RU98452U1 - BIOLOGICAL SAFETY MODULE - Google Patents

Abstract

 1. The biosafety module for working with microorganisms, containing a hermetically sealed functional box and an adjoining gateway with a sealed entrance door, communicating with each other via a sealed door and equipped with life support equipment, including energy supply, water supply, sewage, heating, air conditioning, and forced-air supply systems and exhaust ventilation, equipped with fine filters, and a communication system, functionally and structurally interconnected, with This functional box is equipped with a biosafety glove box, connected via an air duct and fine filters of the removed air to a separate exhaust ventilation unit, diagnostic equipment and preparations for microbiological and chemical analyzes and toxicological studies, and a transfer window made in the form of a closed sealed chamber with sealed doors installed on the outer and inner sides relative to the functional box, characterized in that the biosafety glove box corresponds to category BSC-III, the walls and ceilings of the functional box and airlock are made in the form of two-layer steel panels with heat and sound insulating material installed between the layers, while the tightness of the functional box and airlock is ensured by each of the layers of wall and ceiling panels, the joints between the walls and the ceiling are sealed around the perimeter, the floor of the functional box and airlock is made bulk from a wear-resistant antistatic polymer mat

Description

The utility model belongs to the class of biological laboratories and can be used to conduct laboratory studies of dangerous and especially dangerous microorganisms that cause infectious diseases. The proposed technical solution is characterized by a high degree of protection of personnel and the environment from possible infection during work with highly pathogenic microorganisms.

The known diagnostic module of the mobile medical diagnostic complex (Military Medical Journal - 1999. - No. 4. - p. 14-21) mounted on the chassis of a cross-country vehicle MAZ-4210 with the diagnostic and auxiliary equipment located in it, as well as electrical equipment, air conditioning and trip computer. In the rear of the body are equipped with built-in cabinets for storing and transporting diagnostic tools, consumables and clothes, and in the front of the body at the level of the side doors there is a vestibule for switching to other modules. The module is designed for laboratory research, as well as storage and transportation of the necessary diagnostic equipment. This module is selected as an analog. The main disadvantage of the known analogue is the impossibility of express indication of pathogens of especially dangerous and unknown infectious diseases, taking into account the biological safety requirements for this type of work.

Another analogue of the claimed utility model is known, for example, a mobile chemical-analytical laboratory mounted in a car van, equipped with a heating, air conditioning system, a water treatment system for laboratory needs, an exhaust box with a fan for working with aggressive reagents and media, with a control placed on laboratory tables -measurement equipment for measuring various parameters associated with the on-board computer and having a printer (RF patent No. 2251496, IPC B60P 3/14, publ. 05/10/2005). However, the described laboratory does not provide the level of safety necessary for working with microorganisms of the I-II pathogenicity groups (highest in danger according to the classification of the Russian Federation).

The Laboratory of Sanitary and Hygienic Research, also described in the patent for utility model of the Russian Federation No. 65434, IPC B60P 3/00, publ. August 10, 2007. The laboratory is mounted in a van on the basis of a special trailer for the KAMAZ automobile and contains a hermetically sealed interior with a biological safety level BSL-2, with a forced-air and exhaust ventilation system and life-support equipment. The laboratory interior is divided by airtight partitions into a functional compartment designed for sanitary and hygienic studies and a sanitary inspection room. The biological material is received and transferred to the research compartment through the hatch window mounted in the emergency exit door. The interior of the laboratory is equipped with all necessary equipment for sanitary research. The laboratory is equipped with an audible alarm, means of a visual electrical control system for the operation of the filtering installation, and means of notification of the operating mode. The disadvantage is that due to the installation of the laboratory on the basis of a car trailer, its body undergoes intense vibrations and deformations when the car is moving, especially when the car is moving on rough terrain and in off-road conditions, as a result of which the interior can be leaky and the laboratory personnel are infected , for example, by means of contaminated air penetrating from outside into the interior of the laboratory.

