In-Situ Verification of Disinfection Rotation for Contamination Control

Pharmaceutical manufacturing companies have rotated different cleanroom disinfectants for many years. However, the reasons for this rotation have not always been clear, and if the question is posed to several different scientists, it is expected that varying reasons for rotating will be given. It is understood that regulators will also expect to see disinfectant rotation, but the written regulation giving guidance to this is considered quite vague. The updated European Union (EU) GMP Annex 1 "Manufacture of Sterile Medicinal Products" makes specific reference to rotating a sporicide as part of the regime. However, there is still no guidance available on how many or what chemistries to rotate, and the frequency of rotation to implement.

This evaluation of in-situ environmental monitoring testing results, at four manufacturing sites addresses the question as to whether the rotation of more than one broad-spectrum disinfectant is more effective than the use of only one within a disinfection regime.

In this study incorporating four manufacturing sites, the use of a single broad-spectrum disinfectant and a sporicide was demonstrated to be more effective than the rotation of two broad-spectrum disinfectants and a sporicide.

This evaluation provides data that demonstrates rotating two broad-spectrum disinfectants and a sporicide instead of one broad-spectrum disinfectant and a sporicide does not necessarily give any benefit in relation to environmental control. This has wider implications with regards to challenging the paradigm that rotating more than one broad-spectrum disinfectant in a cleanroom environment is preferable or beneficial.