Space decontaminating method

Abstract

The invention relates to the field of decontaminating methods, and discloses a space decontaminating method which comprises the following steps: 1, placing a hydrogen peroxide space sterilizer and bacterial tablets in a B + A region; 2, closing the B + A area and decontaminating the B + A area through a hydrogen peroxide space sterilizer; and 3, taking out and culturing the bacterial slices, and detecting the pollution removal effect by observing the growth condition of the bacterial slices. A hydrogen peroxide space sterilizer is adopted to decontaminate a B + A level area, so that the use of formaldehyde is avoided, and the harm to a human body caused by the existence of the formaldehyde is further avoided. Meanwhile, toxic residues are not generated in the decontaminating process by adopting the hydrogen peroxide sterilizer, the influence on other articles is small, the method is safe to a human body, the decontaminating time is short, and verification is easy.

Description

Technical Field

[0001] The present invention relates to the technical field of decontamination methods, and in particular to a space decontamination method. Background Art

[0002] Decontamination of clean areas in pharmaceutical factories is an important production link for quality assurance of drug production. In order to ensure that product quality is free from microbial contamination during the production process, decontamination must be carried out every day and every batch. Despite this, it is difficult to control microorganisms in the environmental space. The seemingly simple decontamination process, in order to meet the relevant decontamination requirements, it is particularly important to choose the right decontamination method. The commonly used method for space decontamination is formaldehyde fumigation. The bactericidal ability of formaldehyde is unquestionable, but with the development of science and technology, it is increasingly not recognized by certification experts, and formaldehyde is a first-class carcinogen. The powder-liquid double-chamber bag product is a newly developed domestic sterile drug that includes two dosage forms, infusion and powder. Its feature is that non-PVC infusion bags are used to fill liquid infusion and powder drugs separately to form a whole, which is convenient for clinical use and improves drug safety. Its production process covers two major parts: non-PVC soft bag infusion production and powder packaging. Non-PVC soft bag infusion production has a mature production system, including: liquid preparation, bag making and filling, sterilization bag preparation and disinfection, sterilization bag, light inspection, packaging and production assistance, etc. Its process is as follows Figure 1 shown.

[0003] The liquid preparation is set in the C-level clean area, the bag making and filling is set in the C+A-level clean area, the clean area is regularly decontaminated by ozone, the production auxiliary is set in the clean area of ​​the clean level required by the assisted process, and the others are set in the ordinary production area.

[0004] The powder packaging is set up in a sterile environment, in the B+A grade area. Due to the particularity of the double-chamber bag product, its production process is not a simple superposition of the two dosage forms of drug production systems. How to reasonably arrange the entire production system according to the particularity of the double-chamber bag product itself and the process requirements of the two dosage forms, so as to achieve an organic combination of the production processes of the two dosage forms, improve space utilization, and ensure the efficient operation of the entire production system, has become a problem that technicians need to solve. Due to the particularity of the current sterile environment; The use of formaldehyde fumigation can effectively decontaminate the B+A grade area space and ensure that the sterility of sterile drugs in the production process meets the requirements, but the harm of formaldehyde itself to operators in the area is difficult to assess. Summary of the invention

[0005] In view of the problems existing in the prior art, the purpose of the present invention is to provide a space decontamination method to solve the problem that in the production process of powder-liquid double-chamber bags in the prior art, powder packaging is set in the B+A grade area, and the B+A area is decontaminated by formaldehyde fumigation, but formaldehyde itself has the problem of great harm to the human body.

[0006] A space decontamination method comprises the following steps: The first step is to place a hydrogen peroxide space sterilizer and bacterial sheets in the B+A area; In the second step, the B+A area is sealed and decontaminated by a hydrogen peroxide space sterilizer; The third step is to take out and culture the bacterial slices, and detect the decontamination effect by observing the growth of the bacterial slices.

[0007] Furthermore, in the first step, the number and placement of the hydrogen peroxide space sterilizers need to be set according to the number of rooms in the B+A area, the area of ​​each room, and the placement and density of the equipment in each room.

