alexa Abstract | Cleaning validation Study for Common Equipments used in Paracetamol Suspension Pediatric 120mg/5ml and Simple Linctus BP


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Research Article Open Access

Abstract

The contamination of pharmaceutical product with other pharmaceutically active ingredients and microorganisms are the real concerned 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 Paracetamol Suspension Pediatric 120mg/5ml and Simple Linctus BP in a common facility, where Paracetamol and Simple Linctus could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity of Paracetamol and Simple Linctus. The instruments in the common facility were cleaned with purified water after production of Paracetamol 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 were below the acceptance criterial. Upon the compiled data, it was concluded that there were no cross contamination of Paracetamol and Simple Linctus to next product.

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Author(s): Ashish A. Gawai, Vinod S. Shinde, Swapnil V. Tejankar, Vinayak P. Mante, Umesh R. Khandagale, Suhit S. Bharad, K. R. Biyani

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