Verify that the sterilization cabinet complies with GMP


In order to verify whether it meets the requirements of design and GMP, each sterilization cabinet should go through the verification procedure.

Generally speaking, the verification content of sterilization cabinet mainly includes three items: installation verification, operation verification and performance verification.

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1. Installation verification: mainly check that the installation of the sterilization cabinet meets the design requirements, and the relevant data and documents of the sterilizer meet the management requirements of GMP;

2. Operation verification: mainly check the performance of each unit of the sterilization cabinet and whether the whole machine operation meets the design requirements of the supplier;

3. Performance verification: mainly verify the heat distribution of different positions of the sterilization cabinet under the loading condition, and determine the location of the cold spot in the sterilizer;

Determine the parameters related to the product sterilization procedure, such as temperature, pressure and sterilization time, to ensure that the product sterilization reaches the microbial contamination rate below 10-6, and verify the reliability of the sterilization cabinet operation and the reproducibility of the sterilization procedure.

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The position within the autoclave steam sterilizer validation is variable.There is only one list of loads in SOP. During the test run, the verification run time shows positional equivalence by rotating different positions of the load. If after the above 3 verification runs prove the equivalence of the positions then you can stop.

The fixed load/variable position configuration gives the operator flexibility when operating the autoclave. This can save time for different types of heavy loads.


Variable load configuration means that different combinations of items and/or multiple items can be positioned in the chamber. The verification run must show that the cycle can satisfy two load configurations, and the small load test an item in the autoclave chamber, which must show that it is a difficult item to sterilize.

The control to be used in the selection of suitable liquid circulation control sterilized liquid depends on whether the load to be sterilized can pass the acceptance criteria. More than one liquid control is required to demonstrate that different types of bottles and liquids meet sterilization requirements.

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Our autoclave steam sterilizer is sterilized with computer and programmable logic controller (PLC) for automatic control, with clear human-machine interface and easy operation. The main parameters in the sterilization procedure, such as sterilization pressure, temperature, time, F0 value can be set according to the requirements of different products.

We offer more customized products, to learn more please click on our website.


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