DK2464913T3 - Modulært, selvstændigt, mobilt renrum - Google Patents
Modulært, selvstændigt, mobilt renrum Download PDFInfo
- Publication number
- DK2464913T3 DK2464913T3 DK10810440.7T DK10810440T DK2464913T3 DK 2464913 T3 DK2464913 T3 DK 2464913T3 DK 10810440 T DK10810440 T DK 10810440T DK 2464913 T3 DK2464913 T3 DK 2464913T3
- Authority
- DK
- Denmark
- Prior art keywords
- clean room
- air
- unit
- water
- room
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L1/00—Enclosures; Chambers
- B01L1/04—Dust-free rooms or enclosures
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F11/00—Control or safety arrangements
- F24F11/30—Control or safety arrangements for purposes related to the operation of the system, e.g. for safety or monitoring
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
- F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
- F24F3/16—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by purification, e.g. by filtering; by sterilisation; by ozonisation
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F3/00—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems
- F24F3/12—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling
- F24F3/16—Air-conditioning systems in which conditioned primary air is supplied from one or more central stations to distributing units in the rooms or spaces where it may receive secondary treatment; Apparatus specially designed for such systems characterised by the treatment of the air otherwise than by heating and cooling by purification, e.g. by filtering; by sterilisation; by ozonisation
- F24F3/167—Clean rooms, i.e. enclosed spaces in which a uniform flow of filtered air is distributed
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F8/00—Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F2110/00—Control inputs relating to air properties
- F24F2110/10—Temperature
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F2110/00—Control inputs relating to air properties
- F24F2110/20—Humidity
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F2110/00—Control inputs relating to air properties
- F24F2110/40—Pressure, e.g. wind pressure
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F24—HEATING; RANGES; VENTILATING
- F24F—AIR-CONDITIONING; AIR-HUMIDIFICATION; VENTILATION; USE OF AIR CURRENTS FOR SCREENING
- F24F2110/00—Control inputs relating to air properties
- F24F2110/50—Air quality properties
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/20—Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Landscapes
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- General Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Combustion & Propulsion (AREA)
- Mechanical Engineering (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Wood Science & Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Clinical Laboratory Science (AREA)
- Biotechnology (AREA)
- Sustainable Development (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Ventilation (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Air Conditioning Control Device (AREA)
Claims (18)
1. Enhedsstruktur omfattende: mindst et luftstyret, tætneligt, steriliserbart renrum, og et mekaniksystemrum tilgrænsende til renrummet omfattende: mindst to luftningsenheder i et forsyningsrum tilgrænsende renrummet der tilvejebringer redundant luft til renrummet med mindst luftrenhed klasse 100.000, udluftningsenhederne forbundet til én eller flere tilførselskanaler til renrummet, og en udluftningskanal i forbindelse med renrummet og luft som udledes fra luftningsenheden, hvor en trykgradient er dannet mellem renrummet og det eksterne af strukturen; hvilken struktur er kendetegnet ved at den yderligere omfatter mindst to strømforsyninger der tilvejebringer strøm til elektriske udgange i renrummet fra to kilder, hvor de mindst to strømforsyninger kan forbindes til én eller flere eksterne elektriske strømkilder.
2. Strukturen ifølge krav 1, yderligere omfattende et enhedsinformationsteknologisystem der tilsluttes til et intranet, et extranet eller begge, hvor systemet tilsluttes til og styrer én eller flere sensorer, ét eller flere eksterne styringselementer tilsluttet til én eller flere sensorer der overvåger, temperatur, fugtighed, lufttryk, udstyrstatus, sikkerhed, brandbeskyttelse, kemisk eller biologisk forurening, kabelforbundet internettilslutning eller trådløs tilslutning.
3. Strukturen ifølge krav 1 eller 2, yderligere omfattende universal-tilslutninger omfattende mindst en af en elektrisk, vand, spildevand, gas, HVAC, vand- eller luftfiltreringsindgange/udgange.
4. Strukturen ifølge krav 1 til 3, hvor luftningsenheden og strømforsyningerne har øjeblikkelig fejl-over drift af renrummet uden tab af luft eller strøm til renrummet.
5. Strukturen ifølge krav 1 til 4, hvor strukturen omfatter vand-, gas-, afvandingsvand-, eller spildevandsystemer og disse systemer er reparerbare i mekaniksystemrummet uden tab af service til renrummet.
6. Strukturen ifølge krav 1 til 5, hvor strukturen kan flyttes uden afbrydelse fra forsyningerne af elektricitet, vand, afvandingsvand, spildevand, gas, koldt vand eller varmt vand forbundet til strukturen.
7. Strukturen ifølge krav 1 til 6, hvor strukturen omfatter mindst ét eller flere forstærkede gulve, bestående af I-bjælker under gulvet, vibrationsdæmpere, og andre forstærkningselementer til at støtte ét eller flere specifikke udstyr; eller én eller flere tilførselskanaler omfatter én eller flere dæmpere indrettet til at variere det indre tryk i ét eller flere områder inde i renrummet og derved danne en trykgradient mellem det indre tryk og atmosfærisk tryk udenfor strukturen.
8. Strukturen ifølge krav 7, hvor det indre tryk kan veksles til at være større end, mindre end eller lig med atmosfærisk tryk.
9. Strukturen ifølge krav 1 til 6, hvor renrummet er forsynet med mindst luftrenhed klasse 10.000, 1000, 100 eller 10.
10. Strukturen ifølge et hvilket som helst af kravene 1 til 9, hvor strukturen yderligere omfatter en tætnet omhylning efterfulgt validering for cGMP fremstilling.
