RU2615432C1 - Aseptic isolated unit - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to production of vaccines using pathogenic biological agents (PBA) and can be used for design of isolated aseptic processing facilities for medical, pharmaceutical and microbiological industry. The unit comprises enclosing constructions of the existing facilitit, supply and exhaust ventilation system with high efficiency filters, collapsible building envelope, sealed doors, clean area, downcoming channel filter. Operating facilities including isolation ward premises followed by pre-isolation ward premises, barrier zone premise comprising a controlled barrier zone premise, service premise and vestibule are constructed inside the enclosing structures of the existing facility, on its floor, by means of the sealed mobile enclosing structures. The front wall of the isolation ward and side walls of the unit are adjacent to the ceiling of the existing premises. The controlled barrier zone premise is formed by the front wall of the isolation ward, part of the unit side walls and the outer wall of the existing building. A pass box is installed in the peripheral wall of the isolation ward. The pre-isolation ward premise is shorter than the isolation ward, forming together with a part of the isolation ward peripheral wall, a part of the unit lateral wall and the pre-isolation box side wall a passage to the pass box in the peripheral wall of the isolation ward. The shared ceiling of isolation ward and pre-isolation ward premises is made below the ceiling of the existing premises, forming a ceiling cavity above these two premises with an access provided to the ceiling cavity from the service premise. Service premise entrance is equipped with an entrance vestibule with sealed mobile enclosing structures adjacent to the inner wall and ceiling of the existing premises. A downcoming channel, equipped with a high efficiency filter is located at the top of the sealed mobile enclosing structures of the vestibule; the channel connects the vestibule to the service premise. The corner air intake module of the service premise is connected to the air intake duct of the supply ventilation system. The service premise is connected to the controlled barrier zone premise by a downcoming channel equipped with a high efficiency filter and installed in the upper part of the front wall of the isolation ward premise. Air supply ducts of the supply ventilation system in the vestibule, service premise, isolation ward and pre-isolation ward premises are equipped with stand-alone air-distributing modules with high efficiency filters. The sealed door on the peripheral wall of the pre-isolation ward and the sealed door on the peripheral wall of the isolation ward are maximally displaced relatively to each other.

EFFECT: invention provides a possibility to block a possible exit of PBA-contaminated air environment from the isolation ward to the pre-isolation ward and into the surrounding atmosphere, the required class of ambient air cleanliness in the working area of isolation ward and pre-isolation ward at a regulatory regime of air dilution, as well as energy saving in terms of heat (cold) of ambient air in the service premise and vestibule.

5 cl, 5 dwg

Description

The invention relates to the production of vaccines using pathogenic biological agents (hereinafter referred to as PBA) and can be used in the design of aseptic (clean) isolated technological premises for the medical, pharmaceutical, microbiological industry.

Known design of the premises for working with radioactive substances, containing equipment zone, repair and transportation zone, operator area [Krupchatnikov V.M. Ventilation when working with radioactive substances. M., Atomizdat 1968]. The main disadvantage is the non-sterility of the technological process and the inability to provide various modes of pressure differences (vacuum) of the ventilation air in the premises of the working area.

An experimental technological box is described (RU 2375641 C2 op. 10.12.2009). It contains a room for the boxing working area, a transition zone room, a common supply ventilation system equipped with control valves with an air supply duct for supplying fresh air directly to the upper part of the transition zone, adjustable supply and exhaust devices, corner ducts, sealed building envelopes for the working area and transition zones with suspended ceilings, insulated ceiling chambers of the premises of the working zone and transition zone, communicated with the corresponding The existing room through their corner ducts and adjustable air intake devices installed in their lower part, ceiling filter chambers installed in a suspended ceiling, fine filters, a stand-alone supply fan with a pressure duct, a stand-alone exhaust fan, the intake pipe of which is connected to an insulated ceiling chamber premises of the working area, characterized in that the air duct for supplying ventilation air is made in the form of a tee, with the possibility of supplying ventilation air both in the insulated supply chamber of the transition zone room and in the transition zone room, the intake pipe of the stand-alone supply fan is connected to the insulated ceiling chamber of the transition zone room and is configured to collect the transition air of the supply zone into the ceiling chamber of the room and to supply it in transit through the duct into the working area through the ceiling filter chamber, on the pressure duct of the autonomous exhaust fan vlyayuschy pipe with a control valve and communicating with insulated ceiling camera transition zone of the room. In the transition zone room and its ceiling chamber, air coolers are installed to cool the incoming air.