[0008] Furthermore, in the first step, the bacterial sheet is arranged at a corner of each room, and the breathing surface of the bacterial sheet is arranged on the side away from the wall.

[0009] Furthermore, in the second step, when closing the B+A area, it is necessary to ensure the connectivity of the rooms to be decontaminated, and to close the rooms that do not need to be decontaminated.

[0010] Furthermore, in the second step, the hydrogen peroxide space sterilizer is equipped with a remote controller; the hydrogen peroxide space sterilizer can be started for decontamination by a countdown start mode or a scheduled time start mode or by a remote controller remote start mode.

[0011] Furthermore, in the second step, the spraying amount and the volume of the decontaminated area can be set in the hydrogen peroxide space sterilizer.

[0012] Furthermore, in the third step, before taking out the bacterial slices, the B+A area needs to be ventilated and residual exhaust verification is performed until the residual hydrogen peroxide concentration is reduced to less than or equal to 1 ppm.

[0013] Furthermore, in the third step, when culturing the bacterial slice, the bacterial slice needs to be inoculated first, and then transferred to a constant temperature incubator after inoculation; the constant temperature incubator is provided with a soytone liquid culture medium, the culture temperature is 55°C-60°C, and the culture time is greater than or equal to 15 days.

[0014] Beneficial effects: Compared with the formaldehyde fumigation decontamination method used in the prior art; the use of a hydrogen peroxide space sterilizer to decontaminate the B+A grade area avoids the use of formaldehyde, thereby avoiding the harm to the human body caused by the presence of formaldehyde; the hydrogen peroxide space sterilizer utilizes the characteristics of submicron hydrogen peroxide dry mist with super strong spore killing ability at room temperature, and generates free HO-, which is used to attack cell components, including lipids, proteins and DNA tissues, and can be quickly converted into H2O / O2 / CO2 to achieve the purpose of complete decontamination. No toxic residues are generated during the decontamination process, and it has little effect on other items. It is safe for the human body, takes a short time to decontaminate, and is easy to verify. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the specification will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0016] Figure 1 It is a prior art process flow chart of the present invention; Figure 2 Schematic diagrams of various structures of space decontamination equipment according to embodiments of the present invention. DETAILED DESCRIPTION

[0017] The technical solutions in the embodiments of the present invention are described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. For ease of explanation, the terms "vertical", "horizontal", "left", "right", "upper", "lower", "inner", "outer", "bottom", etc. used in this specification indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0018] It should be noted that the embodiments of the present invention and the features involved in the embodiments can be combined with each other without conflict. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0019] A space decontamination method comprises the following steps: a first step, setting a space decontamination device and a bacterial sheet in a B+A class clean space; a second step, sealing the B+A class area and decontaminating it through the space decontamination device; a third step, taking out and culturing the bacterial sheet, and detecting the decontamination effect by culturing the bacterial sheet.

[0020] The space decontamination equipment uses a hydrogen peroxide space sterilizer.

[0021] In this embodiment, compared with the formaldehyde fumigation decontamination method used in the prior art, a hydrogen peroxide space sterilizer is used to decontaminate the B+A grade area, thereby avoiding the use of formaldehyde and further avoiding the harm to the human body caused by the presence of formaldehyde. The hydrogen peroxide space sterilizer utilizes the characteristics of submicron hydrogen peroxide dry mist having super strong spore killing ability at room temperature, and generates free HO-, which is used to attack cell components, including lipids, proteins and DNA tissues, and can be quickly converted into H2O / O2 / CO2 to achieve the purpose of complete decontamination. No toxic residues are generated during the decontamination process, and it has little effect on other items. It is safe for the human body, takes a short time to decontaminate, and is easy to verify.

[0022] When setting up the space decontamination equipment in the first step, the number and placement of the space decontamination equipment in the corresponding room are adjusted according to the number of rooms in the B+A area, the area of ​​each room, the placement of the equipment in the room and the density of the equipment; then the amount of disinfectant required for each device is calculated according to the number of space decontamination equipment set up in each room; how to set the number and position of the space decontamination equipment and calculate the amount of disinfectant is a prior art and will not be elaborated on here.

