WO2023129111A2 - Sterilization control device that can perform fast detection for sterilization control - Google Patents

Sterilization control device that can perform fast detection for sterilization control Download PDF

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Publication number
WO2023129111A2
WO2023129111A2 PCT/TR2022/051734 TR2022051734W WO2023129111A2 WO 2023129111 A2 WO2023129111 A2 WO 2023129111A2 TR 2022051734 W TR2022051734 W TR 2022051734W WO 2023129111 A2 WO2023129111 A2 WO 2023129111A2
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WO
WIPO (PCT)
Prior art keywords
control device
sterilization control
sterilization
bioindicators
compartments
Prior art date
Application number
PCT/TR2022/051734
Other languages
French (fr)
Other versions
WO2023129111A3 (en
Inventor
Murat Ali YÜLEK
Burak ÜNAL
Ahmet KOLUMAN
Muhammet UĞAN
Mahmed Sari NJJAR
Bahattin Gökhan TOPAL
Original Assignee
Osti̇m Tekni̇k Üni̇versi̇tesi̇
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Osti̇m Tekni̇k Üni̇versi̇tesi̇ filed Critical Osti̇m Tekni̇k Üni̇versi̇tesi̇
Publication of WO2023129111A2 publication Critical patent/WO2023129111A2/en
Publication of WO2023129111A3 publication Critical patent/WO2023129111A3/en

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Classifications

    • 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
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/22—Testing for sterility conditions

