Jilayaasha WIA SOOM

Shaybaarka — hawada qolka nadiifka iyo daacadnimada muunadaha Qaabka tooska ah

Waxaad tahay maamulaha shaybaarka. Qol aseptic ISO 7 ah oo 75 m³ ah waxaa hawo ka siiya cutub maareyn hawo oo marsiiya shaandhooyinka HEPA; dadku waxay daayaan walxo, albaabadu waxay soo gelinayaan hawada wadada dhex-marta, hood-ka qiiquna wuxuu soo jiidaa hawo-saar go'an oo qaadi kara cadaadiska dheeraadka ah ee qolka. Wadada dhex-marta hoosteeda qaboojiye aad u hooseeya wuxuu hayaa afar rack oo muunado ah −80 °C. Shan daqiiqo kasta moodelku wuxuu isu dheelitiraa walxaha qolka, socodka hawada dillaacyada albaabka iyo kuleylka qaboojiyaha gala. Ciyaar waxbarasho oo kaliya — ma aha talo GMP, u-hoggaansanaan ama caafimaad.

Waxa aad baran doonto

Jile

Waqti 0 min
Fasalka qolka (ISO 14644-1, ≥0.5 µm) 6.86 · Walxaha ≥0.5 µm 256 k/m³ · Farqiga cadaadiska ee wadada dhex-marta (celcelis waqti) 12.4 Pa · Beddelka hawada la bixiyay 20 · Dadka qolka ku jira 3 · Heerkulka kabaatiga qaboojiyaha -80.0 °C · Rack-ga muunadaha ugu kulul -80.0 °C · Dhaafka muunadaha −60 °C ka sarreeya (rack-daqiiqo) 0 minQolka asepticISO 6.9Bixinta 20/h · 0.45 kW○○○Hood⇡→ 12.4 PaWadadadhex-marta⇄ 0Qaboojiyaha −80 °C❄-80.0 °C1✓ -80°2✓ -80°3✓ -80°4✓ -80°QaboojiyahakaydkaSanduuqa baraf-engegan · 20.0 kgWalxaha ≥0.5 µm 256 k/m³Shaqada la qabtay iyo qorshaha 0%Rack-ga muunadaha ugu kulul -80.0 °CDhaafka muunadaha −60 °C ka sarreeya (rack-daqiiqo) 0 min
  • Rack −70 °C ama ka hooseeya
  • Rack u dhexeeya −70 iyo −60 °C
  • Rack −60 °C ka sarreeya (dhaaf)
  • Qof dhar isku-dhafan oo qolka nadiifka ah xidhan
  • Qof lab coat xidhan
  • Walxaha hawada ku jira (cabbir logaritam ah)
  • Kompareser shaqeynaya / hood la isticmaalayo
  • Kompareser joogsaday / hood sugitaan

Xakamayaal

Hawada la bixiyo oo marta shaandhooyinka HEPA ee saqafka. Hawo badan ayaa si dhakhso ah u dhalaalisa oo u nadiifisa walxaha, laakiin awoodda marawaxaddu waxay kortaa kuubka socodka. Cutub xumaaday ma bixin karo waxa aad weydiiso.

Qof kastaa wuxuu daayaa walxo; qof kasta oo gala ama baxa wuxuu furaa albaabka. Dad yar waxay sidoo kale la micno tahay shaqo yar oo la qabtay.

Dharka isku-dhafan ee qolka nadiifka waxay qiyaastii badhi ka dhigaan walxaha ≥0.5 µm ee qofku daayo marka lagu barbardhigo lab coat dharka caadiga ah dusha saaran. Beddelidda dharku waxay qaadataa qiyaastii 10 daqiiqo.

Hal albaab oo airlock ah markiiba iyo furitaanno gaagaaban: qiyaastii 10 s iyo 0.5 m³ hawada wadada dhex-marta furitaan kasta halkii ay ka ahaan lahayd 40 s iyo 2 m³. Sugidda airlock-ga waxay ku kacdaa wakhti yar.

Hawo-saarku wuxuu raacaa bixinta oo laga jarey farqigan, kaas oo ka baxa dillaacyada albaabka wuxuuna qolka ka sarreysiiyaa wadada dhex-marta. Hawo-saarku marna ma hoos u dhici karo hawo-saarka u gaarka ah ee hood-ka iyo kabaatiga badbaadada.

Wuxuu ka dhimaa hawo-saarka go'an 1100 ilaa 500 m³/h, isagoo hawo u bannaynaya cadaadiska dheeraadka ah ee qolka. Shaqada u baahan hood-ka way sugaysaa.

