GMP cleanrooms classification and routine environmental monitoring

18 Nov 2021

Designing and validating your Cleanroom Routine Environmental Monitoring and Classification SOPs is time consuming and complex. This application note discusses the differences between GMP Cleanroom Classification and Routine Environmental Monitoring and explains how Beckman Coulter can help.

MET ONE 3400+ Series Cleanroom Routine Environmental Air Particle Counter

Beckman Coulter Life Sciences

Our new MET ONE 3400+ Series Portable Airborne Particle Counter allows users to load their routine environmental monitoring SOP sampling map and sampling configuration for each location directly into the counter, so that the SOP becomes an interactive sampling map directly on the counter screen to guide users doing daily sampling. This helps reduce training requirements and sampling data errors/omissions.

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RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Environmental AnalysisEnvironmental analysis describes a variety of tests that determine the effect of chemicals, processes and particulates such as persistent organic pollutants (POPs) have on the environment.ISO CertificationProcess MonitoringManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.