Definitions

  • the invention relates to a sterilization control device that simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.
  • Bioindicators are test systems that contain live microorganisms which are used in a specific sterilization process and that have endurance. Bioindicators provide a level of confidence in whether certain conditions are met in a sterilization process. For this purpose, live microorganisms in bioindicators are commonly used.
  • This type of test system can be used in central sterilization units/microbiology laboratories in healthcare services and for the control of sterilization processes in the food industry.
  • Bioindicators are test materials containing microorganisms or their spores and an indicator (for example, a pH indicator). As a result of the sterilization process using a bioindicator, the color change is monitored on the indicator in order to determine the effectiveness of the process. Color changes inform the user about the effectiveness of sterilization. This visual process takes place through self-observation. At this point, a long period of time (about 12 hours) is required for a definitive result, as the person is likely to miss subtle color changes. In this process, the indicator continues to change color. Since sensitive examinations cannot be performed by eye, there is a great loss of time during sterilization control. Especially the loss of time in the industrial field causes disruption of production processes and indirectly, commercial loss. This loss of time in the field of health services and microbiology laboratories also disrupts public services. In terms of public health, it is a great risk to reach a conclusion by making a visual examination.
  • an indicator for example, a pH indicator
  • bioindicator readers In order to eliminate these technical problems, bioindicator readers have been developed. In order to increase the reliability of the tests, similar bioindicator readers belonging to the state of the art make specific readings only on a single microorganism. This does not enable simultaneous control of bioindicators with different microorganisms at the end of sterilization.
  • the apparatus comprises one or more means for the automatic loading, transfer, and emptying of a sample container.
  • the apparatus further comprises a detection system for receiving a detection vessel containing a biological sample and culture medium.
  • the detection system also comprises heat sources, holding structures or shelves, and a sensing unit for detecting whether the container is positive for the presence of a microbial substance. It is evident from the description that the sensing unit may be an optical system.
  • the system of the patent application numbered US3925166A is a system that automatically determines the susceptibility of more than one different antibiotic to a certain bacterial species.
  • the system comprises an advanced sample plate with multiple channels for different concentrations and different antibiotics.
  • the plate is scanned with an intense beam of light both before and after incubation to count the number of bacterial colonies in each channel to determine which antibiotic best fights the particular bacterial strain.
  • the output of these scans is analyzed on a computer.
  • the invention intends to provide a sterilization control device that simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.
  • the device of the invention simultaneous incubation of bioindicators containing different microorganisms during the sterilization control stage is carried out in the device and simultaneous optical readings are performed. In this way, the control is followed in more than one step.
  • the devices used in the market perform single-stage follow-ups with a single microorganism, or in multi-stage follow-ups, people can perform examinations by eye for a long time. Since both practices involve risks, public health is jeopardized.
  • the device of the invention which can perform multiple simultaneous readings, provides advantages in terms of time and increases reliability.
  • the gain in terms of time indirectly affects costs, while increased reliability has a positive impact on public health.
  • FIG. 1 Perspective view of the sterilization control device with the cover open.
  • FIG. 1 Perspective view of the sterilization device with the control unit demounted.
  • FIG. 1 Front view of the sterilization control device with the cover open.
  • the invention relates to a sterilization control device that can simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.
  • the said device comprises the following in its structure
  • control unit (4) which can control both the said heat sensors and heat transfer elements as well as the optical sensors
  • a display unit (5) that provides the display of data generated by the control unit (4).
  • the device of the invention can be examined in 3 separate sections. These can be summarized as the control unit (4), the compartments (3) where the bioindicators are located, and the display unit (5).
  • control unit (4) is in the form of an electronic card.
  • it can comprise electronic communication equipment in its structure.
  • Figure 2 shows the said electronic card separated from the body (1).
  • the electronic card is fixed horizontally inside the device and on the back cover.
  • the control unit (4) also provides control of the display unit (5).
  • the display unit (5) can be in the form of a screen as shown in Figure 1.
  • heat sensors are in the form of sensors.
  • the electronic card provides the operation of the sensors in the device; receiving and processing of the data from the sensors, and transfer of the processed meaningful data.
  • the power input and communication ports of the electronic card are on the device, and the power button, which is used to turn the device on and off, is on the device and is connected to the electronic card.
  • each compartment (3) is designed for the simultaneous processing of two bioindicators.
  • each compartment (3) consists of two separate areas (3.1). It is possible to incubate the bioindicator tubes to be placed in these areas (3.1) at two different temperatures. For example, two areas (3.1) will enable the application of incubation temperatures at two different temperatures of 50 and 37 °C.
  • Figure 1 shows the compartments (3) in which the incubation media can be placed in the form of a cuvette.
  • These areas (3.1) are also equipped with temperature sensors and with the help of these sensors, the temperature of the incubation cuvette is monitored.
  • the data received from the temperature sensor is sent to the electronic card.
  • Incoming data about the temperature of the cuvette is interpreted on the electronic card and the heating circuit in the compartments is controlled according to the decision status.
  • the heat transfer elements are in the form of a heater circuit.
  • USB there is one USB and one RS232 connection socket on the device.
  • connection sockets data transfer is carried out by serial communication between the device and the computer.
  • a display unit (5) in the form of a screen was created on the body (1) of the device.
  • the display unit (5) is more specifically in the form of a Led screen in this embodiment. With this screen, the remaining time to complete the incubation can be displayed.
  • test results can be obtained via a printer, or the test data can be transferred by connecting to a computer.
  • the device can also contain different display units (5) within its structure. For example, different notifications such as whether the device cover is closed, the incubation process, and whether the device is switched on can alert the user in the same display unit (5) or separate display units (5).
  • the body (1) of the device can be equipped with different LEDs for this purpose.
  • the cover (2) of the device after the cover (2) of the device is opened, its back is also equipped with a glass cover.
  • the glass cover will allow the compartments (3) to be kept closed even if the cover (2) is opened.
  • bioindicators of the invention consisting of vegetative and spore microorganisms in sterilization controls by a color change on the bioindicator, it can be used in health, food, etc. sectors. Since it comprises at least 2 compartments (3) and/or areas (3.1) with different incubation conditions within its structure, the effectiveness of at least 2 different microorganisms subjected to the same sterilization process can be reliably measured.
  • the preferred embodiment of the invention comprises cuvettes where bioindicators can be placed simultaneously and microorganism- specific incubation can be achieved. During the incubation period, optical readings are performed on bioindicators in these cuvettes. During this process, the color changes on the bioindicators are read by optical method, and the result obtained is evaluated in line with the changing color spectrum of the bioindicator.

