Microbial Process Validation
Microbial process validation is documented scientific evidence that a process, from early design through end stage manufacturing and beyond, is capable of effectively and consistently delivering quality products or devices.
This validation is necessary to ensure that drugs and medical devices are fit for their intended use and follow the principles laid out by regulatory bodies for quality, safety and efficacy.
During manufacturing, each step must be controlled in order for the end product to be considered to have met all quality attributes and we are able to support process validation claims where microbiological evidence is required.
As an example, we have supported claims for proof of reduction of bioburden by providing an artificial bioburden (with or without simulated soiling). This enabled the client to investigate the processes designed for the reduction of bioburden and objectively qualify the efficacy and reproducibility of the process.
Please contact us directly to discuss your requirements for microbial process validation.