An Environmental Monitoring (EM) program must rapidly detect deviations from established alert/action limits that can compromise the facility’s state of control. The trend analysis highly depends on the methodology used to recover environmental microorganisms: this includes the type of culture media, but also the incubation time and temperature to grow the stressed clean rooms’ organisms.

Dual temperature incubation is currently among the most common practices in EM. There is increasing interest, however, in exploring the advantages of a well-defined single temperature incubation approach. In an ever-evolving and highly competitive industrial market, the adoption of a single temperature strategy not only increases process efficiency for pharmaceutical manufacturers, but it also mitigates the risk of errors caused by a dual temperature approach.

Our white paper presents the results and explains the methodology used at Sanofi (Marcy l’Étoile Site - France) to evaluate the suitability of a single incubation temperature for EM. It discusses the challenges of one media / one temperature incubation, with a real case study and evaluates the sustainability of a single incubation temperature strategy for EM.

Download the whitepaper.

Want to know more about 3P^®ENTERPRISE, an end-to-end solution that fully digitalizes and automates the EM process? Visit our website.