Abstract

The invention relates to a sterilization control device that simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.

Description

STERILIZATION CONTROL DEVICE THAT CAN PERFORM FAST DETECTION FOR STERILIZATION CONTROL
Technical Field
The invention relates to a sterilization control device that simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.
State of the Art
Regardless of the method of sterilization, it should be ensured that each step of the process is performed accurately in sterilization control. Evidence showing that each step has been tested is required. As proof of an effective sterilization process; physical control, chemical control, and biological controls need to be performed and documented.
Due to reasons such as sterilization control, malfunction, breakdown of the systems that provide sterilization, incomplete sterilization, etc., it is important to detect whether sterilization is realized in the desired effectiveness.
Bioindicators are test systems that contain live microorganisms which are used in a specific sterilization process and that have endurance. Bioindicators provide a level of confidence in whether certain conditions are met in a sterilization process. For this purpose, live microorganisms in bioindicators are commonly used.
This type of test system can be used in central sterilization units/microbiology laboratories in healthcare services and for the control of sterilization processes in the food industry.
Bioindicators are test materials containing microorganisms or their spores and an indicator (for example, a pH indicator). As a result of the sterilization process using a bioindicator, the color change is monitored on the indicator in order to determine the effectiveness of the process. Color changes inform the user about the effectiveness of sterilization. This visual process takes place through self-observation. At this point, a long period of time (about 12 hours) is required for a definitive result, as the person is likely to miss subtle color changes. In this process, the indicator continues to change color. Since sensitive examinations cannot be performed by eye, there is a great loss of time during sterilization control. Especially the loss of time in the industrial field causes disruption of production processes and indirectly, commercial loss. This loss of time in the field of health services and microbiology laboratories also disrupts public services. In terms of public health, it is a great risk to reach a conclusion by making a visual examination.
Determining the results based on the opinions of the people at the evaluation point in controlling the effectiveness of sterilization increases the risk of errors that may occur in these results. Hence, the reliability of the tests decreases.
In order to eliminate these technical problems, bioindicator readers have been developed. In order to increase the reliability of the tests, similar bioindicator readers belonging to the state of the art make specific readings only on a single microorganism. This does not enable simultaneous control of bioindicators with different microorganisms at the end of sterilization.
However, the necessity of operating each test process separately by the person using the present systems that can make specific readings on a single microorganism may cause time loss.
It is clear that the patent application numbered WO2010132741A3 describes a method and automated apparatus for the rapid non- invasive detection of a microbial agent in a test sample. The apparatus comprises one or more means for the automatic loading, transfer, and emptying of a sample container. The apparatus further comprises a detection system for receiving a detection vessel containing a biological sample and culture medium. The detection system also comprises heat sources, holding structures or shelves, and a sensing unit for detecting whether the container is positive for the presence of a microbial substance. It is evident from the description that the sensing unit may be an optical system.
The system of the patent application numbered US3925166A is a system that automatically determines the susceptibility of more than one different antibiotic to a certain bacterial species. The system comprises an advanced sample plate with multiple channels for different concentrations and different antibiotics. The plate is scanned with an intense beam of light both before and after incubation to count the number of bacterial colonies in each channel to determine which antibiotic best fights the particular bacterial strain. The output of these scans is analyzed on a computer.
Problems to be Solved by the Invention
The invention intends to provide a sterilization control device that simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.
In the device of the invention, simultaneous incubation of bioindicators containing different microorganisms during the sterilization control stage is carried out in the device and simultaneous optical readings are performed. In this way, the control is followed in more than one step. In precedent embodiments, the devices used in the market perform single-stage follow-ups with a single microorganism, or in multi-stage follow-ups, people can perform examinations by eye for a long time. Since both practices involve risks, public health is jeopardized.
The device of the invention, which can perform multiple simultaneous readings, provides advantages in terms of time and increases reliability. The gain in terms of time indirectly affects costs, while increased reliability has a positive impact on public health.
Description of the Figures
Figure 1. Perspective view of the sterilization control device with the cover open.
Figure 2. Perspective view of the sterilization device with the control unit demounted.
Figure 3. Front view of the sterilization control device with the cover open.
Description of the References in the Figures
1. Body
2. Cover 3. Compartment
3.1. Area
4. Control unit
5. Display unit icrintion of the Invention
The invention relates to a sterilization control device that can simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings.
The said device comprises the following in its structure;
• a body (1) with at least 2 compartments (3) and/or areas (3.1) where different incubation conditions can be created,
