1. High efficient boiling dryer cleaning verification of the content
Oral solid preparations for the production of direct contact with the equipment such as granulator, efficient boiling dryer, tablet press, coating machines and other equipment after cleaning, cleaning and disinfection procedures are to be verified.
The basic contents of cleaning and verification of pharmaceutical production are pre-determined clean and disinfectant procedures, acceptable standards, selection of inspection methods, identification and re-verification of cleaning validity. The scope of cleaning of the efficient boiling dryer includes the following: clean range, object, responsible person, clean place, cleaning method, cleaning tool, cleaning agent and disinfectant (concentration), cleaning method and cleaning water, storage of equipment The
2. Clean the concept of validation
High efficiency boiling dryer cleaning verification is in the pharmaceutical production after the end of the pharmaceutical production enterprises to develop a clean disinfection procedures to confirm the process. From the equipment, especially from the efficient boiling dryer directly contact the surface of the drug, remove the visible and invisible residues, to prevent cross-contamination, so as to ensure the quality of drugs.
After cleaning the equipment, the residue, ie, the active ingredient, the cleaning agent (disinfectant), the microorganism and the like, are controlled within the acceptable standard, and the quality of the batch product will not be affected. Efficient boiling dryer cleaning validation is an important means of checking the effectiveness of cleaning measures.