But this technical solution has a significant drawback - the constructive solution of this box does not meet the current regulatory requirements when working with PBA, hazardous to human health [1-3].

The closest analogue is an isolated cleanroom of a flexible technological system (RU 2017525 C1, Grigoryev V.V., 15.08.1994 - prototype). An aseptic insulated unit containing collapsible building envelopes installed inside the building envelope of an existing building, an overflow channel with a fine filter, supply and exhaust ventilation systems, and sealed doors.

However, this isolated cleanroom has a number of disadvantages in ensuring the existing requirements for ensuring biological safety [1-3], it does not provide for: a pre-box room; service room for staff training and equipment; vestibule gateway to enter the service room; free access to the gray area for maintenance, cleaning and disinfection of their surface and equipment located in it; protection against unauthorized release into the surrounding atmosphere of viruses and biologically active particles less than 0.1 microns in size; local shelter with appropriate biological protection of working personnel from contact with PBA, when performing technological manipulations with them, and removal and additional cleaning of air entering the box from the working chamber of the local shelter; technological solution for transferring materials directly to the working area of the box. In addition, there is no saving in energy costs for creating air exchange in auxiliary rooms.

The present invention is directed to a block devoid of these disadvantages.

The technological result is to block the possible exit of contaminated PBA of the air from the boxing room to the prebox, service room, the premises of the controlled barrier zone and into the surrounding atmosphere, to ensure the required class of cleanliness of the air in the boxing and preboxing working zone under the normative regime of rarefying their air environment. An energy-saving technological solution for the use of heat (cold) of the air of the premises of the barrier zone.

The patented aseptic insulated unit contains mobile sealed enclosing building structures installed inside the building envelope of the existing building, the sealed closed circuit of which forms the isolated aseptic premises of the working area of the isolated aseptic unit, which consists of the box and pre-box premises, which are under the normative dilution of clean air [1, 2 ], and a barrier zone consisting of a service room, a controlled ba room ernoy input zone and locks, under regulatory excess pressure with clean air environment.

Mobile sealed side walls of an aseptic insulated unit are adjacent to the ceiling, the outer and inner walls of the existing premises.

The mobile sealed frontal wall of the box adjoins the ceiling of the existing room, forming with the part of the sealed mobile side walls of the aseptic insulated block and the outer wall of the existing room the room of the controlled barrier zone.

A transfer gateway is installed in the peripheral wall of the box.

The pre-boxing room is made shorter than the boxing room, forming with the part of the peripheral (back) wall of the box, part of the side wall of the aseptic isolated block and the side wall of the pre-box, a passage to the transfer gateway installed in the peripheral wall of the box.

The general ceiling of the box and the pre-box is made below the ceiling of the existing room, forming a ceiling cavity above the box and the pre-box with access to the ceiling from the service room.

The entrance to the service room is equipped with an entrance vestibule-gateway adjacent to the inner wall of the existing premises and a mobile side wall of the unit; a transfer channel with a control device and equipped with a high-efficiency filter is made in the upper part of the sealed mobile building envelopes of the entrance vestibule-gateway.

At the level of the general ceiling of the box and the pre-box, a collapsible design of the perforated ceiling was made to provide free access to the ceiling cavity of the service room and the box.

The angular intake module (RU 62220 U1, VV Grigoryev, February 13, 2006) of the service room is connected to the intake air duct of the supply ventilation system to ensure recirculation of the supply ventilation air supplied to the service room.

