Best practices in environmental monitoring automation

摘要

Best practices-based automation concepts for EM are actively promoted by leading, well respected industry organizations like PDA. These automation concepts are also consistent with the FDA initiative for process analytical technologies (PAT) , which aims to automate more of the drug manufacturing process, remove variability, anticipate problems, and make corrections earlier in the process before an entire product batch has to be rejected. Implementation of an automated, paperless, best practices-based solution for the entire QC microbiology process associated with EM, utility, and product testing, provides an opportunity for significant, tangible return on investment due to the reduction in time needed to execute the required protocols. An additional benefit is the immediate availability of higher-quality information that can quickly and accurately provide EM evidence to support batch release and ensure regulatory compliance.