阅读说明：本技术 一种过氧化氢灭菌方法 (Hydrogen peroxide sterilization method ) 是由 王猛 常昊鹏 崔振伟 于 2021-09-02 设计创作，主要内容包括：本发明公开一种过氧化氢灭菌方法,先对灭菌容器干燥处理；向灭菌容器内加注汽化过氧化氢,实时检测汽化过氧化氢的浓度；汽化过氧化氢的浓度上升,当汽化过氧化氢的浓度达到起始灭菌浓度P-(L)时,起算灭菌时段；当汽化过氧化氢的浓度达到最高灭菌浓度P-(H)时,保持汽化过氧化氢的浓度恒定；不同的浓度条件下,汽化过氧化氢的灭菌效果不同,在灭菌时段内累计灭菌水平log值,灭菌水平log值为相应浓度条件下实际灭菌时间与单位灭菌时间的比值；当灭菌时段内灭菌水平log值的累计值达到灭菌完成值时,停止加注汽化过氧化氢,进行通风。本发明根据不同的灭菌浓度累计相应的灭菌程度,不需要浓度提升到最佳状态才开始计时,能够缩短灭菌的总时间,提升灭菌效率。(The invention discloses a hydrogen peroxide sterilization method, which comprises the steps of drying a sterilization container; injecting vaporized hydrogen peroxide into the sterilization container, and detecting the concentration of the vaporized hydrogen peroxide in real time; the concentration of vaporized hydrogen peroxide rises and reaches the initial sterilization concentration P L Calculating the sterilization time period; when the concentration of vaporized hydrogen peroxide reaches the maximum sterilization concentration P H While maintaining the concentration of vaporized hydrogen peroxide constant; under different concentration conditions, the vaporized hydrogen peroxide has different sterilization effects, and the log value of the sterilization level is accumulated in a sterilization time period and is the ratio of the actual sterilization time to the unit sterilization time under the corresponding concentration condition; and when the accumulated value of the log values of the sterilization levels in the sterilization period reaches a sterilization completion value, stopping filling vaporized hydrogen peroxide, and ventilating. The invention depends on different sterilization concentrationsCorresponding sterilization degree is accumulated, timing is started without increasing the concentration to the optimal state, the total sterilization time can be shortened, and the sterilization efficiency is improved.)

1. A method of hydrogen peroxide sterilization, comprising:

drying the sterilization container to enable the relative mixing humidity in the sterilization container to be reduced to a drying preset value, and stopping drying;

injecting vaporized hydrogen peroxide into the sterilization container to increase the concentration of the vaporized hydrogen peroxide, and detecting the concentration of the vaporized hydrogen peroxide in real time;

when the concentration of vaporized hydrogen peroxide reaches the initial sterilization concentration P_LCalculating the sterilization time period;

when the concentration of vaporized hydrogen peroxide reaches the maximum sterilization concentration P_HWhile maintaining the concentration of vaporized hydrogen peroxide constant;

accumulating log values of sterilization levels in a sterilization period, wherein the log values of the sterilization levels are the ratio of actual sterilization time to unit sterilization time under corresponding concentration conditions;

and when the accumulated value of the log values of the sterilization levels in the sterilization period reaches a sterilization completion value, stopping filling vaporized hydrogen peroxide, and performing a ventilation process.

2. The hydrogen peroxide sterilization method according to claim 1, wherein the sterilization completion value is an initial sterilization concentration P_LSix times the ratio of the corresponding actual sterilization time to the unit sterilization time.

3. The hydrogen peroxide sterilization method according to claim 2, wherein the aeration process comprises a first and a second downer, the aeration rate of the first downer being less than the aeration rate of the second downer.

4. The hydrogen peroxide sterilization method according to claim 3, wherein the initial sterilization concentration P is_L200-300 ppm, the maximum sterilization concentration P_H600-900 ppm, and the intermediate sterilization concentration P of the junction point of the first descending section and the second descending section_M400 to 600 ppm.

5. The method of claim 4, wherein vaporized hydrogen peroxide is injected into the sterilization container to the maximum sterilization concentration P_HThe gradient of the concentration value of vaporized hydrogen peroxide has previously decreased from a large value to a small value.

