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US Food and Drug Administration (FDA)



Cleanroom microbiology: single-temperature incubation for EM

8 July 2024 | By

Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…