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Abstract

Cleaning validation of Ibuprofen and Methocarbamol tablets

Contamination of pharmaceutical product with other pharmaceutically active ingredients and microorganisms are the real concern which questions the integrity and safety of the pharmaceutical product. In most cases contamination of pharmaceutical products occurs when a common facility is utilized to manufacture many products. Regulatory agencies established requirements for cleaning of such common instruments/ facility and validation of such process which is documented evidence with a high degree of assurance that one can consistently clean a system to predetermined and acceptable limits. Production of tablet with Ibuprofen 200 mg and Methocarbamol 500 mg in a common facility, where Ibuprofen and Methocarbamol could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity of Ibuprofen and Methocarbamol. The instruments in the common facility were cleaned with purified water after production of Ibuprofen 200 mg and Methocarbamol 500 mg and the validation of cleaning activity was done by visual inspection, swab sampling for chemical residue and swab sampling for microbiological analysis. The study result revealed the following (a) There were no visual residues on the equipments after cleaning, (b) Chemical residues were below the acceptance criteria, (c) Total aerobic microbial count, total combined molds and yeast count were below the acceptance criteria and (d) Pathogens were nil. Upon the compiled data, it was concluded that there were no cross contamina


Author(s): K. Kathiresan, Yellamula Prathyusha, C. Moorthi, N. Ahamed Dawood Sha, Kiran Krishnan, R. Manavalan

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