[0023] When installing the mushroom slices in the first step, hang them in the corner of the room, with the breathing surface of the slices on the side facing away from the wall. At the same time, avoid the slices from sticking to the wall.

[0024] In this embodiment, by setting and adjusting the number and placement of space decontamination equipment, the concentration of sterilizing dry mist in each room can be uniformly and quickly increased, and the sterilizing dry mist can be quickly diffused to every corner of the room, effectively accelerating the decontamination speed, improving the decontamination effect, and avoiding virus residues in the corners. The location of the bacterial sheet is set at the farthest end of the decontamination space, which is representative. Through subsequent cultivation and observation of the bacterial sheet, the decontamination effect can be easily observed.

[0025] In the second step, the B+A area is sealed, including shutting down air conditioners, exhaust fans and other equipment that exchange gases with the outside world, ensuring the connectivity of the rooms to be decontaminated, closing the rooms that do not need to be decontaminated, and sealing the gaps of the doors at the entrances and exits of the staff. After closing other areas connected to the B+A area, a review is required to check whether they are properly closed.

[0026] In this embodiment, the B+A area is sealed to prevent the entry of external microorganisms and viruses and the outflow of sterilization dry mist in the room, thereby avoiding the residual microorganisms and viruses generated by the exchange of gases in the room with the outside world.

[0027] In the second step, after decontamination by the space decontamination equipment, the B+A area needs to be exhausted to remove the residual sterilization dry mist; after exhausting, the concentration of hydrogen peroxide is tested through residual exhaust verification until the concentration of hydrogen peroxide is reduced to below 1ppm. When the concentration of hydrogen peroxide is reduced to below 1ppm, stop exhausting and residual exhaust inspection.

[0028] In this embodiment, the exhaust setting is used to avoid the impact of excessively high concentrations of hydrogen peroxide on the human body; the concentration of hydrogen peroxide is reduced to below 1 ppm, which can minimize the impact on the human body.

[0029] In the third step, the bacterial slices need to be inoculated when they are cultured. After the inoculation is completed, they are transferred to a constant temperature incubator, in which a tryptic soy peptone liquid culture medium is set. The culture temperature is set at 55-60°C, and the culture time is greater than or equal to 15 days.

[0030] In this embodiment, the growth of the bacterial slices in the incubator is observed after 15 days to confirm whether any abnormalities occur. If no abnormalities occur, the decontamination effect reaches the ideal value. If any abnormalities occur, the cause is investigated and the next decontamination process is adjusted accordingly.

[0031] The hydrogen peroxide space sterilizer is an existing technology, including a stainless steel shell, a handle, a nozzle, a fan, an operating screen, a USB interface, a power socket, an antenna, a status indicator light, a liquid storage bottle, an indicator light, etc.; the hydrogen peroxide space sterilizer is equipped with a remote control, and the spray amount, the volume of the decontaminated area and other related parameters can be set through the operating screen, and the hydrogen peroxide space sterilizer can be remotely controlled by the remote control to spray hydrogen peroxide dry mist or stop spraying hydrogen peroxide dry mist.

[0032] Working principle: personnel enter the decontamination area, calculate the required amount of medicine and the number of decontamination equipment and equipment placement according to the area of ​​the decontamination area, place the hydrogen peroxide decontamination equipment at the designated location, and hang the bacterial sheet in the corner of the room (the bacterial sheet should be suspended in the air and not close to the wall. The breathing side should face outward); connect the hydrogen peroxide decontamination equipment to the power supply, and place disinfectant in the hydrogen peroxide decontamination equipment; As shown in the decontamination of the B+A grade area in this plant, in the sterilizer, equipment No. 1 is set with 800g disinfectant, equipment No. 2 is set with 800g disinfectant, equipment No. 3 is set with 670g disinfectant, equipment No. 4 is set with 800g disinfectant, equipment No. 5 is set with 900g disinfectant, equipment No. 6 is set with 4000g disinfectant, equipment No. 7 is set with 4400g disinfectant, equipment No. 8 is set with 4000g disinfectant, equipment No. 9 is set with 4000g disinfectant, and equipment No. 10 is set with 4000g disinfectant; Turn off the air conditioner and exhaust equipment; open the doors and windows of all rooms in the clean area that need dry fog decontamination to facilitate the spread of dry fog to every corner, and close the doors and windows of rooms that do not need dry fog decontamination (key link, need to ensure complete stillness, need to be reviewed).

