confidence that you are adequately prepared for regulatory body facility inspections.
When an EM sample shows growth, it’s critical to understand the impact on your operation. Once excursions are identified, they must then be investigated and appropriate actions taken to mitigate the issue. Demonstrating your facility’s cleaning program is effective by executing disinfectant efficacy studies is an essential part of the plan.
During this webinar, we will dive into: