WO2020052249A1 - 清洁作业区微生物控制***及其使用方法 - Google Patents

清洁作业区微生物控制***及其使用方法 Download PDF

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WO2020052249A1
WO2020052249A1 PCT/CN2019/086317 CN2019086317W WO2020052249A1 WO 2020052249 A1 WO2020052249 A1 WO 2020052249A1 CN 2019086317 W CN2019086317 W CN 2019086317W WO 2020052249 A1 WO2020052249 A1 WO 2020052249A1
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Prior art keywords
work area
clean
air conditioner
ozone
cleaning work
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PCT/CN2019/086317
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English (en)
French (fr)
Inventor
瞿瀚鹏
曹晟
王身健
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梁云
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    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
    • F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
    • F24F3/14—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by humidification; by dehumidification
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/202—Ozone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L9/00—Disinfection, sterilisation or deodorisation of air
    • A61L9/015—Disinfection, sterilisation or deodorisation of air using gaseous or vaporous substances, e.g. ozone
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F11/00—Control or safety arrangements
    • F24F11/89—Arrangement or mounting of control or safety devices
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F13/00—Details common to, or for air-conditioning, air-humidification, ventilation or use of air currents for screening
    • F24F13/28—Arrangement or mounting of filters
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
    • F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
    • F24F3/16—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by purification, e.g. by filtering; by sterilisation; by ozonisation
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F24—HEATING; RANGES; VENTILATING
    • F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
    • F24F8/00—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying
    • F24F8/20—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation
    • F24F8/24—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation using sterilising media
    • F24F8/26—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying by sterilisation using sterilising media using ozone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/25—Rooms in buildings, passenger compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2209/00—Aspects relating to disinfection, sterilisation or deodorisation of air
    • A61L2209/10—Apparatus features
    • A61L2209/11—Apparatus for controlling air treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2209/00—Aspects relating to disinfection, sterilisation or deodorisation of air
    • A61L2209/20—Method-related aspects
    • A61L2209/21—Use of chemical compounds for treating air or the like
    • A61L2209/212—Use of ozone, e.g. generated by UV radiation or electrical discharge
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/20—Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters

Definitions

  • the invention relates to the technical field of clean production, in particular to a microorganism control system in a cleaning operation area and a method for controlling microorganisms in a cleaning operation area.
  • the production area is classified into four levels: A, B, C, and D, and the requirements for microbial conditions in each level are specified.
  • the requirements of the corresponding sanitary conditions are shown in Table 1:
  • Table 1 Dynamic criteria for microbial monitoring in clean areas
  • the clean area required by the food and pharmaceutical industries has higher requirements for the control of microorganisms.
  • the growth and reproduction of microorganisms are related to the environmental humidity conditions and the water activity of the products. Based on this, the control of environmental microorganisms in clean production areas needs to control the environmental humidity and provide clean air to maintain the microbial environment in clean production areas.
  • the most classic environmental microorganism control method is fumigation, that is, fumigation with potassium permanganate and formaldehyde. After mixing potassium permanganate and formaldehyde, formaldehyde is rapidly volatilized by the strong oxidant potassium permanganate to generate formaldehyde vapor. To kill pathogenic microorganisms in the environment. However, formaldehyde has carcinogenic toxicity, so this method was later replaced.
  • the chlorine dioxide fumigation method the strong oxidizing properties of chlorine dioxide are used to disinfect the environment. However, it is easy to produce hypochlorous acid when it encounters water, and then it will decompose to produce residual chlorine, which will pollute products and the environment, and its use environment is gradually limited.
  • peroxyacetic acid fumigation method A liquid (glacial acetic acid, concentrated sulfuric acid) and B liquid (peroxyacetic acid) are mixed and activated, and then poured into a container at various points in a clean production area, and heated and gasified to disinfect the environment.
  • Peroxyacetic acid has strong oxidizing property and strong disinfection ability, but has strong corrosiveness to equipment and facilities, and has a relatively limited use environment.
  • Hu Chuanhong and others proposed a class I clean operating room disinfection method (application publication number CN107198784A), spraying the floor and walls of the operating room with ethanol first, and then drying with ozone-containing nitrogen for initial disinfection; Secondary disinfection is performed with a special disinfectant containing chlorine dioxide and sodium trichloroisocyanurate; and the disinfection method with ultraviolet sterilization lamp irradiation can meet the requirements of Class I clean operating room.
  • This method not only has complicated procedures, but also uses traditional disinfectants such as chlorine dioxide, which will leave residual chlorine in the production environment and cannot be used in production environments that require high levels of residual chlorine.
  • the "sedimentation bacteria in the cleaning work area” is detected by a naked dish, and the "air sampler” is used to sample and the “plate counting” method is used to detect the “in the cleaning work area”.
  • the number of "plankton” was evaluated by the two indicators “sedimentation bacteria” and “plankton” in the cleaning operation area.
  • this method is a lagging verification and evaluation method. Because “bare dish detection” and “plate counting” require microbial culture, and microbial culture takes a long time, this has caused production to have started or ended Only in production can we get the guidance on whether the environmental microbial control at the time of production meets the production requirements, and whether the environmental microbial conditions can meet the production requirements in a timely manner. Once the environmental factors change slightly, or the human operation deviates, it will bring great risks to production.
  • the purpose of the present invention is to overcome the problems caused by the disinfectants in the prior art and the problem of poor "static disinfection" disinfection effect, and to provide a micro-organism control system in a clean operation area, which is accessed through the ozone generator's air outlet duct through a ozone generator. Ozone.
  • the ozone concentration monitor monitors the ozone concentration in the working area, and the controller controls the operation of the system. It has the advantages of good disinfection and convenient use.
  • the invention also provides a method for controlling microorganisms in a cleaning work area.
  • the method uses ozone (O 3 ) with strong oxidizing power and strong penetrating power to dynamically disinfect environmental equipment and facilities, and the air has a good disinfecting effect, and ozone is easy Decomposition will not produce residues and will not adversely affect equipment and facilities.
  • CT value product of ozone concentration and time
  • ozone is used for environmental disinfection and sterilization. Its concentration and action time are two parameters to ensure the disinfection effect. The concentration and action time of different disinfection objects are different. To explore and summarize the range of CT values effective in disinfection of the cleaning work area.
  • the inventors used the method of "enterophilic bacteria verification" to establish the effective CT value of sterilization: the enteric bacteria were inserted into the aseptically treated BPW bacteria growth medium at 36 ° C Incubate in a constant temperature incubator of ⁇ 1 for 24-48 hours, then count using a blood cell counting plate to determine the concentration of Enterobacter in the culture medium, and then spread the bacterial solution evenly on the aluminum foil bag for testing in a sterile room.
  • the present invention provides a microorganism control system for a clean operation area, which includes a clean air conditioner, an ozone generator, an ozone concentration detector, and a controller.
  • the clean air conditioner has functions of dehumidification and heat preservation and fresh air supplement; the output pipe of the ozone generator is connected to the air outlet pipe of the clean air conditioner; the ozone concentration detector is arranged in a work area of a clean work area; the controller Signal connection with the clean air conditioner, ozone generator and ozone concentration detector respectively.
  • a plurality of the ozone concentration detectors are provided and distributed in different working areas of the cleaning working area.
  • the ozone concentration detector is provided with a remote transmission device, and is connected to the controller signal via the remote transmission device; the controller is a PLC.
  • the microbe control system of the cleaning work area of the present invention further comprises a host computer, the controller is provided with a host computer interface, and is connected to the host computer by signals.
  • the clean air conditioner includes a fresh air inlet, a return air outlet, a fan, a medium-efficiency filter, a temperature adjustment unit, a humidity adjustment unit, a high-efficiency filter, and an air outlet; the fresh air inlet and the return air outlet are connected to the fan Under the action of the fan, air passes through the intermediate efficiency filter, the temperature adjustment unit, the humidity adjustment unit, and the high-efficiency filter in order, and is discharged through the air outlet.
  • the invention also provides a method for controlling microorganisms in a cleaning work area, including the following steps:
  • Fresh air supplementation can quickly reduce the ozone concentration in the cleaning operation area, and a relatively low temperature and low humidity environment can inhibit the growth of microorganisms.
  • the ozone concentration in the cleaning work area is maintained at 30 ppm.
  • step 1) the product of ozone concentration and duration (CT value) is used to monitor and evaluate the actual disinfection effect in real time, and the product of ozone concentration and duration is controlled to 9000-14400 mg / m 3 min.
  • CT value the product of ozone concentration and duration
  • the cleaning work area is a cleaning work area for food, health food or pharmaceutical production.
  • the microorganism control system of the cleaning work area of the present invention not only realizes the dynamic disinfection process, but also achieves comprehensive disinfection of air filters, air-conditioning pipes, and equipment. Moreover, the disinfection effect using ozone disinfection is good, and it is effective for equipment and facilities. No damage and no environmental residues left.
  • the method for controlling microorganisms in a cleaning work area according to the present invention can ensure the ozone concentration and disinfection time in different work areas of the cleaning work area; monitor the disinfection effect of each work area in real time through CT values, and monitor and adjust the disinfection status of the cleaning work area in real time.
  • the ozone concentration can be quickly reduced while maintaining cleanliness, which is convenient for workers to enter; the constant temperature and low humidity environment can control the growth of microorganisms, which is beneficial to maintaining the cleanliness of the cleaning operation area.
  • FIG. 1 is a schematic diagram of a microorganism control system in a cleaning work area according to the present invention
  • FIG. 2 is a CT image of the method for controlling microorganisms in a cleaning work area according to the present invention.
  • Production area packaging area: 62 packaging area
  • the microorganism control system of the cleaning work area of the present invention includes a clean air conditioner 1, an ozone generator 2, an ozone concentration detector 4, a controller 3, and a host computer 5.
  • the clean air conditioner 1 includes a fresh air inlet 11, a return air outlet 12, a fan 13, a medium-efficiency filter 14, a temperature adjustment unit 15, a humidity adjustment unit 16, a high-efficiency filter 17, and an air outlet 18.
  • the fresh air inlet 11 is provided with an initial-effect filter, which is connected to the fan 13 together with the return air inlet 12, and the air passes through the intermediate-effect filter 14, the temperature adjustment unit 15, the humidity adjustment unit 16, and the high-efficiency filter 17 in this order.
  • the air outlet 18 is discharged.
  • the air outlet 18 is connected to the cleaning work area 6 through an air outlet pipe 7, which includes a production area 61, a packaging area 62, and a material storage area 63.
  • the air outlet pipe 7 is connected to the production area 61, the packaging area 62, and the material storage, respectively.
  • the area 63, the production area 61, the packaging area 62 and the material storage area 63 are connected to the return air outlet 12 through return air ducts, respectively.
  • the output pipe of the ozone generator 2 is connected to the air outlet pipe 7, and the generated ozone enters the production area 61, the packaging area 62, and the material storage area 63 for disinfection through the air outlet pipe 7; the production area 61, the packaging area 62, and the material storage area
  • the return air duct 8 in 63 is connected to the return air port 12.
  • An ozone concentration detector 4 is placed in the production area 61, the packaging area 62 and the material storage area 63 away from the air inlet.
  • the ozone concentration detector 4 uses a Swiss-made detector model MOT500-O3, which has a remote transmission.
  • the device is used to detect the ozone concentration in the production area 61, the packaging area 62 and the material storage area 63, and transmits it to the controller 3 through a remote transmission device.
  • the controller 3 uses the Siemens S7 200 PLC and communicates with the host computer of the S7 200 Host computer communication connection, the host computer uses Dell industrial computer.
  • the controller 3 is also signal-connected to the clean air conditioner 1 and the ozone generator 2, respectively, to control the working states of the clean air conditioner 1 and the ozone generator 2.
  • ozone production amount Q (mg / h) disinfection concentration (mg / m 3 ) ⁇ (workshop volume (m 3 ) + fresh air supplement Volume (m 3 )) ⁇ ozone attenuation coefficient S (0.428), so as to choose a suitable ozone generator.
  • the working process of the microorganism control system in the cleaning work area of the present invention is as follows:
  • the controller 3 controls the clean air conditioner 1 to close the fresh air inlet 11 and perform indoor air circulation through the return air outlet 12.
  • the indoor air enters the air return port 12 under the action of the fan 13, and is filtered by the medium-efficiency filter 14 to remove small dust in the air.
  • the humidity adjustment unit 16 adjusts the humidity of the air to a set humidity; removes minute dust, bacteria, spores and the like through the high-efficiency filter 17; and enters the air outlet duct 7 through the air outlet 18.
  • the controller 3 turns on the ozone generator 2 and sends ozone into the air outlet duct 7.
  • the ozone-containing air enters the three operation areas of the cleaning operation area 6 through the air outlet pipe 7: the production area 61, the packaging area 62, and the material storage area 63, and the equipment in the production area 61, the packaging area 62, and the material storage area 63.
  • the air is sterilized, and the air in the production area 61, the packaging area 62, and the material storage area 63 is circulated through the return air duct 8.
  • the ozone concentration detector 4 in the production area 61, the packaging area 62, and the material storage area 63 detects the ozone concentration in the production area 61, the packaging area 62, and the material storage area 63, and transmits the data to the controller 3;
  • the controller 3 transmits various data information to the upper computer 5, and the upper computer 5 generates concentration time charts (as shown in FIG. 2) and CT values of each working area for production technology and management personnel to monitor the disinfection status.
  • the controller 3 adjusts the amount of ozone generated by the ozone generator 2 according to the set concentration and the detected ozone concentration in each working area to control the ozone concentration in each working area, and the ozone concentration in the working area reaches the set value Start to calculate the disinfection time and CT value.
  • the CT value of each working area reaches the set value, the ozone generator 2 is turned off, the fresh air inlet 11 is opened, and the microbe control system in the cleaning working area exits the disinfection mode and enters the maintenance mode.
  • the fresh air inlet 11 is opened, and the clean air conditioner 1 replenishes the fresh air through the fresh air inlet 11 through the fresh air inlet 11 while returning the air through the return air outlet 12 to adjust the temperature and humidity in the clean air conditioner 1 and pass the intermediate efficiency.
  • the constant-temperature and constant-humidity clean air enters the air outlet pipe 7 through the air outlet 18, and enters the cleaning work area 6 through the air outlet pipe 7, the ozone concentration of the cleaning work area 6 decreases rapidly, and the sterility is maintained.
  • the air pressure in the cleaning work area 6 is in a positive pressure state. Part of the air enters the return air outlet 12 of the clean air conditioner through the return air duct 8 to circulate, and part of the air escapes from the cleaning work area 6.
  • the positive air pressure state of the cleaning work area 6 helps maintain the cleanliness of the cleaning work area 6.
  • microorganisms control system in the cleaning work area adopts the specific implementation manners given in the above embodiments.
  • the temperature of the cleaning work area is controlled at 25 ° C and the relative humidity is controlled at 30%.
  • the temperature of the cleaning work area is controlled at 30 ° C and the relative humidity is controlled at 65%.
  • the airborne plankton is detected according to the national standard method, and the surface of the equipment is wiped to detect the surface microorganisms.
  • Table 2 Test results of air microbial indicators in clean operation areas
  • the method for controlling microorganisms in a cleaning work area of the present invention has more obvious effects of disinfecting and inhibiting the growth of microorganisms.
  • the method for controlling microorganisms in a cleaning work area of the present invention can be applied to the control of environmental microorganisms in a cleaning work area in the field of food, health product or pharmaceutical production.

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  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Combustion & Propulsion (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Disinfection, Sterilisation Or Deodorisation Of Air (AREA)

