Zonke izimboni › Ilabhoratri — umoya wegumbi elihlanzekile nobuqotho bamasampula 🔬 Ilabhoratri — umoya wegumbi elihlanzekile nobuqotho bamasampula Imodeli ephilayo Wena ungumphathi welabhoratri. Igumbi le-ISO 7 le-aseptic elingu-75 m³ lisetshenziswa yiyunithi yokuphatha umoya ngezihlungi ze-HEPA; abantu bakhipha izinhlayiya, izicabha zivumela umoya wekholidoli ungene, futhi i-fume hood idonsa ukukhipha okungashintshi okungathatha ingcindezi eyeqile yegumbi. Phansi ehholo ifriza yokushisa okuphansi kakhulu igcina amaraki amane amasampula ku-−80 °C. Njalo ngemizuzu emihlanu imodeli ilinganisa izinhlayiya egumbini, ukugeleza komoya ngezikhala zesicabha nokushisa okungena efrizeni. Ukulingisa kwemfundo kuphela — hhayi iseluleko se-GMP, sokulandela imithetho noma sokwelapha.
Okuzofunda Kungani igumbi elixutshwe kahle lizinza ku-C = G/Q futhi lululama njenge-e^(−N·t): abantu bamisa izinga, ukushintsha komoya kumisa isivinini. Ukuthi i-pressure cascade isebenza kanjani ngempela: umehluko phakathi kokuhlinzeka nokukhipha, umthetho wesikwele ngezikhala zesicabha, nokuthi izicabha ezivulekile nokukhipha kwe-hood okungashintshi kukwenza kanjani. Ukuthi ifriza engu-−80 °C ehlulekile ifudumala ngokushesha kangakanani (umthetho kaNewton), nokuthi kungani amasampula ephulwa ngokwenza lapho kuhlaba umkhosi, hhayi emkhawulweni. Isilingisi esiphilayo sidinga i-JavaScript. Yonke into engezansi — imodeli, amafomula ayo nemithombo — iyafundeka ngaphandle kwayo.
Isilingisi
Ikilasi legumbi (ISO 14644-1, ≥0.5 µm) 6.86 · Izinhlayiya ≥0.5 µm 256 k/m³ · Umehluko wengcindezi nekholidoli (okumaphakathi esikhathini) 12.4 Pa · Ukushintsha komoya okuhlinzekiwe 20 · Abantu egumbini 3 · Izinga lokushisa lekhabhinethi yefriza -80.0 °C · Iraki yesampula efudumele kakhulu -80.0 °C · Isampula ngaphezu kuka-−60 °C (imizuzu-amaraki) 0 min Igumbi le-aseptic ISO 6.9 Ukuhlinzeka 20/h · 0.45 kW ○ ○ ○ I-hood ⇡ → 12.4 Pa Ikholidoli ⇄ 0 Ifriza engu-−80 °C ❄ -80.0 °C 1 ✓ -80° 2 ✓ -80° 3 ✓ -80° 4 ✓ -80° Ifriza yesipele Ibhokisi leqhwa elomile · 20.0 kg Izinhlayiya ≥0.5 µm 256 k/m³ Umsebenzi owenziwe uma uqhathaniswa nohlelo 0% Iraki yesampula efudumele kakhulu -80.0 °C Isampula ngaphezu kuka-−60 °C (imizuzu- amaraki) 0 min ✓ Iraki ku-−70 °C noma ngaphansi! Iraki phakathi kuka-−70 no-−60 °C⚠ Iraki engaphezu kuka-−60 °C (ukweqa)◍ Umuntu ogqoke i-coverall yegumbi elihlanzekile○ Umuntu ogqoke ijazi lelabhoratri• Izinhlayiya zasemoyeni (isikali selogarithimu)❄ I-compressor iyasebenza / i-hood iyasetshenziswa✕ I-compressor iyimile / i-hood ekulindeniIzilawuli Izingubo Ijazi lelabhoratri
Ijazi lelabhoratri I-coverall yegumbi elihlanzekile, i-hood, imaski Ama-coverall egumbi elihlanzekile anciphisa cishe uhhafu wezinhlayiya ezingu-≥0.5 µm umuntu azikhipha uma kuqhathaniswa nejazi lelabhoratri phezu kwezingubo zangaphakathi. Ukushintsha kuthatha cishe imizuzu engu-10.
Hambisa amaraki efrizeni yesipele Ihambisa amaraki ezikhaleni ezikhululekile zefriza yesipele ngemva kwesikhathi sokubiza abasebenzi (isikhathi eside ebusuku). Lezi zikhala ziyisigcinelo sesimo esiphuthumayo sesakhiwo, zikhululwa kuphela efrizeni enephutha noma ekhalisa i-alamu — isicelo ngenkathi isabambe u-−80 °C siyenqatshwa. Iraki ngalinye lichitha cishe imizuzu emibili emoyeni wegumbi endleleni.
Paka amaraki eqhweni elomile Ipaka amaraki asele efrizeni emabhokisini avikelwe ukushisa ngeqhwa elomile (u-10 kg ngeraki ngalinye, ngokusho kwesitoko). Ibhokisi ligcina u-−78.5 °C inqobo nje uma leli qhwa lisekhona.
