Using A Matrix Approach for the Cleaning Validation of Multi-Product Manufacturing Systems
Applying full cleaning validation for every product changeover on multi-product (non-dedicated) pharmaceutical manufacturing equipment can be very time consuming, expensive and pretty pointless, if you have a common cleaning procedure for all/groups of products. Applying a risk based matrix approach, where the cleaning process is validated for the most toxic and least soluble compound (marker compound), optimizes the cleaning validation process and also demonstrates that you understand your products, the residues they leave and the cleaning process itself (other factors such as the most difficult to clean, based on the nature of the residues remaining, may also be considerations).
This course covers: assessing your product mix and potential residues (before and after cleaning); applying a risk based approach to marker compound selection; applying limits for residues, determining the number of cleaning runs required and incorporation of clean and dirty hold times. Worked examples will be included.
The course is aimed at individuals involved directly or indirectly in establishing a matrix approach to cleaning validation. Target disciplines include validation, quality assurance, technical support and production (supervisors and management).
Presenter: Mike James