Kai ne manajan dakin gwaji. Ɗakin aseptic na ISO 7 mai girman 75 m³ yana samun iska daga na'urar sarrafa iska ta tace HEPA; mutane suna zubar da ɓarbashi, ƙofofi suna shigo da iskar hanyar tsakiya, kuma hood na hayaƙi yana jan fitarwa tsayayya da za ta iya sace ƙarin matsin ɗakin. A can ƙarshen hanyar tsakiya wata firiza mai ƙarancin zafi sosai tana riƙe shiryayyun samfura huɗu a −80 °C. A kowane minti biyar samfurin yana daidaita ɓarbashi a ɗakin, kwararar iska ta ratar ƙofofi da zafin da ke shiga firiza. Na'urar koyo ce kawai — ba GMP, bin ƙa'ida ko shawarar asibiti ba.
Abin da za ka koya
Dalilin da ya sa ɗaki da aka gauraya da kyau ke tsayawa a C = G/Q kuma yana murmurewa kamar e^(−N·t): mutane suna saita matakin, sauya iska yana saita gudun.
Yadda matakan matsi (pressure cascade) ke aiki a zahiri: bambanci tsakanin samarwa da fitarwa, ka'idar murabba'i ta ratar ƙofofi, da abin da buɗaɗɗun ƙofofi da fitarwar hood tsayayya ke yi masa.
Yadda firiza ta −80 °C da ta lalace ke dumama da sauri (dokar Newton), da dalilin da ya sa ake ceton samfura ta aiki a lokacin ƙararrawa, ba a lokacin iyaka ba.
Na'urar koyi
Lokaci 0 min
✓Shiryayye a −70 °C ko ƙasa
!Shiryayye tsakanin −70 da −60 °C
⚠Shiryayye sama da −60 °C (wuce gona da iri)
◍Mutum cikin rigar ɗakin tsafta
○Mutum cikin rigar dakin gwaji
•Ɓarbashi a iska (ma'aunin logarithm)
❄Compressor yana aiki / ana amfani da hood
✕Compressor ya tsaya / hood a jiran aiki
Sarrafawa
Iskar da ake samarwa ta tace HEPA na rufi. Ƙarin iska yana narkarwa da fitar da ɓarbashi da sauri, amma ƙarfin fanfo yana ƙaruwa da kubik na kwararar iska. Na'urar da ta lalace ba za ta iya bayar da abin da ka nema ba.
Kowa yana zubar da ɓarbashi; kowa da ya shiga ko ya fita yana buɗe ƙofa. Ƙarancin mutane yana nufin ƙarancin aikin da ake yi ma.
Rigunan ɗakin tsafta suna rage ɓarbashin ≥0.5 µm da mutum ke zubarwa da kusan rabi idan aka kwatanta da rigar dakin gwaji bisa tufafin yau da kullum. Sauya tufafi yana ɗaukar kusan minti 10.
Ƙofar airlock ɗaya a lokaci guda da buɗewa gajeru: kusan 10 s da 0.5 m³ na iskar hanyar tsakiya a kowace buɗewa maimakon 40 s da 2 m³. Jira a airlock yana kashe ɗan lokaci.
Fitarwa tana bin samarwa ƙasa da wannan bambanci, wanda ke ɓuɓɓugewa ta ratar ƙofofi kuma yana riƙe ɗakin sama da hanyar tsakiya. Fitarwar ba za ta taɓa faɗuwa ƙasa da fitarwar hood da akwatin aminci da kansu ba.
Yana rage fitar iskar da ba ta canzawa daga 1100 zuwa 500 m³/h, yana 'yantar da iska don ƙarin matsin ɗakin. Aikin da ke buƙatar hood yana jira.
Yana hana buɗewar yau da kullum da ta son sani. Kowace buɗewa tana maye gurbin iskar cikin firiza da iskar ɗaki.
Yana mayar da shiryayyu zuwa ramukan da ba kowa a firiza ta ajiya bayan lokacin kiran ma'aikata (ya fi tsawo da dare). Ramukan su ne ajiyar gaggawa ta ginin, ana sakin su ne kawai ga firiza mai lalacewa ko mai ƙararrawa — ana ƙin buƙata yayin da take riƙe −80 °C har yanzu. Kowane shiryayye yana yin kusan mintuna biyu a iskar ɗaki a hanya.
Yana tattara sauran shiryayyun firiza cikin akwatuna masu hana zafi da busasshen ƙanƙara (10 kg ga kowane shiryayye, gwargwadon kayan da ake da su). Akwatin yana riƙe −78.5 °C muddin ƙanƙara ta rage.
Alamomi
Ajin ɗaki (ISO 14644-1, ≥0.5 µm)
6.86
gargaɗi
Bambancin matsi da hanyar tsakiya (matsakaicin lokaci)
12.4Pa
daidai
Shiryayyen samfura mafi zafi
-80.0°C
daidai
Wuce gona da iri na samfura sama da −60 °C (mintunan shiryayye)
0min
daidai
Ɓarbashi ≥0.5 µm
256 k/m³
Sauya iska da aka bayar
20 1/h
Ƙarfin fanfon samarwa
0.45 kW
Mutane a ɗakin
3
Aikin da aka yi idan aka kwatanta da shiri
0 % · mai tsanani
Bambancin matsi, ƙofofi a rufe
12.4 Pa
Buɗe ƙofa a wannan lokaci
0
Zafin cikin firiza
-80.0 °C
Busasshen ƙanƙara da ya rage
20.0 kg
Shiryayyu da ke cikin firiza har yanzu
4
Yanayi
Yanayin rikici
Mataki 1 · Komawa aji kafin matakin aseptic
Karfe 08:00 ne. Cikin dare ɗakin ya yi aiki a saukar zafi mai tanadin makamashi na sauya iska 5 a awa tare da hood a jiran aiki, kuma ɗan kwangila da tufafin titi ya gama aiki a ciki yanzu: kidaya yana nuna kusan ɓarbashi miliyan 3 a kowace m³. Mutane shida masu rigar dakin gwaji suna shiri. A 08:30 ƙungiyar mutane uku tana fara matakin aseptic da ke buƙatar ɗakin a ISO 7 ko mafi kyau har 10:00. Riƙe ƙungiyar a ɗakin kuma ka kiyaye kuɗin fanfo cikin hankali.
