Hi all, I’m working on cleaning validation project and I need to know How can I choose specific detergent for familiar products? For example, When I must use an alkaline detergent or an acid detergent? considerations with some substances, etc.
I would appreciate some sources to find this information.
Thanks!
It depends on the drug product formulation! If the formulation is acidic you use an alkaline detergent and vice versa. In any case the proposed cleaning procedure must be confirmed with a study (usually disintegration coupons) and an analytical method that meets the requirements of ICH Q2.
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I have performed laboratory cleaning studies. You might use small “coupons” of material and baths with cleaning agents in the bath. You can put product on the coupons, let it dry, and then dip the coupons in the baths. Weighing the coupons before cleaning and then after cleaning (and drying) tells you how much product was cleaned off of the coupons. You can do this with varying concentrations and varying chemicals. Then select which chemical and which concentration you want to use.
Remember more chemical is not necessarily better, as you now have a cleaning chemical which must be washed off of the surfaces.
I know of a company which does this (I’m not affiliated with them nor do I get any kickback in any way for promoting them) which does this type of analysis. Please PM me if you want a contact.