TECHNICAL FIELD

The subject of the invention is a highly mobile container laboratory in compliance with Biological Safety Level 4 (BSL-4) standard, suitable for the analysis of infecting agents, which comprises the laboratory, service and engineering systems necessary for fully autonomous over 24 hrs operation in a single unit.

The laboratory can be used in all cases when the particularly rapid processing of the samples of mainly tropical pathogens is required near an infection site where no infrastructural facilities are available on the spot. BACKGROUND AND PRIOR ART

It is well-known that the safety of the environment and the operators of laboratories used for the analysis of infectious pathogens, and the minimisation and elimination of the risk of infection are ensured by the biological safety level (BSL) of laboratories , the requirements and specifications of the biological safety system assigned to the specific level and compliance with these. The observance of biological safety and ensuring its observance by all operators is an essential requirement for each laboratory where microbiological agents (microorganisms) constitute the subject of the tests either for diagnostics or research. Deployable highly mobile laboratories capable of autonomous operation used for the diagnostics of infectious agents are in great demand primarily in difficult-to-access tropical areas with a less advanced medical background, where several extremely infectious pathogens cause frequent and widespread epidemics. Such laboratories have a particularly great significance in the wake of natural disasters, when the extensive and sudden collapse of infrastructure has an impact on large masses of people in the disaster area and the probability of the outbreak of epidemics rises dramatically. The development of highly mobile container laboratories with autonomous capabilities and a higher biological safety level started with great intensity after the bioterrorism attacks of 2001. Several countries in Europe engineered equipment of restricted application capabilities for military purposes. In fact the US army has several deployable laboratories, but these are suitable for clearly defined military applications only. Among others, France, Sweden, Finland, Slovenia, Spain and Poland have such laboratories (these were presented in restricted military events and technical displays held at professional conferences, e.g. the 2nd International Scientific Conference EpiMilitaris 2013 - Bioterrorism, 9-12 September 2013, Ryn, Poland, and the 10th CBW Protection Symposium, 8-11 June 2010, Stockholm, Sweden). A specific feature of these laboratories is that they were developed by the defence industry engineering companies of the armies in the countries mentioned. For example, such a product is described on the website http://www.em-tronic.si/sites/emtronic/files/P107- 11 ENG%20BIOLAB%20prospekt.pdf. Developments for civilian use are conducted in relatively few countries as civilian health care and public health disaster relief organisations do not have adequate funds for the procurement and operation of deployable laboratories. These civilian laboratories are frequently used by the military in such countries. Data about such laboratories are presented in the websites on the Internet below:

http://www.germfree.com/category/product-lines/mobile-lab oratories/

http://www.orlando-systems.com davila.html

http://www.chem.agilent.com/Library/techjiicaloverviews/P ublic/5988-9152EN.pdf http ://www. indracompany. com/sites/default files/CBRN_Eng_0.pdf

http://www.certekinc.com products/READYPOD-Mobile-Laboratory/

http://www.tfdesign.co. za our-projects-products/cb-mobile-laboratory/?id=39&entryI d=125

These laboratories installed in a single container basically meet the requirements of Biological Safety Level 3, but they are not suitable for the safe handling of microorganisms requiring Biological Safety Level 4. Such laboratories are configured in accordance with similar principles, which are summarised below, pointing out the weaknesses and deficiencies of the known solutions: 00112

3

• In the laboratories known today, positive pressure is applied so that the laboratory could also function in an infected and contaminated environment. This is essentially contrary to the requirements of Biological Safety Level 4.

• Appropriate biological safety conditions are provided by a single-compartment glove box installed in the laboratory and, if the glove box is physically damaged, the pathogens from the laboratory space can be discharged into the environment through overpressure.

• Due to the single-compartment glove box, only one sample can be managed in the laboratory at any one time.

• The laboratories have their own power supply system (engine-generator) with no back-up, which represents a safety risk if the engine-generator fails.

• The glove box has an installed decontamination device, but the decontamination of the laboratory space is unresolved (there are no devices or procedures for this purpose).

Summarising the experience and observations above, it can be established beyond doubt that, although the known solutions to date have made efforts at creating universal laboratory containers with a high biological safety level, not one of these versions provides a complex solution that satisfies the highest requirements for laboratory conditions, Biological Safety Level 4.

Only a small number of publications contain information on Biological Safety Level 4 laboratories that can be assembled using two containers of different types and makes. These deployable versions do not satisfy the strict requirements of the high degree of mobility and easy transport, as the safety level is achieved through connecting several containers and wearing special, overpressure type laboratory protective clothing. A detailed description of such laboratories is presented in the following literature: http://www.honvedkorhaz.hu/cikk/560, andPaul Chui, Peter Chong, Bobby Chong, and Stefan Wagener: Mobile Biosafety Level-4 Autopsy Facility— An Innovative Solution. Applied Biosafety Vol. 12, No. 4, 2007, pp. 238-244. SUMMARY OF THE INVENTION

Therefore, the purpose of the invention is the establishment of a highly mobile, Biological Safety Level 4 container laboratory that can be easily deployed. The design must provide the full supply of devices, materials and energy for autonomous 24-hour operation.

