Accurate shape control method and device used after sterilization of infusion type products

A precise control and product technology, applied in temperature control, packaging sterilization, water supply equipment, etc., can solve the problems of difficult to maintain the appearance, increase product waste rate, etc., to reduce product waste rate, reduce the probability of scrapping, and reduce raw materials the wasteful effect of

Inactive Publication Date: 2019-11-12
SHINVA MEDICAL INSTR CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Along with the research and development of new drugs in pharmaceutical companies, new sterilization process requirements are constantly put forward, especially higher requirements for the heating and cooling rate and time of sterilizers. In addition, because the products produced by different pharmaceutical companies are The initial condition of the product is different, such as the material of the product, the filling temperature of the pharmaceutical industry, the content of air in the product, the thickness and uniformity of the product, the shape of the product itself, the external pressure during sterilization, and the way the product is placed during sterilization And other factors, it is difficult to maintain the appearance of the product after sterilization, because the appearance is damaged and the product is scrapped, which increases the reject rate of the product

Method used

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  • Accurate shape control method and device used after sterilization of infusion type products
  • Accurate shape control method and device used after sterilization of infusion type products
  • Accurate shape control method and device used after sterilization of infusion type products

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Experimental program
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Effect test

Embodiment 1

[0031] Such as figure 2 As shown, the precise control method of the shape of the transfusion product of the present invention after sterilization comprises the following steps:

[0032] (1) According to the characteristics of the product to be sterilized, divide the sterilization heating section and the sterilization cooling section into multiple subsections, for example, the sterilization heating section is divided into 12 subsections, and the sterilization cooling section is divided into 12 subsections;

[0033] (2) In the HMI system 5, correspondingly input the starting temperature T of each segment 初 and end temperature T 终 , set the starting pressure P 初 and end pressure P 终 , and then input the temperature rise rate △T in this temperature range. As the Tx temperature continues to rise, the pressure Px that needs to be added to the sterilized product will continue to increase. According to the relationship of a linear function, it can be obtained:

[0034]

[0035] ...

Embodiment 2

[0080] On the basis of Embodiment 1, in the unit time of N consecutive sections; the temperature sensor detects that the temperature change rate T per unit time is greater than the set temperature change rate ΔT, or the temperature sensor detects the temperature change rate per unit time T is less than the set temperature change rate △T; alarm reminder. 2≤N≤25. The value of N is set according to the required sterilization temperature change, that is, the accuracy of regulating the temperature change rate is determined. N can be 2, 3, 4, 5, 6, 10, 15, 20 or 25. Preferably, N is 5, 10 or 20.

[0081] Pressure sensor: refers to the device that uses a diaphragm device (stainless steel diaphragm, silicone diaphragm, etc.) as a medium to measure the pressure of gas and liquid with a pressure-sensitive element, and converts it into an electrical signal output.

[0082] Temperature sensor: refers to a sensor that can sense temperature changes and convert them into usable output sig...

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Abstract

The invention relates to an accurate shape control method and device used after sterilization of infusion type products and belongs to the technical field of medical equipment. The method comprises the steps as follows: (1) setting temperature and pressure of a sterilization heating stage and a sterilization cooling stage at stages; and (2) corresponding to each stage, setting initial temperatureT initial and final temperature T final, setting initial pressure P initial and final pressure P final, setting temperature change rate delta T and controlling temperature change, wherein the relationbetween the pressure PX and instant temperature TX required in the stage is shown in the description; and detecting actual pressure P actual in a cavity of a sterilizer and enabling P actual to approach PX by a pressure control method. By the aid of the sterilization heating stage and the sterilization cooling stage, the temperature change rate can be controlled accurately, the pressure can be adjusted accurately, pressure inside and outside a product can be kept balanced, and the good shape of the product can be kept.

Description

technical field [0001] The invention relates to a method and device for precisely controlling the shape of infusion products after sterilization, and belongs to the technical field of medical equipment. Background technique [0002] At present, there is a class of heat-sensitive drugs in injectable drugs. This type of drugs is different from normal saline with poor heat sensitivity. It is easy to reduce the efficacy of drugs in a high-temperature environment for a long time, which directly affects the medicinal value of drugs. This type of medicine has very strict requirements on the heating and cooling time, so the requirements can only be met by controlling the heating and cooling rate. With the release and implementation of the appendix "Computerized System" and "Confirmation and Verification" of "Good Manufacturing Practice for Drugs (Revised in 2010), the state's supervision of pharmaceutical companies is becoming more and more stringent, and pharmaceutical companies th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/24A61L2/04G05D23/20B65B55/14
CPCA61L2/0023A61L2/24A61L2202/14A61L2202/21B65B55/14G05D23/20
Inventor 白宝丹吴永广傅佩顺于钊赵鑫
Owner SHINVA MEDICAL INSTR CO LTD
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