• heat sensors and heat transfer elements that allow the temperature of the bioindicators kept in the said compartment (3) and/or areas (3.1) to be measured and continuously regulated throughout the incubation period, according to the predetermined incubation conditions for each compartment (3) and/or area (3.1);
• optical sensors that allow color data to be obtained from the bioindicators kept in the compartment (3) and/or areas (3.1) during the incubation period,
• a control unit (4), which can control both the said heat sensors and heat transfer elements as well as the optical sensors,
• a display unit (5) that provides the display of data generated by the control unit (4).
The device of the invention can be examined in 3 separate sections. These can be summarized as the control unit (4), the compartments (3) where the bioindicators are located, and the display unit (5).
In the preferred embodiment of the invention, the control unit (4) is in the form of an electronic card. In order to provide all the controls of the electronic card device, communication ports, etc., it can comprise electronic communication equipment in its structure.
Figure 2 shows the said electronic card separated from the body (1). According to this embodiment, the electronic card is fixed horizontally inside the device and on the back cover.
The control unit (4) also provides control of the display unit (5). The display unit (5) can be in the form of a screen as shown in Figure 1.
According to the preferred embodiment of the invention, heat sensors are in the form of sensors. In this case; the electronic card provides the operation of the sensors in the device; receiving and processing of the data from the sensors, and transfer of the processed meaningful data.
The power input and communication ports of the electronic card are on the device, and the power button, which is used to turn the device on and off, is on the device and is connected to the electronic card.
According to the embodiment shown in Figures 1 and 3, there are 2 bio indicator compartments (3) in total in the device. Each compartment (3) is designed for the simultaneous processing of two bioindicators. In this embodiment, each compartment (3) consists of two separate areas (3.1). It is possible to incubate the bioindicator tubes to be placed in these areas (3.1) at two different temperatures. For example, two areas (3.1) will enable the application of incubation temperatures at two different temperatures of 50 and 37 °C.
Figure 1 shows the compartments (3) in which the incubation media can be placed in the form of a cuvette.
These areas (3.1) are also equipped with temperature sensors and with the help of these sensors, the temperature of the incubation cuvette is monitored. The data received from the temperature sensor is sent to the electronic card. Incoming data about the temperature of the cuvette is interpreted on the electronic card and the heating circuit in the compartments is controlled according to the decision status. In this embodiment, the heat transfer elements are in the form of a heater circuit.
These processes continue throughout the incubation period. While this process continues, color data is received via the optical sensors in each compartment (3) and the bioindicator tubes. This data is sent to the electronic card and compared numerically with the color spectrum of the bioindicator. This process provides information about the sterilization control of the bioindicator during the incubation process. As a result of the comparison, the decision status can also be sent to the device to be connected via the communication ports on the electronic card.
According to a preferred embodiment of the invention, there is one USB and one RS232 connection socket on the device. With these connection sockets, data transfer is carried out by serial communication between the device and the computer.
In the embodiment shown in Figure 1, a display unit (5) in the form of a screen was created on the body (1) of the device. The display unit (5) is more specifically in the form of a Led screen in this embodiment. With this screen, the remaining time to complete the incubation can be displayed.
By using the ports on the device, the test results can be obtained via a printer, or the test data can be transferred by connecting to a computer.
The device can also contain different display units (5) within its structure. For example, different notifications such as whether the device cover is closed, the incubation process, and whether the device is switched on can alert the user in the same display unit (5) or separate display units (5). For example, the body (1) of the device can be equipped with different LEDs for this purpose.
According to one of the preferred embodiments of the invention, after the cover (2) of the device is opened, its back is also equipped with a glass cover. The glass cover will allow the compartments (3) to be kept closed even if the cover (2) is opened.
Thereby, even if the cover (2) is opened, the incubation temperature inside the compartments (3) will be maintained.
Since it aims to determine the sterilization efficiency of bioindicators of the invention consisting of vegetative and spore microorganisms in sterilization controls by a color change on the bioindicator, it can be used in health, food, etc. sectors. Since it comprises at least 2 compartments (3) and/or areas (3.1) with different incubation conditions within its structure, the effectiveness of at least 2 different microorganisms subjected to the same sterilization process can be reliably measured.
The preferred embodiment of the invention comprises cuvettes where bioindicators can be placed simultaneously and microorganism- specific incubation can be achieved. During the incubation period, optical readings are performed on bioindicators in these cuvettes. During this process, the color changes on the bioindicators are read by optical method, and the result obtained is evaluated in line with the changing color spectrum of the bioindicator.
Since this whole process can be applied simultaneously to at least two bioindicators that have undergone the same sterilization process in the system, a significant advantage can be achieved.

