Water-bath type sterilizer temperature reduction control method

Abstract

The invention discloses a water-bath type sterilizer temperature reduction control method, which relates to the large volume parenteral industry. The water-bath type sterilizer temperature reduction control method comprises the step of pre-setting a sterilization temperature, a cooling temperature, a pressure parameter A, a pressure parameter B, a pressure parameter C, pressure control deviation parameters from C1 to C10, a stage temperature set value Tx1, and a stage temperature set value Tx2. In an initial stage from sterilization to cooling, a temperature T in a cabinet and pressure P in the cabinet are obtained, timing is started, a theoretical pressure value P1 is calculated by means of a formula P1=A*(T-B)+C, five corresponding pressure upper limits and five corresponding pressure lower limits are obtained according to the theoretical pressure value P1 and the pressure control deviation parameters from C1 to C10, and slow temperature reduction is started. Through rapid output ofpressure supplementation and pressure reduction devices, relatively constant pressure in the cabinet is realized, under this condition, a cooling given value is increased to realize rapid cooling at acooling high-temperature stage. After entering a cooling low-temperature stage, a cooling device is continuously and completely turned on, and the pressure in the cabinet is continuously reduced to be constant within a reasonable range. The water-bath type sterilizer temperature reduction control method shortens the temperature reduction time of a sterilized product, and reduces a cumulative F0 value in the sterilization process.

Description

technical field [0001] The embodiment of the present invention relates to the large transfusion industry, more specifically, the embodiment of the present invention relates to a temperature control method for the cooling process of a water bath sterilizer, especially for heat-sensitive medicines in the form of plastic bottles and stand-up pouches. Temperature and pressure control methods in the cooling stage of the sterilization process. Background technique [0002] Sterilization cabinet is the core equipment for aseptic guarantee in the production process of large infusion products. Water bath sterilization is mainly a system in which the heating medium (purified water) circulates in the sterilizer, and sprays product bottles and bags to transfer heat to the internal liquid medicine for sterilization. [0003] The F0 value is an important indicator that objectively reflects the sterilization effect during the sterilization process, and is also called the measurement value...

AI Technical Summary

Problems solved by technology

Disadvantages of this method: there is a long duration when the temperature of the liquid medicine is between the sterilization set temperature value and 100°C, and the risk of a high cumulative F0 value is not conducive to the quality control of thermally unstable products

[0006] The current patent does not involve the temperature and pressure control method of plastic bottles, stand-up pouches and other packaging products in the cooling stage of water bath sterilization

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