Wuxuu joojiyaa furitaannada caadiga ah iyo kuwa xiisaha. Furitaan kastaa wuxuu hawada kabaatiga ku beddelaa hawada qolka.

Wuxuu rack-yada u wareejiyaa meelaha bannaan ee qaboojiyaha kaydka ka dib waqtiga loo yeedhayo shaqaalaha (habeenkii ka dheer). Meelahaasi waa kaydka degdegga ah ee dhismaha, waxaana la sii daayaa kaliya qaboojiye cillad ama digniin ku jira — codsi la sameeyo inta uu weli hayo −80 °C waa la diidayaa. Rack kastaa wuxuu wadada ku qaataa qiyaastii laba daqiiqo hawada qolka.

Waxay rack-yada harsan ee qaboojiyaha ku xidhaa sanduuqyo la go'doomiyey oo baraf-engegan leh (10 kg rack kasta, inta kayd jiro). Sanduuqu wuxuu haystaa −78.5 °C inta baraf hadho.

Tilmaamayaal

Fasalka qolka (ISO 14644-1, ≥0.5 µm)
6.86
digniin
Farqiga cadaadiska ee wadada dhex-marta (celcelis waqti)
12.4Pa
caadi
Rack-ga muunadaha ugu kulul
-80.0°C
caadi
Dhaafka muunadaha −60 °C ka sarreeya (rack-daqiiqo)
0min
caadi
Walxaha ≥0.5 µm256 k/m³
Beddelka hawada la bixiyay20 1/h
Awoodda marawaxadda bixinta0.45 kW
Dadka qolka ku jira3
Shaqada la qabtay iyo qorshaha0 % · halis
Farqiga cadaadiska, albaabadu xidhan12.4 Pa
Furitaannada albaabka muddadan0
Heerkulka kabaatiga qaboojiyaha-80.0 °C
Baraf-engegga hadhay20.0 kg
Rack-yada weli qaboojiyaha ku jira4

Isbeddel

Fasalka qolka (ISO 14644-1, ≥0.5 µm): — 9.004.00

Xaaladaha dhibaatada

Heerka 1 · Ku noqoshada fasalka ka hor tallaabada aseptic

Waa 08:00. Habeenkii qolku wuxuu ku shaqeynayay hoos-u-dhigis tamar-badbaadin ah 5 beddel hawo saacaddii iyadoo hood-ku ku jiro sugitaan, qandaraasle dhar wadada ah xidhan ayaa hadda dhammeeyey shaqo gudaha ah: tirinta waxay muujinaysaa qiyaastii 3 milyan walxood m³ kasta. Lix qof oo lab coat xidhan ayaa diyaarinaya. 08:30 koox saddex-qof ah ayaa bilaabaysa tallaabo aseptic ah oo u baahan qolka ISO 7 ama ka fiican ilaa 10:00. Kooxda qolka ku hay iyo biilka marawaxadda ku hay mid macquul ah.

  • Qolka ISO 7 ama ka fiican inta tallaabada socoto oo dhan
  • Ugu yaraan saddex qof qolka ku jira inta tallaabada socoto
  • Awoodda marawaxadda bixinta celcelis ahaan ≤ 0.6 kW

Heerka 2 · Jabka qaboojiyaha habeenkii

Waa 21:00 waxaadna tahay qofka wacitaanka loo hayo. Qaboojiyaha −80 °C wuxuu hayaa afar rack oo muunado aan la beddeli karin ah. Qiyaastii 22:00 kompareserkiisu wuu istaagaa; farsamayaqaanka adeeggu wuxuu iman karaa kaliya 07:30. Qaboojiyaha kaydku wuxuu meel u leeyahay laba rack — kaydka degdegga ah ee dhismaha, oo la sii daayo kaliya qaboojiye cillad ama digniin ku jira — goobtana waxaa yaal 20 kg baraf-engegan ah, oo ku filan laba sanduuq. Wax kasta oo aad codsato, qof ayaa marka hore iman doona: qiyaastii 30 daqiiqo habeenkii. Wareegga ilaalada mar mar ayuu eegaa qaboojiyaha. SOP-ga shaybaarku wuxuu leeyahay muunad kasta ma dhaafi karto −60 °C, kooxduna waxay codsanaysaa xad badbaado: rack-yadu waa inaysan marna ka kululaan −68 °C.

