APPARATUS HAVING A PROTECTIVE ENVELOPE, USE THEREOF, AND METHOD FOR OPERATING A ROOM REGION
20230093603 · 2023-03-23
Inventors
- Udo GOMMEL (Stuttgart, DE)
- Frank BÜRGER (Stuttgart, DE)
- Daniel FALCH (Stuttgart, DE)
- Miroslav KOPCOK (Stuttgart, DE)
- Markus KELLER (Stuttgart, DE)
- Viola HOFFMANN (Stuttgart, DE)
Cpc classification
A61L2202/14
HUMAN NECESSITIES
F24F13/0218
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F24F3/167
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61L2202/21
HUMAN NECESSITIES
A23V2002/00
HUMAN NECESSITIES
F24F2011/0005
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61G10/005
HUMAN NECESSITIES
F24F13/0281
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F24F3/163
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F24F13/068
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61L2202/11
HUMAN NECESSITIES
International classification
F24F3/163
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61L2/00
HUMAN NECESSITIES
F24F13/02
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F24F13/068
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
Abstract
The invention is an apparatus having a protective envelope which is designed and constructed to envelope at least one room region, such that the protective envelope is able to separate the at least one room region from an environment immediately surrounding the protective envelope, and use thereof. Methods for operating a production engineering unit under cleanroom conditions and for creating and operating a virus-free and cross-contamination free room region surrounded by a protective envelope for accommodating persons and/or objects subject to quarantine. The invention has a protective envelope with at least two layers separated by a spacer layer, that is flow-permeable.
Claims
1-39. (canceled)
40. An apparatus comprising: a protective envelope enveloping and surrounding at least one room region which directly adjoins a floor area, the protective envelope separating the at least one room region from an environment surrounding the protective envelope; at least two layers including a first layer and a second layer separated by a spacer layer that spaces the first and second layers apart, the spacer layer being traversed by flow in a longitudinal direction through the spacer layer; at least one flow unit fluidically connected to the spacer layer; the first layer is permeable to flow, is mounted closest to the at least one room region and has a permeability to flow in the range from 500 to 49,000 m.sup.3/m.sup.2/h, the first and second layers are formed from only at least one material for directly enclosing a clean room of ISO classes 1 to 9 according to DIN EN ISO 14644-1:2016-06; that the protective envelope has an outlet area to which a sterilization unit is attached; and the at least one flow unit has an internal pressure formed inside the spacer layer which is greater than an inner room pressure formed inside the at least one room region which is greater than an ambient pressure in the environment surrounding the protective envelope.
41. An apparatus according to claim 40, comprising: a flow outlet from the at least one flow unit fluidically connected to the spacer layer and the protective envelope has an outlet fluidically connected to at least one flow inlet of the flow unit or a further flow unit.
42. An apparatus according to claim 41, comprising: a sterilization unit located inside at least one of the at least one flow unit and along a flow path between the flow outlet of the at least one flow unit and the spacer layer and along a flow path between the outlet and the flow inlet of the at least one flow unit or a further flow unit.
43. An apparatus according to claim 40, wherein the sterilization unit includes a UVC light source for creating a virus-free and biocontamination free air flow.
44. An apparatus according to claim 40, wherein the second layer has a flow permeability in a range from 0 to 100 m.sup.3/m.sup.2/h.
45. An apparatus according to claim 40, comprising: a third layer and a fourth layer which are separated by a further spacer layer, the third layer is connected to the second layer by a joint or the second layer and the third layer is a single part, the fourth layer is flow-permeable, and the further spacer layer is supported with a structure that spaces the third and fourth layers apart and is traversable by flow in the longitudinal direction of the third and fourth layers.
46. An apparatus according to claim 45, wherein at least one flow unit is fluidically connected to the further spacer layer.
47. An apparatus according to claim 45, wherein the first layer and the fourth layer comprise a material with identical material properties, the second layer and the third layer comprise a material with identical properties, and the spacer layer and the further spacer layer each have a supporting structure comprise a same material with identical material properties.
48. An apparatus according to claim 40, wherein the at least one flow unit provides overpressure and has a flow inlet connected to a gas reservoir, has an opening to an atmosphere surrounding the protective envelope for providing at least one of intake ambient air and a fluid connection to the at least one room region that is delimited by the protective envelope.
