TECHNIQUE DEVELOPMENT OF CLEANING VALIDATION FOR CHLORDIAZEPOXIDE IP TABLETS DOSAGE FORM BY MICROBIOLOGICAL METHOD

Abstract

The amount or level of cleaning required in order to ensure that the API is free from unacceptable levels of contamination by previous substances varies depending on the step being cleaned and the next substance being manufactured in the same piece of equipment (train).Carefully designed cleaning validation and its evaluation is necessary to ensure that residues of active pharmaceutical ingredient will not carry over and cross-contaminate the subsequent product. Microbiological inspection method was developed and validated for the verification and determination of chlordiazepoxide in the production area and to confirm the efficiency of the cleaning procedure as per CGMP regulations. Microbiological inspection was done on basis of Total Bacterial Count (TBC) criteria. Microbiological acceptance criteria was that TBC should not be more than 30. Range of TBC was 1-24 in dispensing booth, 9 to 26 in granulation room, 8 to 23 in sifter, 5 to 15 in sifter cum multimill, 10 to 25 in rapid mixer granulator, 5 to 18 in fluidized bed dryer, 12 to 27 in conta blender, 2 to 27 in compression cubicle and compression machine, 3 to 26 in coating room and coating machine and 6 to 27 in blister packing room and blister packing machine. Result indicated that TBC value was not exceeded over prescribed limit during three consecutive batches of production after cleaning procedure. Hence, it can be said that this cleaning method validation on solid dosage forms of chlordiazepoxide can be used in routine cleaning to avoid the risk of cross contamination.