A stationary biological laboratory for working with microorganisms of the I-II pathogenicity (danger) groups was chosen as a prototype, as the closest in technical essence, the description of which is given in the official document “Sanitary and epidemiological rules. Safety of work with microorganisms of I-II pathogenicity (danger) groups. SP 1.3.1285-03 ”, clauses 2.3, 2.4, 2.7, general and additional requirements for the premises and equipment of laboratories. The stationary laboratory is located in a separate building (or in an isolated block of the building) and is built from standard building materials: brick, cinder block, reinforced concrete panels using cement mortar. The laboratory is provided with the following systems: plumbing, sewer, electric power, heating, ventilation, lighting, telephone. The laboratory room is divided into two zones - “clean” and “infectious”. In the "clean" zone there is a wardrobe, a relaxation room, a room for working with documents, a sterilization room, a room with a refrigerator, a utility room, and a manager’s office. In the “infectious” zone there is a unit for working with infected animals, a research room, a glove box, a room for primary processing of materials, and an autoclave. Between the "clean" and "infectious areas there is a sanitary inspection room. The disadvantage of the prototype, which is inherent in most rooms made of general building structures, is that due to the natural precipitation of the building’s foundation, temperature extremes and humidity, as well as other factors, microcracks appear in the walls and ceiling of the laboratory premises through which microorganisms from »Zones may penetrate laboratory building structures and fall outside the laboratory, which is unacceptable. Ensuring impermeability for microorganisms of building structures is an extremely difficult and laborious task, requiring the use of labor-intensive protective materials and constant testing with the involvement of regulatory authorities, etc. Thus, the execution of the laboratory from general building structures does not provide adequate protection against the possible penetration of microorganisms into the environment Wednesday

The problem solved by the utility model is the creation of a highly protected biological safety module that meets the requirements of regulatory documents on the safety of working with microorganisms of pathogenicity groups I-II for carrying out research work in stationary conditions.

The solution to this problem is achieved by the fact that in the biosafety module containing a hermetically sealed functional box and an adjoining gateway with a sealed entrance door, communicating with each other via a sealed door and equipped with life support equipment, including energy supply, water supply, sewage, heating, air conditioning systems, forced supply and exhaust ventilation, equipped with fine filters, and the communication system are functionally and structurally interconnected with each other, while the functional box is equipped with a biosafety glove box connected via an air duct and fine filters of the removed air to a separate exhaust ventilation unit, diagnostic equipment and preparations for microbiological and chemical analyzes, as well as toxic studies and a transfer window made in the form of a closed airtight chamber with airtight doors installed on the outer and inner sides relative to the function national boxing, according to the utility model:

- the biosafety glove box complies with category BSC-III;

- the enclosing structures (walls, ceilings, doors, windows) of the functional box and airlock are made on a rigid supporting frame of steel thin-walled rectangular racks, closed in the transverse direction by rigid crossbars and shoulder straps, which ensures the invariance of the spatial geometric dimensions of the functional box and airlock for the whole time operation.

- walls and ceilings, a functional box and airlock are made in the form of two-layer steel panels with heat and sound insulating material installed between the layers, while the tightness of the functional box and airlock is ensured by each of the layers of wall and ceiling panels, as well as a labyrinth connection of the ceiling and wall panels with a rigid supporting frame ;

- the joints between the walls and the ceiling, between the walls and the floor of the functional box and the gateway are made tight around the perimeter;

- the floor of the functional box and airlock is made bulk from a wear-resistant antistatic polymer material;

- the functional box is equipped with an additional hermetic transfer window, while the chamber cavity of the additional transfer window is in communication with a separate supply and exhaust ventilation system with fine filters for the supply and exhaust air from the chamber;

- locking mechanisms of the glove box doors, transfer windows, doors between the functional box and the gateway and the gateway doors are made in such a way that when you open any of them, the locking mechanisms of the rest are locked in the closed state;

- on the ventilation ducts of the glove box, functional box, gateway and additional transfer window, control and sealed shut-off valves are installed;

- the opening of the duct for supplying ventilation of the functional box is located in one of its corners, and air intake by exhaust ventilation of the functional box is carried out in the diagonally opposite corner of the box, and the entrance door of the functional box is located in the area of the opening of the duct of the duct for supplying ventilation;

- the supply air distributor is hermetically integrated into the wall with the front door and / or into the ceiling near the wall with the front door, air intake is carried out through the intake ventilation duct (s), hermetically integrated (s) into the opposite wall and / or to the ceiling near the opposite wall of the functional box;

- the pressure values created by the ventilation system in the glove box, functional box, additional transfer window and gateway satisfy the inequalities

P _PB <P _FB <P _W <P _OCD and P _FB <P _DPO <P _OCD , where

P _ПБ - pressure value in the glove box;

P _FB - pressure value in the functional box;

P _DPO - pressure value in an additional transfer window;

P _Ш - pressure value in the gateway;

P _OCD - atmospheric pressure outside the biosafety module.