49. An apparatus according to claim 48, wherein the flow unit is a filter ventilator for producing air according to DIN EN ISO 14644-1:2016-06 from ambient air, and the fluidic connection between the flow outlet and the at least one room region or the spacer layer is a hollow duct comprising a material according to DIN EN ISO 14644-14:2017-01.
50. An apparatus according to claim 40, comprising: at least one sensor attached to each of the first layer, the second layer and the spacer layer which the at least one sensor is selected to sense at least one of: particulate contamination, molecular contamination or chemical contamination, temperature, pressure, humidity, flow, electrostatic sensor, and biocontaminants.
51. An apparatus according to claim 50, wherein the at least one sensor is connected to an evaluation, a control, or a regulator unit, which each generates at least one signal transmittable by at least one of a superordinate software and to at least one of the flow unit and to the evaluation, control and regulator unit.
52. An apparatus according to claim 40, wherein the at least the spacer layer has at least two areas with flow permeabilities in the longitudinal direction which differ from each other.
53. A use of the apparatus according claim 40, comprising: creating or maintaining the at least one room region to have control cleanliness either inside or outside of the room region separated by the protective envelope.
54. A use of the apparatus according claim 41, comprising: creating or maintaining the at least one room region to be control for cleanliness either inside or outside of the at least one room separated from the environment by the protective envelope.
55. A use of the apparatus according to claim 40, comprising making a facility by creating a room region free from viruses and cross-contamination to accommodate at least one of persons and objects which are subject to quarantine.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0058] In the following section, the invention will be described for exemplary purposes without limitation of the general inventive thought on the basis of embodiments with reference to the drawings. In the drawings:
[0059]
[0060]
[0061]
[0062]
[0063]
[0064]
[0065]
[0066]
[0067]
DETAILED DESCRIPTION OF THE INVENTION
[0068]
[0069] Alternatively to the construction of the second layer 2 with a cleanliness-compatible textile material, it is also possible to use alternative cleanliness-compatible material, in the form of a plastic film, for example.
[0070] The protective envelope S according to the invention is orientated with its flow-permeable first layer 1 closest to the production engineering unit 5 and is connected thereto preferably in spatially fixed manner, with the result that the protective envelope S separates a room region 6 containing unit 5 from the environment 7 surrounding the protective envelope S, corresponding to the cleanroom, which seals it in a manner preventing transfer of fluids and contamination. The attachment of the protective layer S to the production engineering unit 5 or subsections of the production engineering unit 5 is performed using fastening mechanisms that are known per se and are not part of this invention and are known to persons ordinarily skilled in the art.
[0071] Additionally, a flow unit 8, preferably in the form of a filter-ventilator unit, which is able to produce ultrapure air 11 from ambient air, feeds the surface air into the room region 6 through a fluid duct 9. The introduction of the ultrapure air 11 into the room region 6 results in a pressure difference relative to the interior of the spacer layer 3, with the result that a substance flow 10 is created from the room region 6 and into the spacer layer 3 through the first layer 1.
[0072] The quantity of the substance flow 10 passing through the first layer 1 is dependent on the pressure differential between room region 6 and the interior of the spacer layer 3 and the selection of the flow permeability of the first layer 1.
[0073] The substance flow 10 passing through the first layer 1 comprises on one hand the supplied ultrapure air, which is contaminated with particles or the like due to the operation of the production engineering unit inside the room region 6. In addition to particulate contaminants, the substance flow may also be polluted by chemical, biological or similar contaminants, all of which pass through the first layer 1 and flow out inside the spacer layer 3 for subsequent discharge of the substance flow 10′. Since the second layer 2 presents a barrier to the incoming substance flow 10 inside the spacer layer 3, the environment 7 corresponding to the cleanroom is neither polluted nor contaminated. The substance flow 10′ flowing along the longitudinal extension of the layer s can be discharged in unpressurised manner through a discharge line not shown in
[0074] In a further variant, a further flow unit 8′ is provided, which serves as a suction unit and is fluidically connected to the spacer layer 3. The substance flow 10′ is discharged from the spacer layer 3 in controlled manner with definable suction power via the flow unit 8′ which functions as a suction unit. The flow unit 8′, which is also embodied as a filter-ventilator unit, is advantageously able to convert the contaminated substance flow 10′ into ultrapure air 11 through corresponding filtration, and this is then returned to the environment 7, that is the cleanroom or the room region 6, via a discharge 12.