Claims

CLAIMS A sterilization control device that simultaneously incubate bioindicators containing microorganisms or spores that can react differently under different environmental conditions within the same system and perform simultaneous optical readings, characterized in that it comprises;
• a body (1) with at least 2 compartments (3) and/or areas (3.1) where different incubation conditions can be established,
• heat sensors and heat transfer elements that allow the temperature of the bioindicators kept in the said compartment (3) and/or areas (3.1) to be measured and continuously regulated throughout the incubation period, according to the predetermined incubation conditions for each compartment (3) and/or area (3.1);
• optical sensors that allow color data to be obtained from the bioindicators kept in the compartment (3) and/or areas (3.1) during the incubation period,
• a control unit (4), which can control both the said heat sensors and heat transfer elements as well as the optical sensors,
• a display unit (5) that provides the display of data generated by the control unit (4). A sterilization control device according to Claim 1, characterized in that it comprises a control unit (4) in the form of an electronic card. A sterilization control device according to Claim 1, characterized in that it comprises a display unit (5) which can be in screen form. A sterilization control device according to Claim 3, characterized in that it comprises a display unit (5) which can be in the form of a led screen. A sterilization control device according to Claim 1, characterized in that it comprises heat sensors that can be in the form of sensors and heat transfer elements in the form of heater circuits. A sterilization control device according to Claim 1, characterized in that it comprises compartments (3) formed from two separate areas (3.1) so that two bioindicators can
8 be incubated simultaneously at two different temperatures.
7. A sterilization control device according to Claims 1 and 6, characterized in that it comprises 2 compartments (3) in total.
8. A sterilization control device according to any one of the above claims, characterized in that it comprises compartments (3) where incubation media can be positioned in the form of a cuvette. 9. A sterilization control device according to Claim 1, characterized in that it comprises
USB and RS232 ports.
10. A sterilization control device according to Claim 1, characterized in that it comprises a glass cover allowing the compartments (3) to be kept closed under the cover (2).
9
PCT/TR2022/051734 2021-12-31 2022-12-30 Sterilization control device that can perform fast detection for sterilization control WO2023129111A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2021/022268A TR2021022268A2 (en) 2021-12-31 2021-12-31 STERILIZATION CONTROL DEVICE THAT CAN FAST DETECTION REGARDING STERILIZATION CONTROL
TR2021/022268 2021-12-31

Publications (2)

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WO2023129111A2 true WO2023129111A2 (en) 2023-07-06
WO2023129111A3 WO2023129111A3 (en) 2023-08-31

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WO (1) WO2023129111A2 (en)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060263258A1 (en) * 2005-02-10 2006-11-23 Matthew Harris Automated biological indicator incubator
US9303283B2 (en) * 2013-11-26 2016-04-05 American Sterilizer Company Combined sterilization indicator incubator and reader system
WO2020183434A1 (en) * 2019-03-14 2020-09-17 3M Innovative Properties Company Electronic device with display

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WO2023129111A3 (en) 2023-08-31
TR2021022268A2 (en) 2022-01-21

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