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Talking about lyophilizer system and instrument table related technical verification


Freeze dryer and chiller equipment are relatively close in some functions, but freeze dryer has the function of drying in addition to cooling, while freeze dryer is mainly composed of vacuum condenser, heat exchange system, refrigeration system, vacuum system, and instruments. Automatic control system device composition. Among them, detailed technical documents of equipment and instruments, parts and general assembly drawings, installation technical documents, and system commissioning methods and operating instructions recommended by equipment manufacturers are of great reference significance for the formulation and implementation of verification schemes. , This process should be archived and managed together with other verification technology files as part of the verification process. To ensure that the lyophilizer is very suitable for practical operation!

The composition of the lyophilizer system includes

I. Requirements for prior verification of public engineering systems used in freeze-drying processes
Other auxiliary systems related to the freeze-drying process often include supporting public systems such as nitrogen, cooling water, pharmaceutical water systems, compressed air, pure steam, and industrial steam. They have a great impact on the freeze-drying process, so they need to be based on freeze-drying. Confirm the specific requirements for drug production. It is important to confirm that the protection of the lyophilization process of the public engineering system is crucial. The technical documents of these systems and the relevant records obtained in the confirmation shall also be archived according to the verification requirements.
Although the accuracy of the measuring instrument has been considered in the design of the control system, in order to make the data obtained during the verification process accurate and reliable, the instrument must be calibrated before and after verification.

Requirements for previous verification of calibration and repair of measuring instruments
During the freeze-drying process, temperature and pressure parameters are constantly changing. The entire process of freeze-drying needs to effectively monitor these process parameters. Because the instrument has a measurement error, the error value is the measured value minus the true value, so the concept of accuracy is introduced in the use of the instrument. The measurement accuracy of the instrument is directly related to the reliability of the numerical values of temperature and pressure during the freeze-drying process. The temperature measurement element is a common component of freeze dryer instrumentation. Which temperature measurement element is used must be determined according to the scope of process monitoring and the measurement accuracy of the instrument.

Of course, the above introduction is not comprehensive enough. As a manufacturer and sales manufacturer of high-quality chiller, screw chiller , mold temperature machine and other equipment in Dongguan and China, Guansheng Machinery Co., Ltd.'s freeze dryer is also excellent. Sheng Machinery Company always insists that there is no best, only better concept, and it will continue to promote the continuous optimization of products and industries.



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