The concept and content of clean validation of high efficiency boiling dryer

The concept of clean verification of efficient boiling dryer
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 equipment 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. Clean validation is an important means of checking the effectiveness of cleaning measures.
Efficient boiling dryer cleaning verification content
Oral solid preparations for the production of direct contact with drugs such as granulator, 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 includes the following areas: cleaning range, object, responsible person, cleaning place, cleaning method, cleaning tools, cleaning agents and disinfectants (concentration), cleaning methods and cleaning water, equipment storage.
System Configuration of High Efficiency Boiling Dryer
1, the host system: filter room: with filter powder body, expansion room; drying room: cart; base: floating with a drainage mechanism; column: built-in air cable and rope.
2, the air heating system: the cabinet is 304 stainless steel; radiator: steam heating; steam valve: angle seat valve; radiator material: 1Cr18Ni9Ti.
3, air filtration system: early, medium efficiency, sub-efficient filter; screen, non-woven cotton, filter paper.
4, the discharge system: induced draft fan: frequency adjustment air volume; muffler; into the air duct;
5, the control system: button operating system PLC control procedures. A full set of equipment centralized control, the motor current, voltage and temperature are in the electronic control cabinet response and feedback. All low-voltage electrical appliances, pneumatic use of high-quality electrical components.