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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996
EISSN: 1596-9827
Vol. 15, No. 11, 2016, pp. 2329-2335
Bioline Code: pr16307
Full paper language: English
Document type: Research Article
Document available free of charge

Tropical Journal of Pharmaceutical Research, Vol. 15, No. 11, 2016, pp. 2329-2335

 en Studies on cleaning validation for a cream and ointment manufacturing line
Badawi, Aliaa A; Hegazy, Khaled & Louis, Dina

Abstract

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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