Tropical Journal of Pharmaceutical Research

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Studies on cleaning validation for a cream and ointment manufacturing line

Aliaa A. Badawi, Khaled Hegazy, Dina Louis


Purpose: To validate a new and simple method for cleaning a manufacturing line for creams and ointments.

Methods: The worst case product of the line chosen was a cream containing three practically insoluble ingredients: betamethasone, tolnaftate and cliquinol. The cleaning method utilized hot water and a commercial detergent, followed by rinsing. Validation methods included the visual inspection of the machine surface, swab sampling, microbial bioburden determination and testing the final rinse for conductivity, pH and total organic carbon (TOC) limits. Acceptance limit calculations depended on the figure tip unit (FTU).

Results: No visual residue or chemical residue was detected above 674.37 ppm, which is the maximum allowable carry-over level of the drug. Similarly, microbial bioburden was < 25 CFU/swab - the acceptable limit.

Conclusion: The method adopted to get rid of insoluble drug residue and microorganism from the cream and ointment production facility was successful. The method is simple and reproducible as indicated by the results of the three cleaning cycles.

Keywords: Validation, Worst case product, Swab sampling, Finger-tip unit, Acceptance limits, Cream and ointment manufacturing line
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