In addition, bactericidal irradiators are installed in the glove box, transfer window chambers, functional box and airlock.

In addition, a system for restricting access to the inside of the module is installed on the airtight entrance door of the gateway.

In addition, a sink and a sealed cabinet are installed in the lock room.

In addition, differential pressure sensors are installed in the functional box and the gateway.

In addition, an opening was made in one of the walls of the functional box for hermetically docking the autoclave to it.

In addition, the glove box is installed against the wall of the functional box, opposite the wall with the front door of the box.

The essence of the claimed technical solution is illustrated in figure 1, which schematically shows a biosafety module (top view) with the relative position of the main systems of its equipment, and in figure 2, which shows a transverse section of the wall and ceiling panels.

The biosafety module (see Fig. 1) contains a hermetically sealed functional box 1, in which work with microorganisms and other studies is performed, and an adjoining gateway 2 with a sealed entrance door 3. In the gateway 2, personnel can change their clothes and perform the necessary hygiene procedures . The functional box 1 and the gateway 2 communicate with each other by means of a sealed door 4. The directions for opening the doors 3 and 4 are shown by arrows. The biosafety module is equipped with life support equipment, including an energy supply system (wiring, sockets, switches, lighting lamps, etc., not shown in FIG. 1), a water supply system (water pipes, valves, water taps, etc., on 1 is not shown), a sewage and heating system (sewer pipes, a container for collecting water and liquids, elements of a heating system, for example, heating batteries, are not shown in FIG. 1), an air conditioning system (not shown in FIG. 1) which is combined with sis subject of forced ventilation, forced supply and exhaust ventilation system. The diffuser 5 of the supply ventilation of the functional box 1 (located on the ceiling of the functional box 1) is connected by an air duct to the filtering device 6 with fine filters. As fine filters, HEPA filters with a degree of air purification of 99.995% from particles with a size of 0.3 microns are used. Exhaust ventilation of the functional box 1 consists of a filtering device 7 and filtering elements located inside the device 7, which also use HEPA filters. Through the duct connected to the filtering device 7, the cleaned air leaves the limits of the functional box 1. The gateway 2 also contains a duct and a fresh air diffuser 8 and an exhaust diffuser 9, which are also equipped with fine filters (not shown in Fig. 1). The communication system includes intercoms 10, through which communication can be made between the gateway 2 and box 1, as well as with personnel located outside the module (from the outside of the gateway 2). Functional box 1 is equipped with a glove box 11 of biological safety of category BSC-III for work with microorganisms of I-II pathogenicity groups. The glove box 11 is connected via an air duct 12 to a separate exhaust ventilation unit (not shown in FIG. 1) having fine filters for air to be removed from the box 11. The door 4 of the functional box 1 and the glove box 11 are located at opposite walls of the box 1, and the hole (diffuser) of the supply ventilation 5 and the intake opening of the exhaust ventilation filter device 7 are located in diagonally opposite corners of the box 1, and the entrance door 4 is located in the area of the opening (diffuser) 5 of the supply vein tilation. This is done so that the door 4 gets as little air as possible from the area of the glove box 11 (the movement of ventilated air in box 1 is shown by a long arrow). A similar arrangement of the inlet 8 and the exhaust vent 9 is adopted in the gateway 2 for the same purpose. Functional box 1 is also equipped with diagnostic equipment located on tables and shelves (not shown in FIG. 1) for conducting microbiological and chemical analyzes and toxicological studies. In addition, in box 1 there are two transfer windows 13 and 14, made in the form of sealed chambers with sealed doors 15 and 16 at the window 13 and 17 and 18 at the window 14. The additional transfer window 14 has a separate forced air supply 19 and exhaust 20 ventilation, equipped with fine filters for supply and exhaust air type HEPA. The transfer window 14 is intended for transfer to box 1 and from it especially dangerous materials and preparations with microorganisms. The premises of boxing 1, gateway 2, the working area of the glove box 11 and the chambers of the transfer windows 13 and 14 are equipped with bactericidal irradiators 21 (ultraviolet lamps). The locking mechanisms of the doors 4 and 3, as well as the doors of the transfer windows 15, 16, 17 and 18 and the doors of the transfer lock (not shown) of the glove box 11 are made in such a way that when any of the doors are opened, the locks of all other doors and doors are locked in position "closed". This can be done using electromechanical devices and is designed to eliminate the possible leakage of microorganisms outside the functional box and ensure safety. On the air ducts 12 of the glove box 11, the supply ventilation 5 and exhaust ventilation 7 of the functional box 1, the supply 8 and exhaust 9 ventilation of the gateway 2 and the supply and exhaust ventilation 19 and 20 of the additional transfer window 14 are installed regulating (to ensure the specified flow rates and pressure) and tight shut-off valves (valves not shown in FIG. 1), which are used to exclude air from the box 1, gateway 2, glove box 11 and an additional transfer window 14 with the environment when replacing fine filters. In the opening of one of the walls of the functional box 1, an autoclave 22 can be sealed for sterilization and treatment of contaminated instruments, equipment, laboratory glassware, etc. The walls 23 of the functional box 1, gateway 2 and the ceiling of both rooms are made of two-layer panels 24 (see figure 2) with heat-insulating material 25 installed between them. As panels 24, sheets of painted galvanized or stainless steel are used, as the material 25 is mineral wool. At the same time, the tightness of the rooms of boxing 1 and the gateway 2 is provided by each of the layers 24 of the wall and ceiling panels. The tightness of the joints between the panels is provided by their labyrinth connection with the uprights and crossbars of the frame (see figure 2). The floor of the functional box 1 and the gateway 2 is made bulk from a wear-resistant antistatic polymer material, providing air and moisture resistance of the floor. All joints between the walls and the ceiling and the walls and floors are sealed around the perimeter, which is achieved using silicone sealants. The coloring properties of the walls, ceiling and floor surface, silicone sealant allow their repeated washing and cleaning with disinfectants. The pressure values created by the ventilation system and control valves in the glove box 11, the functional box 1, the additional transfer window 14 and the lock 2 change stepwise, for example, after 20 Pa and in any of the listed volumes the pressure value is less than the ambient pressure. This is necessary so that the air flow from the transfer windows and through the doors of the box 1 and the gateway 2 is directed only inside the box 1, and the air from the glove box 11 does not enter the box 1, which ensures the safety of work with highly pathogenic microorganisms and the environment. In the developed prototype of the biosafety module, the following pressure differences are created (relative to the ambient pressure):

