Microbial Control for Nonsterile Drug Manufacturing Product Contact Surfaces

There is an understanding of how cleaning processes for pharmaceutical equipment used in aseptic operations are implemented not only for controlling drug product cross-contamination, but also for the initial reduction in bioburden prior to sterilization. However, there is limited guidance on bioburden limits for product-contact surfaces on equipment used to manufacture non-sterile products. This lack of information and regulatory requirements prompts questions on whether it is necessary to have a separate sanitization or disinfection step after cleaning of equipment product-contact surfaces for nonsterile drug manufacturing. Per USP <1115>, microbial limits and the design for cleaning and other associated processes should be based on risks assessed and the level of control necessary based on the product. It would be beneficial to implement processes that can address both product residual and microbial contamination of equipment surfaces. Multiple factors play into the design of an effective and efficient cleaning process. When adequate controls are implemented for the cleaning process and its associated factors, a separate sanitization or disinfection process may not be needed for product-contact surfaces when data is able to demonstrate that the cleaning process and the other preventive measures are able to control microbial contamination of those surfaces.