[0033] After the sterilizer is initialized, click the OK button on the prompt interface, and the login interface will appear. Click the blank box, and the data input keyboard will pop up. Enter the correct user name and password. After entering, click Login to enter the main interface. After entering the main interface, various function modules will be displayed. You can switch the main interface pages by clicking the left and right arrows on the screen; click the corresponding function module frame on the main interface to enter the corresponding interface. Personnel with corresponding authority can enter the authorized interface. Click the decontamination formula frame on the main interface to enter the formula interface. You can create a formula template. Click the blank text box to pop up the edit formula dialog box. Click the corresponding blank text box, enter the corresponding parameters and confirm that they are correct. Click OK to complete the decontamination formula establishment. This template can be directly called for subsequent decontamination operations.

[0034] If you need to create another decontamination formula template, click the corresponding blank text box and repeat the above steps. You can create up to 120 decontamination formula templates. Formula name: modify the name defined by this decontamination formula template. Spray volume: modify the spray volume required for this decontamination formula template. Space size: modify the volume of the decontamination area of ​​this equipment. The spray volume and the volume of the decontamination area are both parameter settings.

[0035] After the initial template is established, if you need to modify the created decontamination formula template, click the corresponding decontamination formula text box to pop up the edit formula submenu. Through the menu, you can choose to use the initial template parameters, edit and modify the template parameters, and delete the template; if you need to exit, click Cancel to exit the template editing, click to select the decontamination formula template you need to use, and this box will pop up. After clicking the button, the page will jump directly to the decontamination operation interface. Click the button to exit this pop-up box, click the main interface decontamination operation frame, and enter this decontamination operation interface. When the decontamination operation starts, you need to check whether the template used on the screen is correct. Set the parameters correctly and whether the operation status is normal; before starting the decontamination, please select and edit the decontamination start mode, using countdown operation, scheduled timing operation, and remote control start operation. After confirming the settings are correct, click the decontamination start button, and a pop-up box for entering the batch number will pop up. Click the blank document in the pop-up box and enter the batch number for this decontamination. After completion, click Confirm to start the decontamination work. If other decontamination templates are needed for decontamination, please switch to the decontamination formula interface and select the decontamination template to be used. After selecting Confirm, it will automatically jump to this interface.

