Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies

Good Manufacturing Practice (GMP) requires manufacturers of finished bio/pharmaceutical products to effectively clean their facilities and equipment prior to production and disinfect regularly to ensure product safety.

The key to successful facility cleaning is understanding the complete process, including the unique differences between materials cleaning validation and disinfectant efficacy studies, how the two processes are related and the challenges associated with each.

An effective cleaning, disinfection and monitoring program includes three distinct activities:
  1. Establishing that the cleaning program is effective in removing any product without leaving chemical cleaning agent residues.
  2. Ensuring that any disinfectants used in the processes are effective at decreasing or eliminating the microorganism levels on the surfaces and equipment.
  3. Performing chemical and microbiological monitoring to confirm that chemical residues and bioburden are within acceptable limits for the area

Establishing the effectiveness of disinfectants is an important component of a facility cleaning and environmental monitoring program, though the variables related to disinfection of surfaces, along with the time and labor required to conduct these studies, can make the process complex.

During this presentation, you will learn how to establish the best and most cost-effective approach to a cleaning, disinfection and monitoring program, including:
  • Best practices for chemistry cleaning validation.
  • Best practices for microbiology cleaning validation.
  • Understanding the difference between cleaning validation and disinfectant studies and how they relate.
  • Challenges and variables related to disinfection of surfaces.
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