Abstract

一种清洁作业区微生物控制***及其使用方法，该***包括洁净空调(1)、臭氧发生器(2)、臭氧浓度检测仪(4)和控制器(3)；洁净空调(1)具有除湿保温和新风补充功能；臭氧发生器(2)的输出管连接到洁净空调(1)的出风管道(7)；多个臭氧浓度检测仪(4)设置在清洁作业区(6)的不同作业区域；控制器(3)分别与洁净空调(1)、臭氧发生器(2)和臭氧浓度检测仪(4)信号连接，该使用方法通过洁净空调(1)的出风管道(7)将臭氧经循环风不间断送入清洁作业区(6)进行消毒，该控制***和使用方法实现了全面动态消毒，实时监控和调整各个作业区域的消毒效果。

Description

清洁作业区微生物控制***及其使用方法 技术领域
本发明涉及清洁生产技术领域，具体涉及一种清洁作业区微生物控制***和一种控制清洁作业区微生物的方法。
背景技术
GB14881-2013《食品生产通用卫生规范》中，基于食品质量与安全，对食品生产环境予以了规范要求，将食品生产区域分为“清洁作业区”、“准清洁作业区”、“一般作业区”，并对各类作业区域的微生物条件予以明确的规范要求。
GMP2010版中，基于药品特性，对生产区域进行了分级，分为A、B、C、D四个等级，并明确各个级别中微生物条件要求。相应等级的卫生条件要求见表1：
表1：洁净区微生物监控的动态标准
Figure PCTCN2019086317-appb-000001
食品、药品工业所要求的洁净区，对微生物的控制有较高的要求。微生物的生长繁殖，与环境的湿度条件、产品的水分活性有关；基于此，洁净生产区域的环境微生物的控制，需要从控制环境湿度、提供洁净空气来保持洁净生产区域的微生物环境。
最经典的环境微生物控制方式是采用熏蒸的方式，即用高锰酸钾、甲醛熏蒸，高锰酸钾与甲醛混合后，甲醛在强氧化剂高锰酸钾的作用下，快速挥发，产生甲醛蒸汽，以此来杀灭环境中病原微生物。但甲醛具有致癌的毒性，所以后来该方法被替代。还有二氧化氯熏蒸法：利用二氧化氯的强氧化特性，来对环境进行消毒。但其遇水易产生次氯酸，进而分解产生氯的残留，污染产品与环境，其使用环境逐渐受到局限。也有过氧乙酸熏蒸法：将A液(冰醋酸、浓硫酸)与B液(过氧乙酸)混合后活化，然后倒入洁净生产区域的各个点位的容器中，加热气化对环境消毒。过氧乙酸具有强氧化性，消毒能力强，但对设备设施具有强腐蚀性，使用环境有较大的局限性。
2017年5月，胡传红等人提出了一种Ⅰ级清洁手术室消毒方法(申请公布号CN 107198784A)，先对手术室内地面和墙壁喷洒乙醇，再用含有臭氧的氮气吹干进行初次消毒；再用含二氧化氯、三氯异氰尿酸钠的专用消毒剂进行二次消毒；再用紫外线灭菌灯照射的消毒方法，能达到Ⅰ级洁净手术室的要求。该方法不仅程序复杂，而且也使用了二氧化氯等传统消毒剂，会在生产环境留下残氯，不能用于对残氯要求高的生产环境。
而且所有这些消毒方法，均为一个“静态消毒”的方法，也就是要求在消毒过程中保持清洁区(洁净区)内的空气不流动，以便消毒灭菌剂蒸发产生的气体在整个区间逸散弥漫，对区间内的细菌、病毒进行杀灭。这就导致了消毒剂不能进入空气过滤器、设备内部的狭小空间及空调的进风、回风管道杀灭微生物。影响了消毒的效果。
通常情况下，对于清洁作业区的微生物控制的效果，通过裸碟检测“清洁作业区中沉降菌”，同时利用“空气取样器”取样，用“平皿计数”的方法来检测清洁作业区中“浮游菌”的数量，用“沉降菌”、“浮游菌”两个指标来评价清洁作业区的微生物控制情况。
但是，这种方法是一种滞后的验证、评价方法，由于“裸碟检测”和“平 皿计数”需要进行微生物培养，而微生物培养需要的时间很长，这就导致生产已经开始、或已经结束生产，才能得到生产时的环境微生物控制是否符合生产要求，不能及时得到环境微生物条件是否满足生产要求的指导意见。一旦环境因素稍有改变，或人的操作出现偏差，将给生产带来很大的风险。
发明内容
本发明的目的是为了克服现有技术消毒剂产生不良后果，“静态消毒”消毒效果较差的问题，提供一种清洁作业区微生物控制***，通过臭氧发生器在洁净空调的出风管道通入臭氧，通过臭氧浓度检测仪监控作业区域臭氧的浓度，通过控制器控制***的运行，具有消毒效果好，使用方便等优点。本发明还提供了一种控制清洁作业区微生物的方法，该方法利用氧化力强、穿透力强的臭氧(O 3)对环境设备设施、空气进行动态的消毒,消毒效果好，且臭氧易于分解，不会产生残留物，也不会对设备设施产生不良影响。还可通过臭氧浓度与时间的乘积(CT值)来实时评估消毒效果。
CT值监控消毒效果的方法：臭氧用于环境消毒灭菌，其浓度、作用时间是确保消毒效果的两个参数，而不同的消毒对象所需要的浓度、作用时间不同，发明人通过大量的试验，摸索、总结出清洁作业区消毒时有效作用的CT值范围。