[0036] Countdown start instructions: click the blank box of the operation mode, a submenu will pop up, select countdown, a dialog box will pop up, enter the countdown time and click confirm, after confirmation, jump to the operation interface, click the start button, a dialog box will pop up, enter the decontamination batch number, click confirm, the equipment starts timing, after the timing is completed, the equipment starts to run automatically, click the start button again to cancel this operation, appointment timed start instructions: click the blank box of the operation mode, select timing, a dialog box will pop up, enter the equipment start time and click confirm, after confirmation, jump to the operation interface, click the start button, a dialog box will pop up, enter the decontamination batch number, click confirm, the equipment starts timing, the equipment starts to run automatically after reaching the set time point, click the start button again to cancel this operation; Remote control start instructions: Click the blank box of the operation mode, select remote control, click the start button, a dialog box will pop up to enter the decontamination batch number, click confirm, press the remote control start button, the equipment will start running immediately, press the remote control shutdown button, the equipment will stop running immediately, according to the decontamination start time requirements, choose to run immediately or schedule to run, click the start button, the equipment interface will pop up a prompt to enter the batch number, choose to enter or not enter the batch number according to the company's needs, click YES, the equipment will start spraying according to the set time, The personnel leave the decontamination area, close the door of the decontamination area, and seal the gap between the door and the ground with traceless tape. After all preparations are completed, start the space decontamination equipment; Specific working principle: In the preparation stage, place the hydrogen peroxide space sterilizer loaded with sporicide, adjust the injection port orientation, connect the power supply of the hydrogen peroxide space sterilizer and turn on the power supply, set the decontamination parameters, seal the decontaminated space, evacuate the decontaminated space environment and seal the personnel exit; select the operation mode, and the equipment automatically starts spray decontamination after the delay ends. In the spray vaporization stage, the hydrogen peroxide space sterilizer sprays sporicide to the decontaminated area to complete the spray vaporization process. In the decontamination stage, after the spray vaporization process is completed, let it stand for a period of time to allow the diffused sporicide vapor to fully decontaminate the space and surface. Record the time and calculate the working time according to the spray time of the equipment with the largest spray volume in the workshop, which is about 145 minutes. After 3 hours, the workshop was fully ventilated for 40 minutes to verify the residual exhaust. After the residual exhaust and ventilation time, the residual concentration of hydrogen peroxide in the room could be reduced to 1ppm. The personnel changed their clothes according to the sterile dressing requirements and entered the sterile room to take out the previously posted bacterial slices. The bacterial slices were taken to the biosafety cabinet or ultra-clean workbench for inoculation. After inoculation, they were transferred to the constant temperature incubator for cultivation. The culture medium was tryptic soy bean liquid culture medium, and the culture temperature was 55-60℃. After 15 days of cultivation, no abnormal growth of bacteria occurred on the bacterial slices.

[0037] Although preferred embodiments of the present invention have been described, additional changes and modifications may be made to these embodiments by those skilled in the art once the basic inventive concepts are known. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention. Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A space decontamination method, characterized in that: The steps include: The first step is to place a hydrogen peroxide space sterilizer and bacterial sheets in the B+A area; In the second step, the B+A area is sealed and decontaminated by a hydrogen peroxide space sterilizer; The third step is to take out and culture the bacterial slices, and detect the decontamination effect by observing the growth of the bacterial slices.

2. A space decontamination method according to claim 1, characterized in that: In the first step, the number and placement of the hydrogen peroxide space sterilizers need to be set according to the number of rooms in the B+A area, the area of ​​each room, and the placement and density of the equipment in each room.

3. A space decontamination method according to claim 2, characterized in that: In the first step, the bacterial sheet is arranged at the corner of each room, and the breathing surface of the bacterial sheet is arranged on the side away from the wall.

4. A space decontamination method according to claim 2, characterized in that: In the second step, when closing the B+A area, ensure the connectivity of the rooms to be decontaminated and close the rooms that do not need to be decontaminated.

5. A space decontamination method according to claim 2, characterized in that: In the second step, the hydrogen peroxide space sterilizer is equipped with a remote control; the hydrogen peroxide space sterilizer can be started for decontamination by a countdown start method or a scheduled time start method, or the hydrogen peroxide space sterilizer can be started for decontamination by a remote control remote start method.

6. A space decontamination method according to claim 2, characterized in that: In the second step, the spraying amount and the volume of the decontaminated area can be set in the hydrogen peroxide space sterilizer.

7. A space decontamination method according to claim 1, characterized in that: In the third step, before taking out the bacterial slices, the B+A area needs to be ventilated and the residual exhaust verification is performed until the residual hydrogen peroxide concentration is reduced to less than or equal to 1ppm.

8. A space decontamination method according to claim 1, characterized in that: In the third step, when culturing the bacterial slice, the bacterial slice needs to be inoculated first, and then transferred to a constant temperature incubator after inoculation; the constant temperature incubator is provided with a soytone liquid culture medium, the culture temperature is 55°C-60°C, and the culture time is greater than or equal to 15 days.

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