6. The hydrogen peroxide sterilization method according to any one of claims 1 to 5, wherein the humidity RS of the mixed gas in the sterilization container is monitored, and the sterilization process is stopped when the humidity RS of the mixed gas reaches a safe condensation value RSH.

7. The hydrogen peroxide sterilization method according to claim 6, wherein the condensation safety value RSH is 90-95%.

Technical Field

The invention relates to the technical field of medical production, and further relates to a hydrogen peroxide sterilization method.

Background

Vaporized Hydrogen Peroxide (VHP) is a technique that takes advantage of the fact that hydrogen peroxide has a better ability to kill bacterial spores at room temperature in a gaseous state than in a liquid state, and meets the requirement for complete sterilization. It is often used for sterilization of closed spaces such as clean rooms and sterile isolators. Vaporized hydrogen peroxide is a strong oxidizing agent that acts on the principle of dissociating highly reactive hydroxyl radicals through complex chemical reactions for attacking cellular components, including cell membrane, lipids, proteins and DNA. The Vaporized Hydrogen Peroxide (VHP) after the sterilization is completed is catalytically decomposed into water vapor and oxygen, and the environment is not polluted.

In the currently used hydrogen peroxide sterilization method, vaporized hydrogen peroxide is introduced into a sterilization container, the concentration of the vaporized hydrogen peroxide is detected, when the concentration of the vaporized hydrogen peroxide reaches a set sterilization concentration, the concentration is kept at the concentration, timing is started, ventilation is performed after a preset sterilization time period is finished, and sterilization is stopped.

The traditional sterilization process presets a sterilization time interval, cannot be adjusted according to a real-time sterilization state, and often causes low sterilization efficiency.

For those skilled in the art, how to improve the sterilization efficiency according to the real-time status is a technical problem to be solved at present.

Disclosure of Invention

The invention provides a hydrogen peroxide sterilization method, which accumulates the log value of sterilization level in a sterilization period and shortens the total sterilization time, and the specific scheme is as follows:

a hydrogen peroxide sterilization process comprising:

drying the sterilization container to enable the relative mixing humidity in the sterilization container to be reduced to a drying preset value, and stopping drying;

injecting vaporized hydrogen peroxide into the sterilization container to increase the concentration of the vaporized hydrogen peroxide, and detecting the concentration of the vaporized hydrogen peroxide in real time;

when the concentration of vaporized hydrogen peroxide reaches the initial sterilization concentration P_LCalculating the sterilization time period;

when the concentration of vaporized hydrogen peroxide reaches the maximum sterilization concentration P_HWhile keeping the concentration of vaporized hydrogen peroxide constant；

Accumulating log values of sterilization levels in a sterilization period, wherein the log values of the sterilization levels are the ratio of actual sterilization time to unit sterilization time under corresponding concentration conditions;

and when the accumulated value of the log values of the sterilization levels in the sterilization period reaches a sterilization completion value, stopping filling vaporized hydrogen peroxide, and performing a ventilation process.

Optionally, the sterilization completion value is an initial sterilization concentration P_LSix times the ratio of the corresponding actual sterilization time to the unit sterilization time.

Optionally, the ventilation process comprises a first and a second descent segment, the ventilation rate of the first descent segment being less than the ventilation rate of the second descent segment.

Optionally, the initial sterilization concentration P_L200-300 ppm, the maximum sterilization concentration P_H600-900 ppm, and the intermediate sterilization concentration P of the junction point of the first descending section and the second descending section_M400 to 600 ppm.

Optionally, the sterilization container is filled with vaporized hydrogen peroxide to the maximum sterilization concentration P_HThe gradient of the concentration value of vaporized hydrogen peroxide has previously decreased from a large value to a small value.

Optionally, the humidity RS of the mixed gas in the sterilization container is monitored, and the sterilization process is stopped when the humidity RS of the mixed gas reaches a safe condensation value RSH.

Optionally, the condensation safety value RSH is 90% to 95%.

