1, there is a clear washing method and washing cycle.
2, a clear method of cleaning and verification of key equipment.
3, the cleaning process and post-cleaning inspection of the relevant data should be recorded and saved.
4, the cleaning of aseptic equipment, especially the parts and components in direct contact with drugs must be sterilized and labeled with the date of sterilization, and microbiological validation, if necessary. Sterilized equipment should be used within three days.
5. Certain movable equipment may be moved to the cleaning area for cleaning, disinfection and sterilization.
6, the same equipment for continuous processing of the same sterile product, between each batch to be cleaned and sterilized, the same equipment for processing the same non-sterile product, at least weekly or after each production of three batches of comprehensive cleaning.