For manufacturers of sterile and nonsterile pharmaceuticals, there is an expectation that the manufacturing process is performed in a manner that prevents contamination to ensure product’s efficacy and safety. As part of this process, the validation of the efficacy of sanitizer products on in-use surfaces is a fundamental aspect in demonstrating the effectiveness of cleaning processes and microbiological monitoring for contamination-controlled environments.
After a disinfectant has been chosen based on its chemical properties and expected performance/effectiveness, each disinfectant should be validated to ensure its efficacy.
The U.S. FDA (United States Food and Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), amongst others, routinely make observations about disinfectant validation studies and disinfectant practices.
There are many different types and formats of disinfectants now available for use - The spectrum of products with bactericidal, fungicidal, sporicidal or combined action is very broad and multiple surfaces are involved. On the other hand there are various international efficacy testing standards available that use different methodologies.
Given the complex scenario, manufacturers need to carefully implement an adequate approach to ensure that potential contaminants are adequately removed from surfaces.
This webinar aims to provide participants valuable insights on how to define the best strategy to perform a correct validation of a sanitizer and the criteria most commonly applied.