The service room is connected to the room of the controlled zone by a transfer channel equipped with a high-efficiency filter and a control device installed in the upper part of the frontal wall of the box, the transfer channel provides the ability to provide excess pressure of clean air in the room of the controlled barrier zone created in the service room.

Autonomous air distribution modules equipped with high-efficiency filters are installed on the air ducts of the supply ventilation system to the premises of the entrance vestibule, service room, pre-box and box. Autonomous filters of air distribution modules (RU 2335332 C1, Grigoryev V.V., April 6, 2004) have a dual function, i.e. as devices for supply air purification for aseptic rooms of the normative purity class and as devices blocking the overflow of air containing PBA between the above rooms in the event of an emergency on the supply and exhaust ventilation systems.

An ultraviolet irradiation unit is installed on the common air intake duct of the exhaust ventilation system in the room of the controlled zone to ensure proper decontamination of the removed air from the box and pre-box when working with viruses and biologically active substances with a particle size of less than 0.1 μm.

The air is removed from the premises of the pre-box, box and from the biological safety cabinet through self-contained high-efficiency filters installed in a controlled room of the barrier zone on their exhaust ducts, which will ensure reliable biological safety from possible overflows of contaminated air from the box to the room of the pre-box and its release into the surrounding atmosphere when an emergency occurs when one or both ventilation systems of the unit are disconnected.

The sealed door on the peripheral wall of the pre-box and the sealed door on the peripheral wall of the box are maximally offset from each other, which allows the pre-box [4] to be divided into rooms for transitional and technological clothes, the border of these rooms is a barrier bench installed in the center of the pre-box room.

The building envelopes of the existing building, inside which an aseptic insulated block is installed, are sealed, i.e. have regulatory breathability [3].

In FIG. 1 is a plan of a general view of an aseptic isolated unit.

In FIG. 2 - section C-C.

In FIG. 3 - section D-D.

In FIG. 4 - section E-E.

In FIG. 5 - section G-G.

The aseptic insulated block contains a boxing room A and a pre-boxing room B, a room for a controlled barrier zone B, a service room G, an entrance vestibule D, a corridor of an existing building Ж, enclosing building structures of an existing building, including the outer wall 1 of the existing room, the inner wall 2 of the existing rooms, floor overlap 3 of the existing room, ceiling 4 of the existing room, sealed mobile aseptic isolating building envelopes block, including sealed doors 5, the walls of the entrance vestibule-gateway 6, the side walls 7 of the aseptic isolated block, the front wall of the box 8, the peripheral (rear) wall of the box 9, the peripheral wall of the pre-box 10, the general ceiling of the box 11 and the pre-box, collapsible perforated ceiling 12 of the service room, ventilation equipment containing a coarse filter 13, air heater 14, fresh air fan 15, common fresh air intake duct 16, common fresh pressure air duct 17, thin filter purification 18, air cooler 19, air distribution modules 20 with high efficiency filters installed in them, angular air intake module 21 (RU 62220 U1) of the supply ventilation system, regulating device 22 of the supply ventilation system, exhaust fan 23, common intake air duct 24 of the exhaust ventilation system, pressure an air duct 25 of an exhaust ventilation system, an ultraviolet irradiation unit 26, control devices 27 of an exhaust ventilation system, an air intake device 28 of a cabinet oxa, box filter high efficiency 29, box high-efficiency filter 30 box, box 31 high-performance filter, box and corner box air intake modules 32 (RU 62220 U1), box 33 high-pass filter of the overflow channel of the controlled barrier area, filter 34 the inlet channel of the inlet vestibule, the inlet channel 35 of the inlet gateway, the inlet channel 36 of the controlled barrier area, the biological safety cabinet 37, the general ceiling cavity 38 of the service escheniya, boxing and predboksa, barrier bench 39, the transfer gate 40, the duct 41 of the air intake module corner room service, clothes transition space 42 predboksa, technological clothes room 43 predboksa.

Patented unit operates as follows.

Ensuring biosafety conditions.

Human and material flows.

