Studies on cleaning validation for a cream and ointment manufacturing line

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.

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Studies on cleaning validation for a cream and ointment manufacturing line
Aliaa A Badawi1, Khaled Hegazy2, Dina Louis1*
1Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, 2Central Administration of Pharmaceutical Affairs, Cairo, Egypt
*For correspondence: Email: dinalouis@hotmail.com, Dina.nassif@pharma.cu.edu.eg; Tel: 0202–0122 88 66 769
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