[0075] Besides the protective function of the protective envelope S according to the invention, the protective envelope S also extracts heat from or cool the production engineering unit 5 during operation thereof, since the ultrapure air fed into the room region 6 can also extract heat through the first the first layer 1 and by flowing along the spacer layer 3.
[0076] A practical alternative to feeding ultrapure air 11 into the room region 6, is the supply of a technical gas, for example H.sub.2O.sub.2, via the flow unit 8, in this case connected to a corresponding technical gas reservoir, not shown here.
[0077]
[0078] Similarly to the representation of
[0079] To avoid repetitions, reference is herewith made to the preceding notes regarding the operating principle of flow units 8 and 8′ in terms of producing and feeding ultrapure air 11 into the room region 6 and the extraction of the contaminated substance flow 10′ by controlled underpressure with the aid of flow unit 8′ and optional treatment to obtain ultrapure air 11.
[0080] A further flow unit 8″ is fluidically connected to the further spacer layer 15, which is delimited by the third and fourth layers 13, 14, and is operated as an underpressure source and is able to extract a substance flow 10″ by suction and optionally convert it into ultrapure air 11, which can then be fed to the environment 7 via a discharge 12′. Air L is sucked out of the environment 7 through the fourth layer 14 and into the further spacer layer 15 with the flow unit 8″ functioning as the underpressure source. In this way, the environment 7, which corresponds to the cleanroom, undergoes an additional purification effect.
[0081]
[0082] The sensors 16 which are attached to the protective envelope S can be used to capture more than contamination parameters to also detect and monitor the status of the protective envelope S, the cleanroom quality of the environment 7 as well as the operating state of the production engineering unit 5. The sensor signals generated by the individual sensors 16 are forwarded to an evaluation and control unit 17, which generates at least a signal 18 usable for further functions: Firstly, the signal 18 is used for controlled operation of the individual flow units 8, 8′, 8″. The signal 18 may also control the production engineering unit 5. The signal 18 may also be used by AI software or the like for analyzing and forecasting the protection function and reliability of the protective envelope in operation.
[0083]
[0084] In order to operate the protective envelope S, three flow units 8, 8′, 8″ are provided. The flow unit 8 feeds ultrapure air 11 or a technical gas, preferably H.sub.2O.sub.2, into the room region 6, thereby creating an overpressure with respect to the pressure conditions prevailing in the environment 7, which correspond to atmospheric pressure. The flow unit 8′ is fluidically connected to the spacer layer 3 and suctions a contaminated substance flow 10′ out. In the same way, the flow unit 8″ which functions as a suction unit, is able to extract a substance flow 10″ from the further spacer layer 15.
[0085] The protective envelope arrangement S illustrated in
[0086] The protective envelope S with the sensors 16 integrated therein is preferably at least one of fitted, draped and unfolded over the unit 5, for example, a robot, so that a flowing enclosure is created around the unit 5.
[0087] The apparatus according to the invention affords the following advantages in respect of cleanliness and hygiene (low level of own emissions by system elements, interior region monitored for particulates, chemical and microbiological contaminants). The flow units, in the form of a filter-ventilator unit, generate a defined volume flow in pure air qualities of air purity classes 1 to 9, as are defined in ISO 14644-1.
[0088] Variations of the defined flow management system for ensuring a defined overpressure/underpressure:
[0089] Realization by at least one cleanliness-compatible textile or multilayer covering which is constructed from at least one layer combination, that is first and second layers with the spacer layer located between them. Varying degrees of permeability of the individual layers may be chosen, depending on the cleanliness specifications that are to be satisfied.
[0090] Cleanliness conditions are provided (installation, commissioning) in a brief time window (rapid set up and teardown).
Low intrinsic rigidity, so that the motion sequence is only minimally hindered. [0091] The apparatus for creating clean conditions is lightweight. [0092] Use in areas monitored for cleanliness standards. [0093] The apparatus satisfies the cleanliness/hygiene requirements as described in the pertinent regulation families, that is, ISO 14644, VDI 2083, cGMP classes A to D (defines limits for the number of airborne germs). [0094] The apparatus fulfils the capability of mechanical cleanability of the components. [0095] The apparatus allows layer-specific charging with technical gases, so that protection can be provided not only for the environment but also for the product and the automation unit. [0096] Low adhesion forces between the textile or multilayer covering and automation components. [0097] The flow permeability is adjustable, so that individual zones can be defined and supplied with increased volumes of ultrapure air separately, depending the degree of soiling, for example. The same applies for other application areas, and gases, that is for dissipating thermal loads or creating a protective gas atmosphere. [0098] The measurement processes enable a wide range of analyze, relating to the operating history, the status of the automation unit as well as the status of the system itself, thereby assuring both good reliability and system stability. [0099] Construction of the protective envelope material in product-specific version (with adjustable/compilable permeability): from completely closed (airtight) through semi-permeable to completely open in terms of fluid flows.
