Cleaning and disinfection are crucial during the drug manufacturing process. However, while these tasks support the control of microbial contamination through preventive and corrective actions, specific compendia methods do not exist – yet cleaning and disinfection is now a regulatory requirement.
This is why BioPhorum’s Microbial Control Workstream has published Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program, which provides general guidance on how to perform disinfectant efficacy validation and implementation.
The paper has been published in the PDA Journal of Pharmaceutical Science and Technology. It includes how to ensure the concepts of disinfectant efficacy are understood, how to interpret facility data and use it to demonstrate control awareness for your facilities, and how to leverage the data to reduce redundancies in validation or verification. It also details an efficient way to qualify disinfectants without impacting the quality of the study. The recommended program could be more robust than any individual approach developed in any one site.
As regulators now require thorough validation studies, the BioPhorum paper is not about why you need to do disinfectant efficacy, but how you do it so you can meet that regulatory challenge for study data.
The paper will also help build a business case for change. With so many different surfaces and potential bugs to consider, an organization might spend hundreds of thousands of dollars on a site disinfectant efficacy study. Multiply that by a number of sites and the costs quickly add up.
Now imagine doing a single study that can be used at each site and saving money by buying disinfectant from a smaller number of companies.
“Through collaboration with BioPhorum on our disinfectant efficacy approach, we were able to realize cost savings of $1.59m for two disinfectant efficacy studies,” said Stephanie Ramsey, Principal Scientist, Global Microbiology at Takeda.
How are you doing your disinfectant efficacy studies?