Efficient shutdown recovery: leveraging RMM to unlock value and ensure environmental quality

New technologies are awaiting implementation by the pharmaceutical industry to improve and optimise processes, but as they are not compendial and may require lengthy approval processes, their adoption as a replacement for a compendial method is slow, if at all possible. Though the industry is still contemplating how to unlock the full benefits of these new methods, they can be used to generate value. In this article, Pfizer colleagues Victoria Navarro, Joanny Salvas and Esther Bellón share an example that employs new technologies alongside the compendial methods to ensure quality within a process common across pharmaceutical plants: post-shutdown recovery and room release for manufacturing.

ASEPTIC MANUFACTURING requires regular, planned – and sometimes unplanned – shutdowns to perform line improvements, area modifications, and/or preventative activities such as maintenance and qualifications. During these interventions, aseptic environmental conditions could be compromised. Subsequently, environmental area recovery must be demonstrated and documented before resuming operations. However, compendial environmental monitoring (EM) typically takes five to seven days to return results, meaning that the areas are not used for seven days. Such loss of capacity on a line is significant, even when the final EM results are within specification. In cases where the EM data indicates further assessment is warranted, this creates even longer delays to the remediation and complicates the investigation process.