  • Rack kuma dhaafo −60 °C habeenka oo dhan
  • Daqiiqo dhaafka ma jiraan dhammaadka
  • Rack-yadu marna ha ka kululaan −68 °C (xad badbaado)

Heerka 3 · Cutub hawo daciif ah, qol buuxa

Tababar gacmeed oo afar saacadood ah wuxuu leeyahay toddobo qof oo lab coat xidhan qolka ku jira iyo qulqulka joogtada ah ee marti-qaadayaasha wadada dhex-marta albaabkeeda. Toban daqiiqo ka dib, marawaxadda bixintu waxay bilaabaysaa inay jabto: waxay bixin kartaa 40 % awoodeeda oo keliya (16 beddel hawo saacaddii) ilaa dayactirka berrito. Hood-ka qiiqa waa la isticmaalayaa wuxuuna soo jiidayaa 1100 m³/h hawo-saar go'an ah. Qolka ku hay ISO 7, ku hay ugu yaraan 10 Pa wadada dhex-marta ka sarreeya, oo dhammee shaqada la qorsheeyey.

  • Qolka ISO 7 ama ka fiican
  • Farqiga cadaadiska celcelis ahaan ≥ 10 Pa
  • Shaqada la qorsheeyey waa la qabtay

Aasaas — moodelka ka dambeeya tirooyinka

Xiriir kasta oo jilaha isticmaalo, iyo ilaha uu ka yimid. Mudnaanta lagu calaamadiyay malo-awaal waa hagaajin muunad ah.