The working and service unit with containers of the infected infected material is included in the vestibule D, close the entry compacted door 5 of the vestibule D from the corridor Zh, then open the sealed door 5, which is closed from the side of service room D, enter the service room D, install a container with infected material and all the necessary equipment and materials from service room D to the transfer gateway 40 and close its sealed door, then enter the transitional clothing room 42 prebox B, remove the transitional clothes, sit on the bench 39 barrier, relieve slippers, throws his legs over the bench barrier 39, then change into sterile technological clothes, and then enter the box room A.

Exit the box A premises in the reverse order.

Regulatory air exchange, overpressure and rarefaction modes, and ensuring the normative class of clean air in the premises of an aseptic isolated unit.

The external ventilation air through the air intake duct 16, after rough cleaning in the filter 13 and heating (in the cold season) in the air heater 14, is mixed with the air of the service room G, taken through its air intake device 21 (RU 62220 U1, Grigoryev V.V., 02/13/2006) and its duct 41 connected to the air intake duct 16, after which it is taken by the supply fan 15 and sent to the fine filter 18, and then to the air cooler 19, after which part of it goes back to the service room G and room the entrance tambour gateway D through the air distribution modules 20, equipped with high efficiency filters. Another part of it enters the premises of box A, pre-box B, having also undergone additional cleaning in high-efficiency filters installed in the air distribution modules 20.

The supply air that enters the room of the inlet gateway D through the air distribution module 20 creates excessive static pressure in it, which ensures its movement from the room of the transitional vestibule through the transfer channel 35 and its high-efficiency filter 34 to the service room D. Control devices 22 of the air distribution the device 20 and the transfer channel 35 of the tambour gateway, the standard value of the excess pressure of the air in the tambour gateway D is set, the value of which is greater than excess th air pressure of the service room G.

This technology simultaneously solves the problems of air exchange and the creation of excess pressure of the tambour lock and the reuse of the tambour lock cleared in the air filter for ventilation of the service room G.

The air exchange of the service room G is carried out in the following sequence: the external supply air is mixed with the air of the service room G removed from the above premises through the corner air intake module 21 (RU 62220 U1, Grigoryev VV, 02/13/2006) connected to the air intake duct 16 through the duct 41 of the intake module 21, then the air mixture is sent to all rooms of the aseptic isolated unit, including the service room.

The incoming supply air from the pre-B room B is removed from its lower zone through the corner air intake module 32 (RU 62220 U1, Grigoryev V.V., 02/13/2006) and, after subsequent cleaning in the high-efficiency filter 30 and ultraviolet block 26, sent to the atmosphere.

From the room of Box A, the supply air is partially removed from the lower floor zone through the corner air intake module 32, after which it is subsequently cleaned in the high-efficiency filter 29. Another part of the supply air from Box A is removed through the air intake device 28, which is installed in the box above the biological safety cabinet 37, after subsequent cleaning in a high-efficiency filter 31.

Using the regulating devices 22 of the supply ventilation system and the regulating devices 27 of the exhaust ventilation system in the room of box A and pre-box B, the normative rarefaction is established [3], while the magnitude of the vacuum in box A is higher than in pre-box B.

Regulating devices 22 of the air distribution device 20 and the transfer channel 35 of the tambour gateway set the standard value of the excess air pressure in the tambour gate D, the value of which is greater than the excess air pressure of the service room G.

Aseptic and comfortable conditions, the rate of air exchange in the service room G is carried out in recirculation mode. Regulatory devices 22 of the air intake module 21 and the air distribution module 20 in the service room G set the normative frequency of air exchange and the standard value of the overpressure of its aseptic air environment.

The standard purity of the supply air and the blocking of the overflow of the infected PBA air in the premises of the entrance vestibule gateway, the service room of the box and the pre-box is ensured by high-efficiency filters installed in the air distribution modules 20.

Excessive air pressure in the room of the controlled barrier zone B is ensured by the excess air pressure of the service room G transmitted to the room of the controlled barrier zone B through the transfer channel 36 of the room of the controlled zone and its high-efficiency filter 33.

