Lucideon Validates the Efficacy of Sterilising Products
When manufacturing and processing sterile products in the healthcare industry, it is crucial that surfaces remain free of bacteria. This challenge is often made more difficult as different products are moving across surfaces of varying material and texture, and potentially being exposed to contamination along the way. It is crucial that appropriate cleaning and disinfection procedures are in place to ensure all surfaces remain pristine, and ultimately, the product remains sterile and effective.
The challenge
A global sterile product manufacturer approached Lucideon to assess and validate the effectiveness of various detergents, cleaning wipes and spray & wipe products in removing surface bacteria. The goal was to design a set of experiments that would enable a comparison of the effectiveness of each of the wipes and sprays, as well as validating their use against defined acceptance criteria, i.e. reduction in the bacteria present.
What we delivered
Using our internal knowledge, and guided by the various FDA guidance documents on cleanliness and disinfection, we developed a testing and validation strategy, along with the corresponding protocols. Our experts carried out a series of experiments in our GMP microbiology laboratories. Sterility was assessed by inoculating the samples with known bacterial strains, followed by simulated disinfection and quantification of the reduction in bacteria present. At the conclusion of the work, we provided the client with definitive conclusions regarding the effectiveness of the various disinfectant methods, as well as the validation behind those conclusions to immediately put the results to use on their manufacturing and processing lines.
Value to the client
Based on our efforts, a comprehensive and efficient strategy was implemented to both:
- Satisfy internal and external regulations and quality standards
- Validate their standard operating procedures for disinfection.
In addition, they are now equipped with a comprehensive baseline study to use in any root cause analyses in the future.