The following work aimed at validating the cleaning procedure of a vial filling machine. The machine was used for the dosing sterile powders of many products. It was necessary that it would clean efficiently between batches of the same product and between batches of different products. Ceftazidime pentahydrate was the product of choice as the worst case product for validating the cleaning procedure. A method was adopted for cleaning the machine using purified hot water. Visual examination and swab sampling were performed to ensure the absence of the active ingredient residues and micro-organisms. Rinse samples were also analyzed to ensure the validity of the cleaning procedure. Ceftazidime pentahydrate was analyzed using a reliable HPLC method of assay. Nonspecific methods for detecting residues in the final rinse as total organic carbon (TOC), conductivity and pH determination were employed. Results of sample analysis proved the validity of the cleaning procedure employed as no residues were detected and analysis results were all within the acceptance limits determined through calculations.
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