Efficient environmental programs set-up

An effective environmental monitoring program should be scientifically justified, compliant with applicable requirements and sustainable in routine operations.

Environmental monitoring programs are sometimes built with excessive complexity, including sampling locations, frequencies or controls that are not fully justified by the cleanroom classification, process risks or regulatory expectations. This can lead to unnecessary time and costs, increased resource needs and a higher burden in the management of deviations or non-conformities.

SteriLandBio supports companies in the set-up, review and optimization of environmental monitoring programs for controlled environments, cleanrooms and critical manufacturing areas.

Our support may include the definition or rationalization of sampling locations, sampling frequencies, alert and action levels, microbiological and particulate monitoring strategies, trend analysis approaches, deviation management and alignment with cleanroom classification, process risks and contamination control principles.

We help companies build environmental programs that are compliant (ISO 14644 series, ISO 14698-1&2, EN 17141), meaningful and efficient, avoiding unnecessary complexity while maintaining an appropriate level of process control.