TECHNIQUE DEVELOPMENT OF CLEANING VALIDATION FOR CHLORDIAZEPOXIDE IP TABLETS DOSAGE FORM

Abstract

Carefully designed cleaning validation and its evaluation can ensure that residues of active pharmaceutical ingredient will not carry over and cross-contaminate the subsequent product. Chemical 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. First all equipments, used in the production of chlordiazepoxide, were visually inspected for the cleanliness and were found visually clean. Chemical inspection was done on basis of 10 ppm criteria. Range of chemical residue was 1.48-9.89 ppm in dispensing booth, 0.31- 9.28 ppm in granulation room, 0.00 to 9.94 in sifter, 0.00 to 4.03 in sifter cum multimill, 0.00 to 7.01 in rapid mixer granulator, 2.48 to 8.06 in fluidized bed dryer, 0.00 to 8.01 in conta blender, 0.00 to 9.44 in compression cubicle and compression machine, 0.00 to 3.01 in coating room and coating machine and 0.00 to 9.85 in blister packing room and blister packing machine. Result indicated that calculated limit of chemical residue 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.