为验证该值的有效性，本发明人采用“肠杆菌增菌验证”的方法，来确立消毒的有效CT值：将肠杆菌接入无菌处理后的BPW增菌培养基中，在36℃±1的恒温培养箱中培养24-48小时，然后采用血球计数板计数，以确定培养基中肠杆菌的浓度，再将该菌液在无菌室中均匀涂抹在测试用的铝箔袋上，然后将涂有菌液的铝箔袋放入测试箱中，分别用10ppm的臭氧消毒0.5小时、1小时、2小时、3小时、4小时；20ppm的臭氧消毒0.5小时、1小时、2小时、3小时、4小时和用30ppm臭氧消毒0.5小时、1小时、2小时、 3小时、4小时进行消毒处理，处理结束后采用表面擦拭的方法检测肠杆菌的致死率，以确定各种CT值下臭氧的消毒效果，由此得到本专利方法所需的CT值。
为了实现上述目的，本发明提供了一种清洁作业区微生物控制***，包括洁净空调、臭氧发生器、臭氧浓度检测仪和控制器。所述洁净空调具有除湿保温和新风补充功能；所述臭氧发生器的输出管连接到所述洁净空调的出风管道；所述臭氧浓度检测仪设置在清洁作业区的作业区域；所述控制器分别与所述洁净空调、臭氧发生器和臭氧浓度检测仪信号连接。
优选地，所述臭氧浓度检测仪设置有多个，分布在清洁作业区的不同作业区域。
优选地，所述臭氧浓度检测仪带有远传装置，并通过远传装置与所述控制器信号连接；所述控制器为PLC。
优选地，本发明的清洁作业区微生物控制***还包括上位机，所述控制器带有上位机接口，与所述上位机信号连接。
优选地，所述洁净空调包括新风入口、回风口、风机、中效过滤器、温度调节单元、湿度调节单元、高效过滤器和出风口；所述新风入口和所述回风口连通到所述风机，空气在所述风机的作用下依次通过所述中效过滤器、所述温度调节单元、所述湿度调节单元和所述高效过滤器，通过所述出风口排出。
本发明还提供了一种控制清洁作业区微生物的方法，包括以下步骤：
1)关闭所述洁净空调的新风补充功能，通过所述出风管道将臭氧经循环风不间断送入所述清洁作业区进行消毒，保持所述清洁作业区的臭氧浓度在不低于10ppm，时间不短于0.5小时；
2)开启所述洁净空调的新风补充功能，向所述清洁作业区送入经所述洁净空调处理的包含新风的清洁空气，并且将所述清洁作业区的温度维持在 ≤30℃、相对湿度维持在≤65％。补充新风可快速降低所述清洁作业区内臭氧的浓度，相对低温、低湿的环境可抑制微生物的增长。
优选地，在所述步骤1)中，保持所述清洁作业区的臭氧浓度为30ppm。
优选地，在所述步骤1)中，通过臭氧浓度与持续时间的乘积(CT值)来实时监控、评估实际消毒效果，将臭氧浓度与持续时间的乘积控制在9000-14400mg/m 3min。
优选地，所述清洁作业区为用于食品、保健品或药品生产的清洁作业区。
通过上述技术方案，本发明的清洁作业区微生物控制***，不仅实现了动态消毒的过程，可对空气过滤器、空调管道及设备内部实现全面消毒，而且使用臭氧消毒的消毒效果好，对设备设施无损伤，也不会留下任何环境残留。本发明的控制清洁作业区微生物的方法，能保证清洁作业区不同作业区域的臭氧浓度和消毒时间；通过CT值实时监控各个作业区域的消毒效果，能够实时监控和调整清洁作业区的消毒情况，保证消毒效果；消毒结束后能够在保持清洁度的情况下快速降低臭氧浓度，便于工作人员进入；恒温低湿的环境能够控制微生物的生长，利于保持清洁作业区的清洁度。
附图说明
图1是本发明的清洁作业区微生物控制***示意图；
图2是本发明的控制清洁作业区微生物的方法的一个CT图。
附图标记说明
1       洁净空调               2      臭氧发生
3       控制器                 4      臭氧浓度检测仪
5       上位机                 6      清洁作业区
7       出风管道               8      回风管道
11      新风入口                12     回风口
13      风机                    14     中效过滤器
15      温度调节单元            16     湿度调节单元
17      高效过滤器              18     出风口
61      生产区                  62     包装区
63      物料存放区
具体实施方式
以下结合附图对本发明的具体实施方式进行详细地说明，应当理解的是，此处所描述的具体实施方式仅用于说明和解释本发明，本发明的保护范围并不局限于下述的具体实施方式。
本发明的清洁作业区微生物控制***如图1所示，包括洁净空调1、臭氧发生器2、臭氧浓度检测仪4、控制器3和上位机5。