The design of the angular air intake module, as known from RU 62220 U1, VV Grigoryev, 03/27/2007, and air distribution module 21, 32, described in patent RU 2335332 C2, Grigoryev VV, 10/10/2008, are not disclosed in this description. . The sign “high efficiency filter” involves the use of air filters that ensure the cleanliness of the supplied and removed air from microorganisms and mechanical aerosol particles with a protective efficiency of at least 99.995% for test aerosol with a size of 0.3 microns [5].

The invention provides the regulatory requirements for the biological safety of the human environment, working personnel, protection against contamination of the product and the correctness of the research work carried out in the proposed design of an aseptic isolated unit.

The energy costs of organizing regulatory air exchange in the premises of an aseptic isolated unit and the differential pressure regimes of the air in the rooms of an isolated aseptic and barrier zones are minimized.

The cost of construction of these aseptic isolated blocks during the design of new and reconstruction of existing buildings and the possibility of using domestic materials and equipment are significantly lower than the known domestic and foreign analogues.

Literature

1. SP 1.3.2322-08 “Safety of work with microorganisms of 3 and 4 groups of pathogenicity (danger) and pathogens of parasitic diseases”.

2. SP 1.3.3118-13 “Safety of work with microorganisms of the 1st and 2nd groups of pathogenicity (danger)”.

3. BCN 64-064-88 "Instructions for the construction design of enterprises of the medical and microbiological industry."

4. OST 42-510-98 “Rules for the organization of production and quality control of medicines.

5. GOST R 52539-2006 "Air purity in medical institutions."

Claims (5)

1. An aseptic insulated block containing the building envelope of the existing building, a supply and exhaust ventilation system with high-efficiency filters, collapsible building envelope, sealed doors, a clean area, an overflow channel with a filter, characterized in that it is overlapped inside the building envelope of the existing building its floor from a sealed mobile building envelope made the premises of the working area, containing the premises of the box and the next behind it the pre-box and the premises of the barrier zone, including the premises of the controlled barrier zone, the service room and the premises of the vestibule gateway; while the front wall of the box and the side walls of the aseptic insulated block are adjacent to the ceiling of the existing room; the room of the controlled barrier zone is formed by the front wall of the box, part of the side walls of the aseptic insulated block and the outer wall of the existing room, a transfer gateway is installed in the peripheral wall of the box, the pre-box is shorter than the box, forming part of the peripheral wall of the box, part of the side wall of the aseptic isolated block and the side wall of the pre-box passage to the transfer gateway installed in the peripheral wall of the box; the general ceiling of the box and the pre-box is made below the ceiling of the existing room, forming a ceiling cavity above the box and the pre-box with access to the ceiling from the service room; the entrance to the service room is equipped with an entrance tambour gateway, the sealed mobile enclosing building structures adjacent to the inner wall and ceiling of the existing building, a transfer channel equipped with a high-efficiency filter and connecting the tambour room is made in the upper part of the sealed mobile building envelope of the vestibule gateway with service room; the corner air intake module of the service room is connected to the air intake duct of the supply ventilation system; the service room is connected to the room of the controlled barrier zone by a transfer channel equipped with a high-efficiency filter and installed in the upper part of the front wall of the box; autonomous air distribution modules equipped with high-efficiency filters are installed on the air ducts of the supply ventilation system in the premises of the entrance vestibule, service room, pre-box and box; the sealed door on the peripheral wall of the pre-box and the sealed door on the peripheral wall of the box are maximally offset from each other. 2. The unit according to claim 1, characterized in that an ultraviolet irradiation unit is installed on the common air intake duct of the exhaust ventilation system in the room of the controlled area. 3. The block according to claim 1, characterized in that the pre-box room is divided by a barrier bench installed in the center of the room into a transitional clothing room and technological clothing room, respectively. 4. The unit according to claim 1, characterized in that an air intake device equipped with a high-efficiency filter is installed above the cabinet-box. 5. The block according to claim 1, characterized in that at the level of the general ceiling of the box and the pre-box, a collapsible perforated ceiling is made above the service room.

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