ISO 14644-1 wuxuu dejiyaa xadka fasalka cabbir walxeed kasta; hal tallaabo fasal ah waa isku-dhufasho toban. 0.5 µm, ISO 7 wuxuu oggolaadaa 352 000 walxood mitir kuuban kasta.
Cn = 10^N·(0.1/D)^2.08 ⇒ N = log10(C) + 2.08·log10(D/0.1); ISO 7 at 0.5 µm = 352 000 /m³, ISO 5 = 3 520 /m³[1]
Qol si wanaagsan isku-dhafan, walax kasta oo soo gasha ama la daayo waxaa dhalaalisa hawada la bixiyo oo la qaado; heerku wuxuu degaa meesha dhalistu ay la mid noqoto saaristu, C = G/Q.
V·dC/dt = G + Q_s·(1−η)·(f·C_out + (1−f)·C) + (Q_in + Q_door)·C_corr − (Q_s + Q_in + Q_door)·C (exact solution per 5-min tick); steady C = G/Q[5][7]
Dhibaato ka dib, dheeraadku wuxuu hoos u dhacaa si isa-sii-yaraanaya heerka beddelka hawada: hoos-u-dhac 100-jibaar ah wuxuu qaataa ln(100)/N saacadood, taas oo ah waxa baaritaanka soo kabashada ee ISO 14644-3 cabbiro.
C(t) − C∞ = (C₀ − C∞)·e^(−N·t); 100:1 recovery t = ln(100)/N (20 1/h → 13.8 min, 5 1/h → 55 min)[2][5][3]
Dadku waa isha ugu weyn. Celcelisyada la cabbiray ee ≥0.5 µm: qiyaastii 2.1 milyan daqiiqadii dharka caadiga ah, qiyaastii 1.0 milyan dharka qolka nadiifka; qof kasta iyo daqiiqad kasta way kala duwan yihiin.
G = Σ people e·exp(0.3·z − 0.045), z ~ N(0,1); e = 35 500 /s (lab coat over indoor clothing; measured for indoor clothing), 17 000 /s (cleanroom coverall), ≥ 0.5 µm[4]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Hawada farqiga ku jirta waxay ka baxdaa dillaacyada albaabka; cadaadiska looga baahan yahay in lagu riixo wuxuu kordhaa laba-jibaarka socodka. Haddii hawo-saarka go'an uu qaado wax ka badan inta bixintu ka tagto, qolku wuxuu noqdaa cadaadis-taban oo wuxuu soo jiidaa hawada wadada dhex-marta.
Q_off = Q_s − max(E_fixed, Q_s − offset); ΔP = ρ/2·(Q_off/(C_d·A))², C_d = 0.61, A = 0.02 m²; ΔP_avg = ΔP·(1 − time doors open)[6][3][5]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Albaab furan farqi cadaadis ma laha; furitaan kastaa wuxuu qolka la beddelaa hawo yar oo wadada dhex-marta ah. Furitaanno gaagaaban oo airlock-ga marayaa aad bay u yar isweydaarsadaan.
openings ~ Poisson((1·people + traffic)·Δt) + people in/out; per opening 40 s and 2 m³ of corridor air exchanged (10 s, 0.5 m³ with airlock discipline)[3][5]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Awoodda marawaxaddu waxay kortaa kuubka socodka hawada: labanlaabka beddelka hawadu wuxuu u baahan yahay qiyaastii sideed jibaar awoodda.
P = 0.45 kW·(Q_s / 1500 m³/h)³[8]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Qaboojiye aan kompareser lahayn wuxuu kululaadaa sida jidh kasta oo isku-urursan: dhakhso marka hore, ka dib gaabis marka uu u dhawaado heerkulka qolka. Joogtada waqtiga τ = C/UA ayaa dejisa saacadda.
C·dT/dt = UA·(T_amb − T) + Q_door − Q_comp; T(t) = T_amb + (T₀ − T_amb)·e^(−t/τ), τ = C/UA = 20 h; −80 → −60 °C in τ·ln(102/82) ≈ 4.4 h[9]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Furitaan kastaa wuxuu hawada qabow ee kabaatiga ku beddelaa hawo diirran oo qoyan oo qolka ah; kuleylkeeda iyo baraf-engegga ay ka dhaafto ayaa kululeeya waxa gudaha ku jira.
Q_door = 2·ρ·V_cab·c_p·(T_amb − T) (cabinet air replaced, ×2 for moisture and frost); V_cab = 0.7 m³ → ≈ 1.2 K per opening at −80 °C[9]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Muunadaha waxay raacaan deegaankooda dib-u-dhac leh; rack oo la qaado hawada qolka dhawr daqiiqo wuxuu ku kacaa dhawr darajo.
T_rack ← lag(T_rack, T_surroundings, τ = 1 h); handling: 2 min in room air with τ = 0.5 h (≈ +6 K from −75 °C); excursion = Σ racks minutes above −60 °C[9][11]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Baraf-engegku wuxuu ku dhalaalaa −78.5 °C wuxuuna nuugaa qiyaastii 573 kJ kilo kasta: sanduuqu wuxuu ku sii jiraa heerkulkaas ilaa barafku dhammaado.
chest at −78.5 °C while ice remains; dm/dt = −(UA_chest·(T_amb + 78.5) + rack heat)/573 kJ/kg[10][11]Malo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.
Joogteyaal kale oo hawlgal oo moodelku isticmaalo.
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/KMalo-awaal: cabbirka qolka, awoodda AHU, hawo-saarka go'an, aagga daadashada, waqtiyada albaabada iyo mugga la is-weydaarsaday, awoodda marawaxadda, go'doominta qaboojiyaha iyo cabbirka kompareserka, awoodda kuleylka ee rack-ga, soo-gaadhista maaraynta, sii-daynta meelaha qaboojiyaha kaydka ee degdegga oo keliya iyo xadka −60 °C ee SOP waa qiyam muunad ah oo loogu talagalay shaybaar guud; sharciyada fiisigiska iyo heerarka faafinta ee la daabacay waa sida loo xigtay.

Aan-kala-sooc: abuurahaha mulberry32 oo abuur leh; qaybinta la isticmaalay — isku-mid, tibaax (CDF rogan), caadi (Box–Muller), Poisson (Knuth). Abuurka waa la muujiyaa waana la wadaagi karaa.

Ilaha

  1. 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, 2015
  2. ISO 14644-3:2019 Cleanrooms and associated controlled environments — Part 3: Test methods (recovery test, 100:1 recovery time) — ISO, 2019
  3. 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, 2022
  4. W. 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, 2007
  5. W. 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
  6. ASHRAE Handbook — Fundamentals, ch. 16 Ventilation and Infiltration (flow through openings Q = C_d·A·√(2ΔP/ρ)) — ASHRAE, 2021
  7. EN 1822-1:2019 High efficiency air filters (EPA, HEPA and ULPA) — Part 1: Classification (H13 ≥ 99.95 % at MPPS) — CEN, 2019
  8. Fan affinity laws: flow ∝ speed, pressure ∝ speed², power ∝ speed³ — U.S. DOE — Improving Fan System Performance: A Sourcebook for Industry
  9. F. 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
  10. 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) — NIST
  11. ISBER 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

Yaa shaqadan ka shaqeeya

Moodel waxbarasho — looma isticmaalo go’aamo hawlgal. Goobaha dhabta ahi waxay joogto kasta u hagaajiyaan qalabkooda iyo xogtooda.