The analysis of the requirements and the task to be solved led to the recognition that the simultaneous satisfaction of all the requirements necessitates the elaboration and flexible combination of three conceptual elements. First, we recognised that it is necessary to provide a structure which allows the optimisation of laboratory processes at the highest biological safety level within the accommodating body. Moreover, as the second conceptual element, it was found that space must be provided inside the container for all the sub-systems which ensure the simultaneous satisfaction of the requirements necessary for laboratory processes at Biological Safety Level 4. It was also recognised that, as a third conceptual element, it is necessary to install a multi-segment glove box system with autonomous air circulation and the possibility of dividing into sections, which is totally different from the earlier systems and provides the best possible isolation of the infectious samples from the laboratory space and staff. On base of the recognitions above, the invention is a highly mobile container laboratory in compliance with Biological Safety Level 4 (BSL-4) standard, suitable for the analysis of infecting agents, which comprises the laboratory, service and engineering systems necessary for fully autonomous over 24 hrs operation in a single unit, which has an accommodating container of special layout and configuration, which is built on an expandable frame structure of an unique design, with the core of the frame structure being the integrated laboratory space 2, an space expandable unit with rigid walls, which is in a closed position of the container surrounds the integrated laboratory space 2, the decontamination shower 5 and the directly connected engineering elements 3, 4 and in an open position, the service compartment 7 created in the expandable unit providing access to the information technology and control units 6 necessary for operation, as the second element, it comprises a plurality of interconnected engineering safety and service sub-systems configured in a unique manner in the container, as the third element it comprises a special glove box system, in which two glove box modules 26, 27 and the interconnecting transfer boxes 28 are incorporated, and a blow-in system provided with high-efficiency particulate air filters 29, exhaust devices 30 and the decontamination system 31, which can be operated and controlled from the laboratory compartment 2.

A preferred method of construction of the container laboratory pursuant to the invention, and within that the interconnected engineering safety and service sub-systems, is presented in the attached Figure 3 and/or Figure 4.

A further advantageous version of the container laboratory pursuant to the invention, and within that the design of the accommodating container, is presented in the attached Figure 1 and Figure 2.

A further version of the container laboratory according to the invention comprising the design of the special glove box system is presented in the attached Figure 5.

BRIEF DESCRIPTION OF THE DRAWING

Figure 1 - shows the container 3D drawing, closed state without ceiling

Legends: 1 engineering element

2 laboratory space

3 engineering element

4 engineering element

5 decontamination shower

6 IT and control unit

8 entrance

9 material input and output route

Figure 2 - shows the container 3D drawing, opened state without ceiling

Legends: 1 - engineering element

2 - laboratory space

3 - engineering element

4 - engineering element

5 - decontamination shower

6 - IT and control unit

7 - service compartment 8 - entrance

9 - material input and output route

10 - decontamination shower room door

11 - laboratory door

Figure 3 - shows the container 3D drawing, opened state without ceiling, with engineering elements Legends: 6 - IT and control unit

8 - entrance

10 - decontamination shower room door

11 - laboratory door

12 - glove box system

13 - autoclave

14 - laboratory furniture

15 - air blow-in

16 - air exhaust

17 - air condition device

18 - hydrogen fuel cell

19 - hydrogen gas container

20 - uninterrupted power system

21 - water and waste water system

Figure 4 - shows container 3D drawing, opened state with ceiling, without back side wall, with engineering elements

Legends: 2 - laboratory space

9 - material input and output route

15 - air blow-in

16 - air exhaust

17 - air condition device

18 - hydrogen fuel cell

20 - uninterrupted power system

21 - water and waste water sytem

22 - engine-generator

23 - decontamination system main unit

24 - pipe connections (air ventillation and air condition system)

25 - electric connections (AC/DC) Figure 5 - shows the glove box system

Legends'. 26 - glove box module 1

27 - glove box module 2

28 - transfer box

29 - blower

30 - exhaust

31 - decontamination system

DETAILED DESCRIPTION

An important element of our invention is the unique structural design of the laboratory container. It is obvious that Biological Safety Level 4 laboratory activity within a single structure is only possible by means of a our special configuration and layout.

We found that the accommodating container has a unique expandable frame structure design based on a 20-foot (ICC type) body in compliance with the provisions of the ISO standard. The structure of the accommodating container is presented in the closed (transport) and open (work) positions in Figure 1 and Figure 2. The core of the frame structure is constituted by the integrated laboratory space 2. In the closed position the expandable unit with rigid walls surrounds the integrated laboratory space 2, the decontamination shower 5 and the engineering elements 3 and 4 directly connected to the former. In the open position, the service area 7 created in the expandable unit provides access to the IT and control units 6 necessary for operation. The structural unit of the compartment which can be extended is integrally connected to the frame structure in both the open and closed (transport) positions. In the expanded position it is self-supporting, i.e. it requires no separate support. The extension of the expandable compartment is possible both electrically and mechanically. According to our invention, when designing and manufacturing the frame and the expandable unit, the interconnection of the main structural elements is secured (electrical and pipe connections 24 and 25 between the engineering compartments). In the embodiment of the invention additional important elements are the plurality of the interconnected engineering safety and service sub-systems installed in the container. The configuration of the individual sub-systems is presented in Figure 3 and Figure 4.