洁净空调1包括新风入口11、回风口12、风机13、中效过滤器14、温度调节单元15、湿度调节单元16、高效过滤器17和出风口18。新风入口11带有初效过滤器，与回风口12一起连通到风机13，空气在风机13的作用下依次通过中效过滤器14、温度调节单元15、湿度调节单元16和高效过滤器17通过出风口18排出。出风口18通过出风管道7连接到清洁作业区6，清洁作业区6包括生产区61、包装区62和物料存放区63，出风管道7分别连接到生产区61、包装区62和物料存放区63，生产区61、包装区62和物料存放区63分别通过回风管道连接到回风口12。臭氧发生器2的输出管连接到出风管道7，所产生的臭氧通过出风管道7进入生产区61、包装区62和物料存放区63进行消毒；生产区61、包装区62和物料存放区63中的通过回风管道8连接到回风口12。在生产区61、包装区62和物料存放区63的远离进风口部位均放置有臭氧浓度检测仪4，臭氧浓度检测仪4采用瑞士 生产的型号为MOT500-O3的检测仪，其带有远传装置，用来检测生产区61、包装区62和物料存放区63的臭氧浓度，并通过远传装置传送到控制器3，控制器3采用西门子公司的S7 200PLC，通过S7 200的上位机接口与上位机通讯连接，上位机采用戴尔工控机。控制器3还分别与洁净空调1和臭氧发生器2信号连接，控制洁净空调1和臭氧发生器2的工作状态。
在本发明的清洁作业区微生物控制***使用的臭氧发生器的选型标准为：臭氧产生量Q(mg/h)＝消毒浓度(mg/m 3)×(车间体积(m 3)+新风补充体积(m 3))÷臭氧衰减系数S(0.428)，以此来选择合适的臭氧发生器。MOT500-O3臭氧浓度检测仪的量程：0-100ppm。
在本发明的清洁作业区微生物控制***的工作过程如下：
在消毒模式下，控制器3控制洁净空调1关闭新风入口11，通过回风口12进行室内空气循环。室内空气在风机13的作用下，进入回风口12，通过中效过滤器14的过滤，除去空气中的较小灰尘；进入温度调节单元15，温度调节单元15将气温调节到设定温度；通过湿度调节单元16将空气湿度调节到设定的湿度；通过高效过滤器17除去微小的灰尘、细菌和芽胞等；通过出风口18进入出风管道7。同时控制器3打开臭氧发生器2，向出风管道7内送入臭氧。含有臭氧的空气通过出风管道7分别进入清洁作业区6的三个作业区域：生产区61、包装区62和物料存放区63，对生产区61、包装区62和物料存放区63中的设备和空气进行消毒，生产区61、包装区62和物料存放区63中的空气通过回风管道8进行循环。同时，生产区61、包装区62和物料存放区63中的臭氧浓度检测仪4分别检测生产区61、包装区62和物料存放区63中的臭氧浓度，并将数据远传到控制器3；控制器3将各种数据信息传输到上位机5，上位机5生成各个作业区域的浓度时间图(如图2所示)和CT值，供生产技术、管理人员监控消毒状态。同时，控制器3根据设定浓度和检测到的各个作业区域的臭氧浓度的值调节臭氧发生器2产 生臭氧的量，以控制各个作业区域的臭氧浓度，在作业区域的臭氧浓度达到设定值时开始计算消毒时间和CT值。在各个作业区域的CT值均达到设定值时关闭臭氧发生器2，打开新风入口11，清洁作业区微生物控制***退出消毒模式，进入维持模式。
维持模式下，新风入口11打开，洁净空调1在通过回风口12回风的同时通过新风入口11补入经过初效过滤器的新风，在洁净空调1中调温、调湿，并经中效、高效过滤器过滤后，恒温恒湿的清洁空气通过出风口18进入出风管道7，并通过出风管道7进入清洁作业区6，清洁作业区6臭氧浓度快速下降，并维持无菌状态。清洁作业区6的气压呈正压状态，部分空气通过回风管道8进入洁净空调的回风口12进行循环，部分空气从清洁作业区6逸出。清洁作业区6的正气压状态有助于维持清洁作业区6的清洁度。
以下给出本发明的控制清洁作业区微生物的方法的几个实施例，所有实施例中的清洁作业区微生物控制***均采用上述实施方式中所给出的具体实现方式。在消毒结束后、生产启动前，按国家标准标准方法取样检测浮游菌和擦拭设备表面进行设备表面微生物的检测的验证。
实施例1
1)洁净区设备、设施清洁完毕后，关闭清洁空调1的新风入口11，停止新风补充，开启臭氧发生器2，通过清洁空调1的出风管道7将臭氧送入清洁作业区6的空气中，在各个作业区域的臭氧浓度检测仪4的检测值达25ppm时开始计时。
2)在臭氧消毒的CT值达到12000mg/m 3·min时，停止臭氧发生器2工作，打开清洁空调1的新风入口11补充经过清洁空调1处理的清洁空气。
3)通过清洁空调的恒温恒湿功能，将清洁作业区的温度控制在25℃、相对湿度控制在30％。
实施例2
1)洁净区设备、设施清洁完毕后，关闭清洁空调1的新风入口11，停止新风补充，开启臭氧发生器2，通过清洁空调1的出风管道7将臭氧送入清洁作业区6的空气中，在各个作业区域的臭氧浓度检测仪4的检测值达20ppm时开始计时。
2)在臭氧消毒的CT值达到9000mg/m 3·min时，停止臭氧发生器2工作，打开清洁空调1的新风入口11补充经过清洁空调1处理的清洁空气。
3)通过清洁空调的恒温恒湿功能，将清洁作业区的温度控制在24℃、相对湿度控制在15％。
实施例3
1)洁净区设备、设施清洁完毕后，关闭清洁空调1的新风入口11，停止新风补充，开启臭氧发生器2，通过清洁空调1的出风管道7将臭氧送入清洁作业区6的空气中，在各个作业区域的臭氧浓度检测仪4的检测值达30ppm时开始计时。
2)在臭氧消毒的CT值达到14400mg/m 3·min时，停止臭氧发生器2工作，打开清洁空调1的新风入口11补充经过清洁空调1处理的清洁空气。
3)通过清洁空调的恒温恒湿功能，将清洁作业区的温度控制在26℃、相对湿度控制在45％。