Izikhombisi Ikilasi legumbi (ISO 14644-1, ≥0.5 µm)
6.86
isixwayiso
Umehluko wengcindezi nekholidoli (okumaphakathi esikhathini)
12.4 Pa
kuvamile
Iraki yesampula efudumele kakhulu
-80.0 °C
kuvamile
Isampula ngaphezu kuka-−60 °C (imizuzu-amaraki)
0 min
kuvamile
Izinhlayiya ≥0.5 µm 256 k/m³ Ukushintsha komoya okuhlinzekiwe 20 1/h Amandla efeni yokuhlinzeka 0.45 kW Abantu egumbini 3 Umsebenzi owenziwe uma uqhathaniswa nohlelo 0 % · kubucayi Umehluko wengcindezi, izicabha zivaliwe 12.4 Pa Ukuvulwa kwezicabha kuleli phuzu 0 Izinga lokushisa lekhabhinethi yefriza -80.0 °C Iqhwa elomile elisele 20.0 kg Amaraki asefrizeni 4
Isitayela Isilinganiso seshadi Ikilasi legumbi (ISO 14644-1, ≥0.5 µm) Umehluko wengcindezi nekholidoli (okumaphakathi esikhathini) Iraki yesampula efudumele kakhulu Isampula ngaphezu kuka-−60 °C (imizuzu-amaraki) Izinhlayiya ≥0.5 µm Ukushintsha komoya okuhlinzekiwe Amandla efeni yokuhlinzeka Abantu egumbini Umsebenzi owenziwe uma uqhathaniswa nohlelo Umehluko wengcindezi, izicabha zivaliwe Ukuvulwa kwezicabha kuleli phuzu Izinga lokushisa lekhabhinethi yefriza Iqhwa elomile elisele Amaraki asefrizeni Ikilasi legumbi (ISO 14644-1, ≥0.5 µm): — 9.00 4.00 Izimo eziphuthumayo Izinga 1 · Ukubuyela ekilasini ngaphambi kwesinyathelo se-aseptic Ngu-08:00. Ebusuku igumbi lisebenze ku-setback yokonga amandla ngokushintsha komoya okungu-5 ngehora kanye ne-hood ekulindeni, futhi inkontileka egqoke izingubo zasemgwaqweni isanda kuqeda umsebenzi ngaphakathi: isibali sifunda cishe izinhlayiya ezingu-3 million nge-m³. Abantu abayisithupha begqoke amajazi elabhoratri bayalungisa. Ngo-08:30 iqembu labantu abathathu liqala isinyathelo se-aseptic esidinga igumbi ku-ISO 7 noma kangcono kuze kube ngu-10:00. Gcina iqembu egumbini futhi inkokhelo yefeni ibe nengqondo.
Igumbi ku-ISO 7 noma kangcono phakathi nesinyathelo sonke Okungenani abantu abathathu egumbini phakathi nesinyathelo Amandla efeni yokuhlinzeka amaphakathi ≤ 0.6 kW Izinga 2 · Ukwehluleka kwefriza ebusuku Ngu-21:00 futhi wena useshifini yokubizwa. Ifriza engu-−80 °C inamaraki amane amasampula angenakushintshwa. Cishe ngo-22:00 i-compressor yayo iyama; uchwepheshe wesevisi angafika kuphela ngo-07:30. Ifriza yesipele inendawo yamaraki amabili — isigcinelo sesimo esiphuthumayo sesakhiwo, esikhululwa kuphela efrizeni enephutha noma ekhalisa i-alamu — futhi kukhona u-20 kg weqhwa elomile endaweni, elanele amabhokisi amabili. Noma yini oyicelayo, kufanele kuqale kufike othile: cishe imizuzu engu-30 ebusuku. Unogada ozungezayo ubheka ifriza ngezikhathi ezithile. I-SOP yelabhoratri ithi akukho sampula okufanele idlule u-−60 °C, futhi iqembu licela isikhala sokuphepha: amaraki akufanele neze afudumale ngaphezu kuka-−68 °C.
Akukho raki engaphezu kuka-−60 °C ubusuku bonke Akukho mizuzu yokweqa ekugcineni Amaraki angalokothi afudumale ngaphezu kuka-−68 °C (isikhala sokuphepha) Izinga 3 · Isiphatha-moya esiphuthumayo, igumbi eligcwele Isifundo sokuqeqeshwa esiyihora elingu-4 esisebenzayo sinabantu abayisikhombisa begqoke amajazi elabhoratri egumbini kanye nomfudlana ongaguquki wezivakashi ngesicabha sekholidoli. Imizuzu eyishumi ngemva kokuqala, ifeni yokuhlinzeka iqala ukwehluleka: ingahlinzeka kuphela ama-40 % omthamo wayo (ukushintsha komoya okungu-16 ngehora) kuze kulungiswe kusasa. I-fume hood iyasetshenziswa futhi idonsa u-1100 m³/h wokukhipha okungashintshi. Gcina igumbi ku-ISO 7, ugcine okungenani u-10 Pa ngaphezu kwekholidoli, futhi uqedele umsebenzi ohleliwe.