11. Biosikkerhedsenhed omfattende: mindst et luftstyret, tætneligt, steriliserbart renrum, og et mekaniksystemrum tilgrænsende til renrummet omfattende to eller flere redundante systemer, idet de redundante systemer omfatter: mindst to luftningsenheder i et forsyningsrum tilgrænsende renrummet der tilvejebringer redundant luft til renrummet med mindst luftrenhed klasse 100.000, luftningsenhederne forbundet til én eller flere tilførselskanaler til renrummet, og en udluftningskanal i forbindelse med renrummet og luftningsenheden, hvor en trykgradient er dannet mellem renrummet og det ydre af enheden; enheden kendetegnet ved at den yderligere omfatter mindst to strømforsyninger der tilvejebringer redundant strøm til elektriske udgange i renrummet, hvor de mindst to strømforsyninger kan tilsluttes til én eller flere eksterne strømkilder, fortrinsvis hvor enheden er forvalideret eller valideret i overensstemmelse med kravene afen relevant regulatorisk forvaltning.
12. Fremgangsmåde til fremstilling af en forvaliderbar enhed omfattende at: bygge mindst et luftstyret, tætneligt, steriliserbart renrum; og forbinde til bygningen et mekaniksystemrum tilgrænsende til renrummet omfattende: mindst to luftningsenheder i et forsyningsrum tilgrænsende renrummet der tilvejebringer redundant luft til renrummet med mindst luftrenhed klasse 100.000, luftningsenhederne forbundet til én eller flere tilførselskanaler til renrummet, og en udluftningskanal i forbindelse med renrummet og luftningsenheden, hvor en trykgradient er dannet mellem renrummet og det ydre af enheden; og mindst to strømforsyninger der tilvejebringer strøm til elektriske udgange i renrummet fra to kilder, hvor de mindst to strømforsyninger kan forbindes til én eller flere eksterne elektriske strømkilder.
13. Fremgangsmåden ifølge krav 12, yderligere omfattende trinnet at forbinde et enheds-informationsteknologisystem der tilsluttes til et intranet, et extranet eller begge, hvor systemet tilsluttes til og styrer én eller flere sensorer.
14. Fremgangsmåden ifølge krav 12 eller 13, yderligere omfattende trinnet at forbinde ét eller flere eksterne styringselementer tilsluttet til én eller flere sensorer der overvåger, temperatur, fugtighed, lufttryk, udstyrsstatus, sikkerhed, kemisk eller biologisk forurening, kabelforbundet internettilslutning eller trådløs tilslutning til enheden.
15. Fremgangsmåden ifølge krav 12 eller 14, yderligere omfattende trinnet at tilpasse luftningsenhederne og strømtilførslerne til at have øjeblikkelig udfaldssikring under drift af renrummet uden tab af luft eller strøm til renrummet.
16. Fremgangsmåden ifølge krav 12 eller 15, yderligere omfattende trinnet til tilføre ét eller flere udfaldssikringssystemer at forsyne service til renrummet valgt fra mindst én af vand-, gas-, afvandingsvand-, koldtvand- eller spildevandsystemer.
17. Fremgangsmåden ifølge krav 12 eller 16, yderligere omfattende trinnet at forbinde fleksibel forbindelsesklemme der tillader enheden at kunne flyttes uden afbrydelse fra forsyning af elektricitet, vand, afvandingsvand, spildevand, gas, koldt vand eller varmt vand forbundet til enheden.
18. Fremgangsmåden ifølge krav 12 eller 17, yderligere omfattende trinnet at forsyne renrummet med mindst luftrenhed klasse 10.000, 1000, 100 eller 10 der kan serviceres uden at komme ind i renrummet.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US23430209P | 2009-08-16 | 2009-08-16 | |
PCT/US2010/045599 WO2011022325A2 (en) | 2009-08-16 | 2010-08-16 | Modular, self-contained, mobile clean room |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2464913T3 true DK2464913T3 (da) | 2018-05-22 |
Family
ID=43607543
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10810440.7T DK2464913T3 (da) | 2009-08-16 | 2010-08-16 | Modulært, selvstændigt, mobilt renrum |
Country Status (18)
Country | Link |
---|---|
US (2) | US9518748B2 (da) |
EP (1) | EP2464913B1 (da) |
JP (2) | JP5879264B2 (da) |
KR (2) | KR20120054634A (da) |
CN (2) | CN102575858B (da) |
BR (1) | BR112012003549B1 (da) |
CA (1) | CA2772234C (da) |
DK (1) | DK2464913T3 (da) |
ES (1) | ES2665972T3 (da) |
HK (1) | HK1173769A1 (da) |
IL (2) | IL218086A (da) |
IN (1) | IN2012DN01645A (da) |
MX (1) | MX345159B (da) |
MY (1) | MY161931A (da) |
NZ (1) | NZ598219A (da) |
SG (1) | SG178448A1 (da) |
WO (1) | WO2011022325A2 (da) |
ZA (1) | ZA201201606B (da) |
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KR20170040255A (ko) * | 2014-07-11 | 2017-04-12 | 지-콘 메뉴팩츄어링 인코포레이티드 | 유틸리티를 청정실, 격리 또는 봉쇄 큐비클, 포드 또는 모듈에 공급하는 모듈형 부품 |
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