Background
There are multiple strategies employed for controlling the manufacturing environment for the safe manufacture of pharmaceutical products and medical devices. These strategies include engineering controls (e.g. HEPA filtration and air pressure differentials), environmental controls (e.g. gowning procedures and material/personnel transfer processes), and routine disinfection of the cleanroom spaces with the application of disinfectants in a procedurally driven method.
While disinfectant manufacturers have executed a scope of work to determine the effectiveness of recommended contact times, the FDA, and other international regulatory bodies, require drug manufacturers to demonstrate the effectiveness of the commercially available disinfectants, in each respective companies’ hands.
Disinfectant Efficacy Studies (DES) are performed to demonstrate that disinfectants utilized in a controlled manufacturing environment are effectively reducing microbial populations within specific conditions. This means that the efficacy of the disinfectant is demonstrated on the surfaces that they are applied to, with the associated application methods, and against a broad panel of microorganisms, including facility isolates recovered during Environmental Monitoring (EM) of the cleanroom spaces.
The purpose of this whitepaper is to outline BA Sciences approach to DES to effectively and accurately demonstrate the efficacy of disinfectants in cleanroom spaces with data driven cGMP assessments.
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