Can any one suggest me on my doubts.
We have started new manufacturing block. We have 10 products (A,B,C,D,E, F, G,H,I,J ) to manufacture this year. I want to do cleaning validation for this products. I did MAR calculation. I got 14ppm/swab (insoluble in water-worst case product) for product F. But there is no plan for 4 months for Product F. we have the plan for A,B,C products up to 4 months. Is it mandatory to show the swab results of F product to complete the cleaning validation? How can I conclude the report? How many batches swab reports shall I show?
Dear venkibt2005@gmail.com,
the worst case approach only uses the worst case in place of the other analytes. That means that until you manufacture your product F, the worst case is another, and as a matter of fact you should rank your entire product portfolio (A…J) from best case to worst case, and run a cleaning validation exercise whenever a worse case follows a better case in the production schedule, until completion of the three cleanings after the worst case of all (F), which i assume is close to impossible. In my opinion there are different ways to approach your situation: The best and obvious one is to run three cleanings after manufacturing product F. Second best is manufacturing one batch of F and running one cleaning validation exercise, which implies a cleanliness check with an non specific method (like TOC) at at least some sampling locations, after each other product cleaning until completion of the three validation runs with F. Third approach relies on the soundness of the cleaning method development, which should include some laboratory simulated cleaning of all the products with data to support the effectiveness of the cleaning method, and which gives some support to keep a “verification mode” until completion of the three runs with F. It is not clear if your acceptance limit (14 ppm/swab) is above or below the visually detectable level (approx. 1-4 µg/cm²), because ppm is a concentration unit but “/swab” does not say anything about the residue level on the equipment surface or in the next batch. If your accepted residue level is above the visually detectable limit it may be acceptable to rely on visual inspection until completion of the chemical cleaning validation.
Best regards
Alfred