- minus 90 Pa in the glove box;

- minus 60 Pa in a functional box;

- minus 40 Pa in an additional transfer window;

- minus 30 Pa in the gateway.

Minus means sparseness of the environment relative to the environment. The front door 3 of the gateway 2 may be equipped with an access restriction system 26, i.e. You can enter gateway 2 only by a special card with a magnetic code, a picture of a papillary finger pattern, etc. Inside the airlock 2, a sealed cabinet 27 can be installed to accommodate clothes and means for disinfection and cleaning, and a sink 28 for washing hands. The differential pressure in box 1, glove box 11 and gateway 2 can be monitored using differential pressure sensors 29. A biosafety module or a set of biosafety modules is installed inside the original enclosed space (not shown in FIG. 1). For natural lighting of the box 1 and the gateway 2, sealed windows 30 are provided.

Preparation of the biosafety module for work and work in it is as follows. In temperature control box 1 and gateway 2, comfortable temperature conditions are created using the heating system, lighting and bactericidal irradiators 21 are turned on in glove box 11, box 1, gateway 2, transfer windows 13 and 14 and the autoclave 22. After the required period of time is required for sterilization of air in the indicated rooms and chambers, the forced exhaust system (at the beginning) and the supply (after 10 ... 20 seconds) ventilation systems 6, 7, 8, 9, 19 and 20 are turned on, with the help of which the required pressure drops in the glove box, chambers are created x transfer windows, box 1 and gateway 2, which are controlled by differential pressure sensors 29. After that, using an access restriction system, for example, a magnetic card, the staff opens the door 3 of the gateway 2 and enters it, closing the door 3, conducts (if necessary) hygienic procedures using a sink 28 and change clothes (if necessary), folding clothes in a sealed closet 27. Then, opening the door 4, the staff enters the functional box 1, in which, having received the necessary preparations and samples through the transfer windows 13 l Bo 14 and closing the doors of the transfer windows, puts them into the glove box 11 and conducts the necessary work and research with them using a certain set of instruments and diagnostic equipment located both inside the glove box 11 and inside the functional box 1. At the end of work in the premises bactericidal irradiators 21 are turned on, the glove box and transfer windows, then the spent materials are removed from the glove box 11 and placed (if necessary) in the autoclave 22, where they are disinfected Contents. After that, the spent materials can be transferred through the transfer windows 13 and 14 to the outside of the biosafety module. The staff moves from box 1 to gateway 2, makes the necessary hygiene procedures using sink 28, changes clothes and exits through biosafety module 2 through door 3 of gateway 2. Then, after cleaning and disinfection of surfaces and personnel leaving the premises of the biosafety module, an additional disinfection of air and surfaces with bactericidal irradiators 21 is carried out and the supply and exhaust ventilation system is switched from the operating mode to the standby mode with reduced air productivity.

