How to carry out the temperature verification of moist heat sterilizer?

Design requirements to start, evolved into the current domestic widely used moist-heat temperature verification of large volume injection experimental methods and experimental equipment, but also the basic requirements of temperature verification program design. The use of its functional test steps and reference equipment as follows: Prerequisites: wet heat sterilization equipment installation test qualified, the site and utility engineering external conditions are complete. That is usually said (DQ, IQ) has been the end of the position in the OQ run to confirm. Temperature validation program design basic requirements; the basic program design of the basic requirements of moist heat sterilization from the US. FDA in the mid-1970s, and in the 1980s the implementation of: "on the technical principles of large-volume injectable GMP" five aspects of the requirements: in the sterilization process should be able to ensure that the product meets the F0 ≥ 8; prior to sterilization Before sterilization, the container to be tested has the highest bacterial load, and the contaminating bacteria should have the strongest heat resistance; each sterilization kettle for each type of loading and each size of container validation experiments are at least 10 thermocouples for heat distribution experiments; the container to be tested is filled with products of similar viscosity for the heat penetration experiment to find out where the slowest point of warming is located in the container, and at least 10 containers are used, and each of them is added with the appropriate bio-indicator and inserted with thermocouples. At least 10 containers are used, each with appropriate biological indicators and thermocouples inserted. When the parameters of the sterilizing kettle have reached a reproducible state as confirmed by the heat distribution experiments and the temperature has reached the set sterilization temperature, the F0 ? value until cooling begins; temperature changes must be maintained within ±0.5°C from the time the product reaches sterilization temperature until cooling begins. Objective: To discuss the necessity of periodic temperature verification of pre-vacuum pressure sterilizers, and to help medical institutions to choose appropriate methods for temperature verification. Methods: The temperature performance requirements and validation methods of pre-vacuum sterilizers were given, and examples were analyzed. Results: The arrangement of test loads and temperature measurement points varied greatly when the volume of sterilization chambers was different. Conclusion: Based on the exclusion of factors affecting temperature performance, medical institutions should periodically verify the temperature of pre-vacuum sterilizers.