[0100] The protective envelope material, that is the material of the first to fourth layers may also possess the following additional properties: [0101] envelope material of the textile/multilayer covering with good electrostatic dissipation properties. [0102] low-particulate envelope material. [0103] low outgassing envelope material. [0104] microbicidal and sterilisable envelope material. [0105] particle absorbing or filtering envelope material. [0106] no additional support construction. [0107] complete aspiration of the production plant without additional hoses; semi-integral suction. [0108] semi-integral suction inner side of the protective envelope (facing towards the plant/automation component) and outer side of the protective envelope are sucked into the interior of the spacer fabric together. [0109] textile/multilayer covering (spacer material) functions as integral suction [0110] internal air-permeable construction of the axis of rotation for underpressure suction. [0111] close-fitting textile/multilayer covering, low bulk with minimal movement restriction. [0112] electrically conductive. [0113] fire-retardant.
[0114] The materials listed above are suitable for use in a protective envelope and promote rapid erection of a temporary or permanent installation for creating a virus-free and cross-contamination free room region for accommodating at least one of persons and objects subject to quarantine.
[0115] In the exemplary embodiment shown, the protective envelope S that delimits the room region 6 having a first layer 1, closest to the room region 6, a second layer 2 and a spacer layer 3 which keeps the two layers 1, 2 spaced from each other.
[0116] For the purpose of mechanical separation of the first and second layers 1, 2, the spacer layer 3 has an inner supporting structure 4, preferably in the form of a spacer fabric, which allows practically unhindered flow permeability in the longitudinal extension direction s of the layer.
[0117] Ultrapure air 11, or at least a virus-free and biocontamination-free, sterile air flow 11′, is fed into the spacer layer 3. The continuous sterile feed flow into the spacer layer 3 causes the formation of an internal layer pressure p2 as a function of the selected flow permeabilities in the first and second layers 1, 2 and the continuously flowing air stream components resulting therefrom, which pass through the first layer 1 into the room region 6, see air stream component 19, and through the second layer 2 into the environment U, as air stream component 20. The flow is preferably delivered in such manner that for the layer internal pressure p2, for the room internal pressure p1 created in the room region 6, and for the ambient pressure p3, which is equivalent to the atmospheric ambient pressure which is considered usual, the following correlation is true: p2>p1 and p2>p3, and preferably p1>p3.
[0118] In the embodiment according to
[0122] In order to guarantee that the environment U does not become contaminated by the quarantine protection apparatus, the protective envelope S has a defined outlet area 23 which is fluidically connected to a discharge 24 that leads to the flow unit 21. In the flow unit 21, the exhaust air exiting the room region 6 is sterilized, and after sterilization is returned to the feed line 22 in a closed circuit, for example, or discharged into the environment U. Depending on the conditions on-site, in this way it is possible to operate the quarantine protection apparatus in complete isolation from the environment U with a “closed-loop air flow”, or after complete sterilization the ambient air can be used, in which case, after the room region 6 has been uniformly filled with sterile air the contaminated air may be discharged into the environment U following corresponding sterilization.
[0123] Because it entails the use of so few materials and components, the protection apparatus according to the invention can be set up and put into operation within a few minutes.
[0124] The flow-permeable textile material used for making the protective envelope designed as a multilayer system may be constructed as a flexible, elastic or even a rigid layer, for example in in the form of woven layers, film layers or plate material with defined degrees of perforation, which means that, when not filled with air even large numbers of the protection apparatuses can be stored and stockpiled and do not take up an inordinate amount of space. The flow-permeable material preferably satisfies the same cleanliness requirements to which the textile material used in the preceding embodiments in
[0125] In order to create the pressure conditions described, that is p1<p3<p2, at least one or also several flow units may be used, working with overpressure or underpressure to either extract contaminated air in controlled manner out of the room region 6 and collect it, or conversely to isolate the contaminants from the external region.
