Context and challenges
This client is a company specialised in the development of X-Ray and MRI imaging solutions for diagnosing major diseases such as cancer, cardiovascular, inflammatory and neurodegenerative diseases.
For several years now, this client has undertaken a cleaning validation process. Following an observation made by Brazilian regulatory authorities, which are particularly stringent, this company sought to improve its cleaning validation process.
This client commissioned Assystem to conduct a diagnosis on the cleaning validation methodology implemented with respect to regulatory guidelines, and a state of the art of professional standards (strategic and practical approaches) for cleaning validation in general, and more specifically for implementation to their injectable production lines.
The diagnosis conducted covered the following items: justification of choice of contaminants, TOC (Total Organic Carbon) measurement versus specific method, rinsing water versus swabbing, calculation methods, expression of limits and specifications, sampling plans, and periodic validation.