Definitions and Descriptions of process.
Type A cleaning:
In a continuous production runs, when the cleaning is done in between the completion of a batch of a product and start up of subsequent batch of the same product, where the formulation and the API and process of manufacturing remains unchanged. Objective of type A cleaning is to clean equipment to provide clean equipment for subsequent production batch manufacturing in a clean condition. Also, the manufacturing and filling rooms being utilized must be cleaned completely first with wet mop and then with dry mop, area supply and return grills and filterers too are required to be cleaned with first with wet mop and then with dry mop. Finally, the floor is required to be cleaned with wet mop and dry mops. Followed by moping with disinfectant liquid as per the SOP for disinfection of floor in manufacturing filling and packing areas. In event of the same products production goes beyond the 5 days’ time span or after 10 batches of same product, Entire equipment’s and area is required to be subjected to type B cleaning.
Type B Cleaning:
Cleaning procedure is required to be adapted for changeover of production of one product to other product or after every five days of continuous production run, whichever is earlier. Cleaning must be done to eliminate previous product traces from inside and outside of the equipment from floor and from ancillary equipment’s, transfer pipes and equipment’s. This type of cleaning must ensure cleaning of AHU supply riser filters, return filters in order to remove complete traces of previous product. Cleaning is therefore required to be done with application of soap solution, and manual or mechanical scrubbing, final rinsing with purified water and drying in HEPA filtered air. Flooring is washed with soap solution and finally disinfected with disinfectant solution as per the SOP for disinfection of flooring, and coving. Finally test for absence of previous product traces is required to be done on the equipment surfaces where subsequent product is going to be manufactured.