Cleaning Validation

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How to determine Product Contact Surface Area…

of RMG,Compression m/c, FBD,Tippler, Coating m/c (autocoater).


Prasad Aparajit

Dear Prasad Aparajit,

the Product Contact Surface Area is determined simply by measuring it. The dimensions of each piece of the equipment have to be measured and the the piece decomposed into geometrical shapes to calculate the surface. The sum of all of them will be the total Product Contact Surface Area. To calculate the accepted contamination levels only a rough calculation is needed, but to set the contamination levels for pieces that are sampled by rinsing of swabbed entirely you will need the exact surface of that piece. To define the Product Contact Surface you will have to preset selection criteria on whether to include the surface of a given component into the calculation, because there are surfaces which will be in constant product contact, others in occasional product contact, others in potential product contact, and others will have irreversible product contact (e.g. an aspiration hose, which is in intimate product contact, but where a return of a potential contaminant into the product batch is unlikely). If you are interested, contact me by mail and i can send you an example, because the size if the file exceeds the allowed attachment size.

Best regards