Igumbi ku-ISO 7 noma kangcono Umehluko wengcindezi omaphakathi ≥ 10 Pa Umsebenzi ohleliwe uqediwe Isisekelo — imodeli engemuva kwezinombolo Wonke ubudlelwano isilingisi esibusebenzisayo, nomthombo wabo. Izinto ezihlala zingashintshi ezimakwe njengokuthathelwa yizilinganiso zesibonelo.
Ezinye izinto ezingaguquki zokusebenza ezisetshenziswa yimodeli. room 75 m³, AHU ≤ 40 air changes/h × health · HEPA 99.95 %, 20 % outdoor air at 35·10⁶ /m³ · corridor 2·10⁶ /m³ · fixed exhaust 1100 m³/h (hood in use) / 500 m³/h (standby) · gowning change 10 min · 1 door trip per person-hour · work × 0.8 with the hood in standby, × 0.95 with airlock discipline · freezer UA 2 W/K, compressor 600 W, alarm −70 °C, SOP limit −60 °C · 4 racks of 15 kJ/K · backup freezer −80 °C, its free slots released only for a freezer in fault or alarm (emergency reserve) · 10 kg dry ice per rack, chest UA 0.25 W/KIsimo esicatshangelwayo: usayizi wegumbi, umthamo we-AHU, ukukhipha okungashintshi, indawo yokuvuza, izikhathi zezicabha nemithamo eshintshwayo, amandla efeni, ukuvikelwa kokushisa kwefriza nosayizi we-compressor, ukushisa komthamo weraki, ukuchayeka ekuphatheni, ukukhululwa kwezikhala zefriza yesipele ezimeni eziphuthumayo kuphela nomkhawulo we-SOP ongu-−60 °C kuyizinombolo zesibonelo zelabhoratri ejwayelekile; imithetho yefiziksi namazinga okusabalala ashicilelwe njengoba kucashunwe. Ukungahleliwe: i-generator ye-mulberry32 enembewu; ukusabalalisa okusetshenzisiwe — uniform, exponential (inverse CDF), normal (Box–Muller), Poisson (Knuth). Imbewu iyabonisa futhi ingabelwana.
Imithombo ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration (Cn = 10^N·(0.1/D)^2.08) — ISO, 2015ISO 14644-3:2019 Cleanrooms and associated controlled environments — Part 3: Test methods (recovery test, 100:1 recovery time) — ISO, 2019 EudraLex Vol. 4, Annex 1: Manufacture of Sterile Medicinal Products (C(2022) 5938) — §4.13 airlock entry and exit doors not opened simultaneously (interlock for grade A/B, visual/audible warning for C/D), §4.14 adjacent rooms of different grades: air pressure difference of a minimum of 10 Pascals (guidance value), §4.29 iii and Table 5 Note 1: "clean up" period, guidance value of less than 20 minutes — European Commission, 2022W. Whyte, M. Hejab — Particle and microbial airborne dispersion from people, European Journal of Parenteral & Pharmaceutical Sciences 12(2):39–46 (≥0.5 µm: 2.13·10⁶/min indoor clothing, 1.02·10⁶/min cleanroom garments) — Pharmaceutical and Healthcare Sciences Society, 2007W. Whyte — Cleanroom Technology: Fundamentals of Design, Testing and Operation, 2nd ed. (well-mixed dilution C = G/Q, decay and recovery, pressure cascades, door openings) — Wiley, 2010 ASHRAE Handbook — Fundamentals, ch. 16 Ventilation and Infiltration (flow through openings Q = C_d·A·√(2ΔP/ρ)) — ASHRAE, 2021 EN 1822-1:2019 High efficiency air filters (EPA, HEPA and ULPA) — Part 1: Classification (H13 ≥ 99.95 % at MPPS) — CEN, 2019 Fan affinity laws: flow ∝ speed, pressure ∝ speed², power ∝ speed³ — U.S. DOE — Improving Fan System Performance: A Sourcebook for IndustryF. P. Incropera, D. P. DeWitt et al. — Fundamentals of Heat and Mass Transfer, 7th ed., §5.1–5.3 lumped capacitance (Newton cooling, τ = ρVc/hA) — Wiley, 2011 NIST Chemistry WebBook — Carbon dioxide, phase change data (ΔsubH = 25.2 kJ/mol at 195 K, Giauque & Egan 1937 → ≈ 573 kJ/kg; sublimation at 194.7 K = −78.5 °C at 1 atm) — NISTISBER Best Practices: Recommendations for Repositories, 5th ed. (storage equipment monitoring and alarms, backup storage capacity, emergency plans) — International Society for Biological and Environmental Repositories, 2023 Obani abenza lokhu ukuze baziphilise Imodeli yemfundo — hhayi yezinqumo zokusebenza. Izindawo zangempela zilinganisa yonke into ehlala ingashintshi kumishini nedatha yazo.