Equipment cleaning procedures should follow the following principles:
1. Clear washing method and cycle.
2. Define the cleaning and verification methods of key equipment.
3. Relevant data of cleaning process and inspection after cleaning shall be recorded and saved.
4. The cleaning of aseptic equipment, especially the parts and components that come into direct contact with drugs, must be sterilized, and the date of sterilization must be marked. If necessary, microbiological verification should be carried out.
Sterilized equipment should be used within three days.
5. Some movable equipment can be moved to the cleaning area for cleaning, disinfection and sterilization.
6. When the same equipment continuously processes the same sterile products, each batch shall be cleaned and sterilized;
When processing the same non-sterilized product in the same equipment, complete cleaning should be carried out at least three batches per week or per production.
Standard for purified water quality
Resistivity: acuity 0.5 M Ω. CM, conductivity: 2 or less mu S, ammonia acuities were 0.3 mu g/ml, nitrate mu g/ml, 0.06 or less heavy metal 0.5 mu g/ml or less