The invention provides a hydrogen peroxide sterilization method, which comprises the steps of drying a sterilization container; injecting vaporized hydrogen peroxide into the sterilization container, and detecting the concentration of the vaporized hydrogen peroxide in real time; the concentration of vaporized hydrogen peroxide rises and reaches the initial sterilization concentration P_LCalculating the sterilization time period; when the concentration of vaporized hydrogen peroxide reaches the maximum sterilization concentration P_HWhile maintaining the concentration of vaporized hydrogen peroxide constant; under the condition of different concentrations, the vaporized hydrogen peroxide has different sterilization effects, and the log value of the sterilization level is accumulated in the sterilization period and isThe ratio of the actual sterilization time to the unit sterilization time under the corresponding concentration condition; and when the accumulated value of the log values of the sterilization levels in the sterilization period reaches a sterilization completion value, stopping filling vaporized hydrogen peroxide, and performing a ventilation process. According to the invention, corresponding sterilization degrees are accumulated according to different sterilization concentrations, and timing is started without increasing the concentration to an optimal state, so that the total sterilization time can be shortened, and the sterilization efficiency can be improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

Fig. 1 is a graph of a hydrogen peroxide sterilization process of the present invention.

Detailed Description

The core of the invention is to provide a hydrogen peroxide sterilization method, which accumulates the log value of the sterilization level in the sterilization period and shortens the total sterilization time.

In order to make the technical solution of the present invention better understood by those skilled in the art, the hydrogen peroxide sterilization method of the present invention will be described in detail with reference to the accompanying drawings and specific embodiments.

FIG. 1 is a graph of the hydrogen peroxide sterilization process of the present invention wherein the left vertical axis represents PPM, which is the concentration in parts per million of solute mass to total solution mass and for gases, PPM is typically either mole fraction or volume fraction. The right vertical axis represents RS, the relative mixed humidity, which is the ratio of the mixed absolute humidity of the humid air containing water vapor and hydrogen peroxide vapor to the maximum mixed absolute humidity that can be achieved at the same temperature. The horizontal axis represents time. The whole sterilization process comprises three stages of drying, sterilization and ventilation. Curve (r) represents the change of RS and curve (r) represents the change of PPM.

The hydrogen peroxide sterilization method comprises the following steps:

s1, drying the sterilization container to enable the relative mixing humidity in the sterilization container to be reduced to a preset drying value, and stopping drying; the sterile container is kept dry before the start of sterilization.

S2, filling vaporized hydrogen peroxide (H) into the sterilization container₂O₂) Increasing the concentration of the vaporized hydrogen peroxide, and detecting the concentration of the vaporized hydrogen peroxide in real time; after the vaporized hydrogen peroxide was introduced, the hydrogen peroxide concentration in the sterilization container rapidly increased from zero.

S3, when the concentration of vaporized hydrogen peroxide reaches the initial sterilization concentration P_LCalculating the sterilization time period; FIG. 1 shows the hydrogen peroxide concentration reaching the initial sterilization concentration P_LAt a time point of t_LFrom t_LThe calculation of the sterilization period is started.

S4, when the concentration of vaporized hydrogen peroxide reaches the maximum sterilization concentration P_HWhile maintaining the concentration of vaporized hydrogen peroxide constant; when the concentration of the vaporized hydrogen peroxide reaches the set maximum sterilization concentration P_HKeeping the concentration constant, without further increasing the concentration of vaporized hydrogen peroxide, FIG. 1 reaching the maximum sterilization concentration P_HAt a time point of t_H1Maximum sterilization concentration P_HThe end time point of the concentration is constant and is t_H2，t_H1To t_H2In between, the concentration of vaporized hydrogen peroxide is maintained at P_H。

S5, accumulating the log value of the sterilization level in the sterilization period, wherein the log value of the sterilization level is the ratio of the actual sterilization time to the unit sterilization time under the corresponding concentration condition; the sterilization time period is t_LTo t_H2The cumulative log of the sterilization levels corresponds to t_LTo t_H2And in the time period, the total area enclosed between the curve II and the abscissa.

S6, when the accumulated value of the log values of the sterilization levels in the sterilization period reaches the sterilization completion value, stopping filling vaporized hydrogen peroxide, and performing a ventilation process; also when t is_LTo t_H2Stopping the sterilization process and starting when the total area enclosed between the curve II and the abscissa reaches the sterilization completion value in a time periodVentilation is started.