实施例4
1)洁净区设备、设施清洁完毕后，关闭清洁空调1的新风入口11，停止新风补充，开启臭氧发生器2，通过清洁空调1的出风管道7将臭氧送入清洁作业区6的空气中，在各个作业区域的臭氧浓度检测仪4的检测值达10ppm时开始计时。
2)在臭氧消毒的CT值达到10000mg/m 3·min时，停止臭氧发生器2工作，打开清洁空调1的新风入口11补充经过清洁空调1处理的清洁空气。
3)通过清洁空调的恒温恒湿功能，将清洁作业区的温度控制在30℃、 相对湿度控制在65％。
对照例
1)洁净区设备、设施清洁完毕后，关闭清洁空调1，在清洁作业区6的每个作业区域放置2-4个装入20ml、200ppm二氧化氯溶液的平皿，熏蒸120分钟。
2)打开清洁空调1，将清洁作业区6的温度设置为25℃，通过新风入口11补充经过清洁空调1处理的清洁空气。
在熏蒸结束后、生产启动前，按国家标准方法检测空气浮游菌和擦拭设备表面进行设备表面微生物检测。
所有实施例和对照例的检测结果见表2和表3。
表2：清洁作业区空气微生物指标检测结果
Figure PCTCN2019086317-appb-000002
表3：设备表面微生物擦拭检测结果：个/25cm 2
Figure PCTCN2019086317-appb-000003
Figure PCTCN2019086317-appb-000004
从表2的检测结果可以看出，相比于对照例，采用本发明的控制清洁作业区微生物的方法的实施例空气中的浮游菌和沉降菌的菌落数更少，且生产5天后空气中微生物数量的增加也更慢。从表3的检测结果可以看出，相比于对照例，采用本发明的控制清洁作业区微生物的方法的实施例设备表面的微生物数量更少，生产5天后设备表面的微生物数量也较少，本发明的控制清洁作业区微生物的方法具有更加明显的消毒和抑制微生物滋生的效果。本发明的控制清洁作业区微生物的方法可应用于食品、保健品或药品生产领域的清洁作业区环境微生物的控制。
以上详细描述了本发明的优选实施方式，但是，本发明并不限于此。在本发明的技术构思范围内，可以对本发明的技术方案进行多种简单变型，包括各个技术特征以任何其它的合适方式进行组合，这些简单变型和组合同样应当视为本发明所公开的内容，均属于本发明的保护范围。

Claims (9)

  1. 一种清洁作业区微生物控制***，其特征在于，包括洁净空调(1)、臭氧发生器(2)、臭氧浓度检测仪(4)和控制器(3)；
    所述洁净空调(1)具有除湿保温和新风补充功能；所述臭氧发生器(2)的输出管连接到所述洁净空调(1)的出风管道(7)；所述臭氧浓度检测仪(4)设置在清洁作业区(6)的作业区域；所述控制器(3)分别与所述洁净空调(1)、臭氧发生器(2)和臭氧浓度检测仪(4)信号连接。
  2. 根据权利要求1所述的清洁作业区微生物控制***，其特征在于，所述臭氧浓度检测仪(4)设置有多个，分布在清洁作业区(6)的不同作业区域。
  3. 根据权利要求1或2所述的清洁作业区微生物控制***，其特征在于，所述臭氧浓度检测仪(4)带有远传装置，并通过远传装置与所述控制器(3)信号连接；所述控制器(3)为PLC。
  4. 根据权利要求1或2所述的清洁作业区微生物控制***，其特征在于，还包括上位机(5)，所述控制器(3)带有上位机接口，与所述上位机(5)信号连接。
  5. 根据权利要求1所述的清洁作业区微生物控制***，其特征在于，所述洁净空调(1)包括新风入口(11)、回风口(12)、风机(13)、中效过滤器(14)、温度调节单元(15)、湿度调节单元(16)、高效过滤器(17)和出风口(18)；新风入口(11)和回风口(12)连通到风机(13)，空气在风机(13)的作用下依次通过中效过滤器(14)、温度调节单元(15)、湿度调节单元(16)和高效过滤器(17)通过出风口(18)排出。
  6. 一种控制清洁作业区微生物的方法，其特征在于，包括以下步骤：
    1)关闭洁净空调(1)的新风补充功能，通过洁净空调(1)的出风管道(7)将臭氧经循环风不间断送入清洁作业区(6)进行消毒，保持清洁作业区(6)臭氧浓度在不低于10ppm，时间不短于0.5小时；
    2)开启洁净空调(1)的新风补充功能，向清洁作业区(6)送入经洁净空调(1)处理的包含新风的清洁空气，并且将清洁作业区(6)的温度维持在≤30℃、相对湿度维持在≤65％。
  7. 根据权利要求6所述的控制清洁作业区微生物的方法，其特征在于，在所述步骤1)中，保持所述清洁作业区(6)的臭氧浓度为30ppm，维持时间1-4小时。
  8. 根据权利要求6所述的控制清洁作业区微生物的方法，其特征在于，在所述步骤1)中，通过臭氧浓度与持续时间的乘积来实时监控、评估实际消毒效果，将臭氧浓度与持续时间的乘积控制在9000-14400mg/m 3min。
  9. 根据权利要求6-8任一项所述的控制清洁作业区微生物的方法，其特征在于，所述清洁作业区(6)为用于食品、保健品或药品生产的清洁作业区。
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