[0126]
[0127] For the purpose of sterilizing the supply air from the surrounding atmosphere or the contaminated air extracted from room region 6, besides known sterilization techniques such as gamma sterilization, H2O2 sterilization, HEPA filters or heat input using heaters, sterilization by UVC irradiation in the far UVC wavelength range at about 222 nm is particularly effective. The use of an UVC irradiation unit may be applied in many situations for the regions and components of the quarantine system according to the invention, for example as integral radiation components within a filter-ventilator unit, on the protective envelope inside the room region, on or inside the protective envelope, for example in the form of a multiplicity of LED floodlamps. UVC irradiation units of such kind may be arranged particularly at the flow outlet area or along the feed and discharge lines.
[0128]
[0129] In order to optimize the interior quarantine area, additions of technical gases 31, that is pure oxygen, may be introduced in metered quantities.
[0130] The quarantine system illustrated in
[0131] The quarantine suite may also supplemented and organized with accesses, service hatches, connecting corridors etc. with the doors, windows, locks, connections, ducts etc. known from the related art.
[0132] Consequently, the following advantages may be ascribed to the described quarantine system according to the invention: [0133] The system can be erected very quickly, within a few minutes, in any location in the world, and is ready for operation immediately upon commissioning. [0134] It offers maximum protection from cross-contaminations and any potential viral transfer which is to be avoided. [0135] The system is sterilisable and washable. [0136] After sterilisation or washing, the system can be packed in convenient, sterile packages, for example by welding in to gastight/sterile foil pouches, so that it is ready for use immediately after unpacking, and therefore can be stored in sterile conditions for long periods and is easy to keep sterile when transporting. [0137] The system can be manufactured in advance very inexpensively. [0138] Its very small package dimensions (collapsible) mean that larger storage spaces do not have to be set aside, storage can take up very little room. [0139] Maximum protection for operating and service staff and doctors. [0140] Maximum protection for quarantine patients from re-infection. [0141] Inexpensive operation of the cleanliness-compatible quarantine system, with no complex gas, power or chemical supplies. [0142] The media needed to care for the patient (power cables, data cables, hoses, etc.) can be introduced very quickly and simply through integrated, closable openings. [0143] No complex disposal of materials contaminated with virus or biocontaminants is necessary with inexpensive, simple disposal as needed. [0144] Reuse possible. [0145] Low procurement costs. [0146] Negligible operating costs (only electricity for ventilator unit and electricity for running the UVC sterilisation lamps) are necessary. [0147] Operationally reliably application is achieved.
[0148] Preferred areas of use for the protection apparatus according to the solution are summarized as follows:
[0149] Cleanliness-compatible/hygiene (free from viruses/bacteria and other microorganisms) controlled areas such as are needed in the following application fields:
[0150] Aerospace, optics, life sciences (biochemistry, bioinformatics, biology, biomedicine, biophysics, bio- and genetic engineering, vaccination development, medicine (hospital, temporary hospital, hospital beds, intensive care units, operating theatres, doctors' surgeries, wards in health offices, airports, railway stations and conference halls, field research), medical engineering, pharmaceuticals and pharmacology, environmental management and environmental engineering), chemistry.
LIST OF REFERENCE SIGNS
[0151] 1 First layer [0152] 2 Second layer [0153] 3 Spacer layer [0154] 4 Supporting structure/Spacer fabric [0155] 5 Production engineering unit [0156] 6 Room region [0157] 7 Environment, cleanroom [0158] 8, 8′, 8″ Flow unit [0159] 9 Fluid duct [0160] 10, 10′, 10″ substance flow [0161] 11 Ultrapure air [0162] 11′ Virus-fee and biocontamination free air flow [0163] 12, 12′ Discharge [0164] 13 Third layer [0165] 14 Fourth layer [0166] 15 Further spacer layer [0167] 16 Sensor [0168] 17 Evaluation and Control unit [0169] 18 Signal [0170] 19 Air stream component flowing into the room region through the first layer [0171] 20 Air stream component flowing into the environment through the second layer [0172] 21 Flow unit, preferably filter-ventilator unit [0173] 22 Sterile feed line [0174] 23 Outlet area [0175] 24 Discharge [0176] 25 Second flow unit, designed as filter-ventilator unit [0177] 26 Floor area [0178] 27 Persons subject to quarantine [0179] 28 Ventilator Unit [0180] 29, 29′ UVC irradiation unit [0181] 30 Contaminated room air [0182] 31 Feed for technical gases [0183] 32 Access airlock [0184] S Protective envelope [0185] L Air [0186] U Environment [0187] Q Quarantine module