Microbial Process Validation
Process validation contributes significantly in assuring pharmaceutical product and medical device quality throughout all stages of development, including that the drug or device is fit for its intended use. This involves documented scientific evidence that the process, from early design through end stage manufacturing and beyond, is capable of effectively and consistently delivering quality products or devices.
Process validation entails analysis of the raw materials used within the product or device during manufacture and that the manufacturing process follows all principles laid out by any relevant regulatory bodies.
From a microbiological perspective, conducting bioburden testing allows the manufacturer to determine if there are any problems within their processes and will allow them to take the relevant steps to ensure complete sterilisation of the product or device. During manufacturing, each step must be controlled in order for the end product to be considered to have met all quality attributes. 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.
Quality cannot simply be assumed on the basis of in-process or finished product inspection or testing, and control must be maintained throughout, hence the importance of considering process validation at an early stage in your development life cycle.
Please contact us directly to discuss your requirements for microbial process validation.