Concerning the integrated laboratory spaces, the conditions to be provided are regulated by the relevant biological safety specifications. The detailed requirements of the specific biological safety levels are included in the CDC BMBL5 Manual (US Department of Health and Human Services Public Health Service, Centers for Disease Control and Prevention and National Institute of Health: Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, 2007). This system of requirements is the compendium of specifications for biological safety laboratories applied and accepted worldwide.

The embodiment of our invention specified herein is in full compliance with the specifications indicated above and approved internationally. However, at the same time, it provides novelties and specific additional impacts through the configuration of the subsystems installed in the cabinets of specific structures in accordance with the following; as it comprises:

• isolated, air-tight laboratory room 2,

• double-door entrance (air-lock 5 with decontamination shower ), with interlocking doors 10, 11 which cannot be opened at the same time,

• isolated personal entrance and exit 8, 10, 11 and material input and output routes 9,

• an interior design allowing complete disinfection (gap-free surfaces and furniture 14 made of materials resistant to disinfectants),

• our 'glove box laboratory' has a segmental glove box system 12 with autonomous air circulation with transfer boxes providing total isolation for infectious agents,

• removal of hazardous waste from the laboratory is only possible after decontamination through the use of an autoclave for waste disposal 13,

• waste water classified as hazardous waste 21 can be treated, collected separately and neutralised chemically,

• automated laboratory space and glove box type decontamination processes, High Efficiency Particulate Air filter (HEPA filter) and filtered exhaust air 16, negative air pressure in the laboratory space with air pressure stages decreasing towards the laboratory area as well as directed, single direction air flow 15, 16 and air conditioned area 17,

continuous, uninterrupted electric power supply during the entire operation of the laboratory with synchronised equipment operating on different principles and capable of backing up each other (engine-generator 22, hydrogen fuel cell 18, 19, uninterrupted power supply system with batteries 20),

appropriate laboratory protective clothing to be used (air protection device, coverall and rubber gloves),

monitoring of the staff from outside the laboratory using the IT system 6 (camera system, communication system) feasible.

The third element of the containerised laboratory according to the invention comprises the special glove box system. The requirements relevant to Biological Safety Level 4 laboratories as well as the solutions currently applied in container laboratories were reviewed and it was found that the total isolation necessary for the high biological safety level in a single container can be best achieved by means of a special glove box system 12. Every work process in the laboratory which is carried out by handling live and infectious microorganisms is carried out within the glove box system, which means that no infectious agents can get into the laboratory space.

The layout of the glove box system is illustrated in Figure 5. The glove box system 26, 27 of unique design installed in the container comprises two glove box segments and the transfer boxes 28 interconnecting them, a total of 5 elements. Every single element is provided with a separate selectable air supply and air ventilation unit, so, if one segment fails, the others are still available for the safe implementation of the laboratory processes. Every element is equipped with a blow-in 29 and two exhaust HEPA filters 30. This ensures the sterile air supply necessary for work in the boxes and that the air discharged from the boxes does not contain infectious microorganisms either. The air flow is laminar and unidirectional in the boxes, allowing the simultaneous handling of several samples including different microorganisms and avoiding cross-contamination. The double decontamination system 31 operated from the laboratory space is installed in every element of the glove box cabin. The first system ensures the rapid flooding of the boxes with disinfection aerosol in the event of a spill of infectious agents below the boxes. The second system - after the activities below the boxes are completed - floods their air spaces by gas for the full sterilisation of the air spaces, surfaces and filters.

The operation of the container which is the subject of the invention could be described in detail by an extremely complex set of documents. Operation is accomplished through the extremely complicated simultaneous actuation and supervisory control of the engineering, control, safety and laboratory systems of devices and operations. The processes are controlled by an automatic control unit and software custom-designed..

Finally, we summarise the advantageous effects of the Biological Safety Level 4 laboratory established in the container - according to our invention - as follows: - with respect to laboratory technology, a solution is provided for the application of expandable structures also usable for microbiological purposes,

- functionally, an accommodating structure has been created which simultaneously ensures the availability of both the laboratory space, and the service and engineering compartments necessary for performing medical functions, - through the invention, from the aspect of biological safety, the complete air- tightness of the integrated laboratory space can be ensured in the case of negative pressure conditions as well,

- from the biological safety aspect, the full isolation of the infectious samples can be secured by means of the individual glove box system integrated in the laboratory, and

- the container designed for autonomous 24-hour operation promotes rapid emergency action for handling epidemiologically critical situations.