Cordyceps freeze dryer manufacturers share the freeze dryer verification preparation points
First, the preparation of the Cordyceps freeze dryer verification program
The pre-validation of the production of Cordyceps freeze dryer includes: 1 confirmation of the public works required for the production of freeze-dried products and confirmation of the manufacturing environment, design confirmation of each freeze-drying machine (DQ; 2 installation confirmation (IQ); 3 confirmation of operating conditions (OQ) 4; Production Process and Product Performance Verification (PQ). At the same time, the detailed verification scheme also includes the operation methods of each verification test.
Freeze-dried powder injection As a typical dosage form for freeze-dried production of drugs, a complete freeze-dried powder injection process also includes many other types of general production processes for injection production, such as liquid preparation, filtration, filling, cleaning, Sterilization, packaging, etc., this article only discusses the special process of "freeze dryer and freeze-drying" in the production of freeze-dried drugs.
2. Confirmation of relevant technical documents for the verification of Cordyceps freeze dryer
1) The freeze dryer verification plan should also include standard operating procedures (sops), data collection, statistical processing methods, and a statistical table of records. The content relates to the test conditions and results after the installation of the equipment, the freezing speed under no-load or full-load conditions, the freezing limit temperature, the control accuracy of the shelf temperature, the internal pressure state of the drying box, the pressure control accuracy, the low pressure and sterilization Completely required conditions, etc.
2) A record related to changes in operating conditions or changes in control conditions in the verification shall be filed in accordance with the requirements of the verification documents.
The verification scheme is based on a thorough understanding of the pharmaceutical production process and a full understanding of the equipment manufacturing and installation conditions and operating principles, as well as a thorough understanding of the supporting public service facilities.
3) The verification file of the freeze-drying process shall include equipment installation, equipment working principle, operation and control system principle, control accuracy and detailed description of its auxiliary system.

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