The vaporized hydrogen peroxide has different concentrations and different sterilization effects per unit time, and the higher the concentration is, the better the sterilization effect per unit time is within a certain concentration range. The hydrogen peroxide sterilization method of the invention accumulates the corresponding sterilization degree according to different sterilization concentrations, namely, the concentration reaches P_LThe sterilization time is accumulated from time to time, and because the concentration is lower at the time, the sterilization effect is poorer in the same sterilization time, and because the log value of the sterilization level accumulated in unit time is less under low concentration; along with the continuous rising of concentration, the sterilization effect constantly promotes, and the sterilization level log value of unit interval accumulation constantly promotes. The present invention provides a sterilization method which does not require concentration elevation to an optimum state (P)_H) The timing is started until the concentration of vaporized hydrogen peroxide reaches P_HThe sterilization time period is calculated in the prior art, the total sterilization time can be shortened, and the sterilization efficiency is improved.

On the basis of the above scheme, the sterilization completion value set in the invention is the initial sterilization concentration P_LCorresponding to six times the ratio of the actual sterilization time to the unit sterilization time, i.e. if the concentration is kept at P_LConstant, obtaining the ratio of actual sterilization time to unit sterilization time, wherein six times of the ratio is t_LTo t_H2In the time period, the total area enclosed between the curve II and the horizontal coordinate; the area enclosed between the curve (II) and the abscissa is increased continuously along with the time of the sterilization period until t_H2At the point, the total area of the enclosure reaches the initial sterilization concentration P_LThe sterilization period can be stopped by six times the ratio of the corresponding actual sterilization time to the unit sterilization time.

And after the sterilization period is finished, starting a ventilation process, wherein the ventilation process comprises a first descending section and a second descending section, and the ventilation rate of the first descending section is less than that of the second descending section. As shown in fig. 1, the first descending section and the second descending section are both curves, the first descending section is a first stage of ventilation, the second descending section is a second stage of ventilation, during the first descending section, the descending rate of the concentration of vaporized hydrogen peroxide is slow, and during the second descending section, the descending rate of the concentration of vaporized hydrogen peroxide is fast. In the first descending process, the concentration of the vaporized hydrogen peroxide is still kept at a higher level, and the sterilization effect can still be achieved, so that the sterilization effect is ensured to be sufficient and effective.

Specifically, the initial sterilization concentration P in the present invention_L200-300 ppm, the highest sterilization concentration P_H600-900 ppm, and the intermediate sterilization concentration P of the junction point of the first descending section and the second descending section_M400 to 600 ppm; from the initial sterilization concentration P_LStarting to calculate the sterilization period when the concentration reaches P_HThe concentration is kept constant, and during the ventilation process, the concentration is reduced to the intermediate sterilization concentration P at the first reduction stage_MThe process still has a sterilizing effect, and the concentration rapidly drops to zero in the second descending section.

Specifically, vaporized hydrogen peroxide is injected into the sterilization container to reach the maximum sterilization concentration P_HThe gradient of the concentration value of vaporized hydrogen peroxide is decreased from large to small, i.e. t in FIG. 1_LTime of arrival t_H1In the time period, the rising rate of the concentration value of the vaporized hydrogen peroxide is gradually reduced, the rising rate is maximum in the initial stage and then gradually reduced, and the concentration reaches P_HIt will not rise any more and will be kept constant.

On the basis of any one of the technical schemes and the mutual combination thereof, the hydrogen peroxide sterilization method monitors the mixed gas humidity RS in the sterilization container in real time, and stops the sterilization process when the mixed gas humidity RS reaches the condensation safety value RSH; the invention utilizes the mixed gas humidity RS as the basis for judging whether condensation occurs, and when the actually measured RS value exceeds the set condensation safety value RSH, an alarm is given and the sterilization period is quitted to prevent the condensation from occurring.

Conventional judged condensation utilizes Relative Humidity (RH), which is the ratio of the absolute humidity of humid air to the maximum absolute humidity that can be achieved at the same temperature; absolute humidity is the mass of water vapor contained in per cubic meter of moist air, and is given in Kg/m³(ii) a Humid air refers to air that contains water vapor, but no hydrogen peroxide vapor. The RS value is used for replacing the original RH value, so that the condensation can be effectively avoided.

The set safe condensation value RSH can be 90% -95%, and the RH value is less than 100% to avoid condensation and keep a certain safety margin.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.