The proposed design of the biosafety module, having a high degree of tightness of the wall, ceiling and floor panels, and a cascade differential pressure between the module rooms, the glove box, the transfer window and the environment, as well as the locking mechanisms of the doors and doors of the transfer windows that lock the locks in the “closed” state »When you open any of the listed doors, it provides a very high degree of environmental protection in the event of the entry of microorganisms into the air of a functional box. Tests of the prototype showed that the design of the biological safety module meets the requirements of regulatory documents for work with microorganisms of pathogenicity groups I and II.

Given that the claimed technical solution has novelty, distinguishing features and industrial applicability, the applicant believes that it can be protected by a patent for a utility model.

Claims (7)

1. The biosafety module for working with microorganisms, containing a hermetically sealed functional box and an adjoining gateway with a sealed entrance door, communicating with each other via a sealed door and equipped with life support equipment, including energy supply, water supply, sewage, heating, air conditioning, and forced-air supply systems and exhaust ventilation, equipped with fine filters, and a communication system, functionally and structurally interconnected, with This functional box is equipped with a biosafety glove box, connected via an air duct and fine filters of the removed air to a separate exhaust ventilation unit, diagnostic equipment and preparations for microbiological and chemical analyzes and toxicological studies, and a transfer window made in the form of a closed sealed chamber with sealed doors installed on the outer and inner sides relative to the functional box, characterized in that the biological safety glove box corresponds to category BSC-III, the walls and ceilings of the functional box and airlock are made in the form of two-layer steel panels with heat and sound insulating material installed between the layers, while the tightness of the functional box and airlock is ensured by each of the layers of the wall and ceiling panels, the joints between the walls and the ceiling are sealed around the perimeter, the floor of the functional box and airlock is made bulk from a wear-resistant antistatic polymer mat Rial, the joint between the floor and the walls is sealed around the perimeter of the functional box and the gateway, the functional box is equipped with an additional sealed transfer window, while the chamber cavity of the additional transfer window is in communication with a separate supply and exhaust ventilation system with fine filters for the supply and exhaust air from the chamber , locking mechanisms of the glove box lock doors, transfer window doors, doors between the functional box and the lock and the lock entrance door are made in this way m, that when opening any of them, the locking mechanisms of the rest are locked in the “closed” state, control and tight shut-off valves are installed on the ventilation ducts of the glove box, functional box, lock and additional transfer window, the opening of the duct for supplying ventilation to the functional box is located in one of its corners, and air intake by exhaust ventilation of the functional box is carried out in the diagonally opposite corner of the box, and the entrance door of the functional box is located and a duct hole location ventilation zone and the quantities produced by the ventilation system pressures in the glovebox, the functional box, the gear box and the further gateway satisfy inequalities R _PB <R _FB <R _W <R _OCD and R _FB <R _DPO <R _OCD , where R _PB - the pressure in the glove box; P _FB - the pressure in the functional box; R _DPO - pressure in the additional transfer window; R _W - the pressure in the gateway; R _OCD - atmospheric pressure outside the biosafety module. 2. The biosafety module according to claim 1, characterized in that bactericidal irradiators are installed in the glove box, transfer window chambers, functional box and airlock. 3. The biosafety module according to claim 1, characterized in that a system for restricting access to the inside of the module is installed on the airtight entrance gateway door. 4. The biosafety module according to claim 1, characterized in that a sink and a sealed cabinet are installed in the gateway room. 5. The biosafety module according to claim 1, characterized in that differential pressure sensors are installed in the functional box and the gateway. 6. The biosafety module according to claim 1, characterized in that in one of the walls of the functional box there is an opening for hermetically docking the autoclave to it. 7. The biosafety module according to claim 1, characterized in that the glove box is installed against the wall of the functional box opposite the wall with the front door of the box.