Ɗaki a ISO 7 ko mafi kyau a duk matakin
Aƙalla mutane uku a ɗakin a lokacin matakin
Matsakaicin ƙarfin fanfon samarwa ≤ 0.6 kW
Mataki 2 · Lalacewar firiza da dare
Ƙarfe 21:00 ne kuma kai ne mai aiki a kira. Firiza ta −80 °C tana ɗauke da shiryayyu huɗu na samfura da ba za a iya maye gurbinsu ba. Kusan ƙarfe 22:00 compressor ɗinta yana tsayawa; ma'aikacin gyara zai iya zuwa ne kawai da ƙarfe 07:30. Firiza ta ajiya tana da wuri ga shiryayyu biyu — ajiyar gaggawa ta ginin, ana sakinta ne kawai ga firiza mai lalacewa ko mai ƙararrawa — kuma akwai busasshen ƙanƙara 20 kg a wurin, ya isa akwatuna biyu. Duk abin da ka nema, dole wani ya fara shigowa: kusan minti 30 da dare. Masu sintiri na tsaro suna leƙa cikin firizar lokaci zuwa lokaci. SOP na dakin gwajin ya ce babu samfurin da zai wuce −60 °C, kuma ƙungiyar tana neman tazarar aminci: shiryayyu kada su taɓa yin zafi fiye da −68 °C.
Babu shiryayyen da ya wuce −60 °C a duk dare
Babu mintunan wuce gona da iri a ƙarshe
Shiryayyu ba sa taɓa yin zafi fiye da −68 °C (tazarar aminci)
Mataki 3 · Na'urar iska mai rauni, ɗaki cike
Taron horo na sa'o'i huɗu na aiki yana da mutane bakwai masu rigunan dakin gwaji a ɗakin da kuma ci gaba da zuwan baƙi ta ƙofar hanyar tsakiya. Minti goma bayan farawa fanfon samarwa yana fara lalacewa: yana iya bayar da 40 % kawai na ƙarfinsa (sauya iska 16 a awa) har sai an gyara gobe. Hood na hayaƙi yana aiki kuma yana jan fitarwa tsayayya ta 1100 m³/h. Riƙe ɗakin a ISO 7, riƙe aƙalla 10 Pa sama da hanyar tsakiya, kuma a gama aikin da aka tsara.
Ɗaki a ISO 7 ko mafi kyau
Matsakaicin bambancin matsi ≥ 10 Pa
An gama aikin da aka tsara
Tushe — samfurin da ke bayan lambobin
Kowace alaƙa da na'urar koyi ke amfani da ita, tare da tushenta. Ƙayyadaddun ƙimomin da aka yi wa alama a matsayin zato daidaitawa ne na misali.
ISO 14644-1 yana saita iyakar aji ga kowane girman ɓarbashi; mataki ɗaya na aji ninki goma ne. A 0.5 µm, ISO 7 yana ba da izinin ɓarbashi 352 000 a kowace mita kubik.
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]
A ɗaki da aka gauraya da kyau kowane ɓarbashi da ya shigo ko aka zubar ana narkar da shi da iskar samarwa kuma a fitar da shi; matakin yana tsayawa inda samarwa ya yi daidai da cirewa, 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]
Bayan hargitsi ƙarin yana raguwa a hankali bisa exponential da gudun sauya iska: raguwar sau 100 tana ɗaukar ln(100)/N sa'o'i, kuma wannan shi ne abin da gwajin murmurewa na ISO 14644-3 ke aunawa.
Mutane ne babban tushe. Matsakaicin da aka auna na ≥0.5 µm: kusan miliyan 2.1 a minti a tufafin yau da kullum, kusan miliyan 1.0 a tufafin ɗakin tsafta; kowane mutum da kowane lokaci yana bambanta.
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]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Iskar bambanci tana ɓuɓɓugewa ta ratar ƙofofi; matsin da ake buƙata don tura ta yana ƙaruwa da murabba'in kwarara. Idan fitarwa tsayayyu sun ɗauki fiye da samarwa, ɗakin yana zama da matsi ƙasa da na hanyar tsakiya (matsi mara kyau) kuma yana jan iskar hanyar tsakiya ciki.
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]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Ƙofa a buɗe ba ta da bambancin matsi; kowace buɗewa tana musanya wani adadin iskar hanyar tsakiya cikin ɗakin. Gajerun buɗewa ta airlock suna musanya ƙasa da yawa.
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]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Ƙarfin fanfo yana ƙaruwa da kubik na kwararar iska: ninka sauya iska yana buƙatar ƙarfi kusan sau takwas.
P = 0.45 kW·(Q_s / 1500 m³/h)³[8]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Firiza ba tare da compressor ɗinta ba tana dumama kamar kowane lumped body: da sauri da farko, sannan a hankali yayin da take kusantar zafin ɗaki. Madaidaicin lokaci τ = C/UA yake saita agogon.
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]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Kowace buɗewa tana maye gurbin iskar firiza mai sanyi da iskar ɗaki mai dumi da danshi; zafinta da sanyin ƙanƙarar da ta bari suna dumama abubuwan da ke ciki.
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]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Samfura suna bin kewayensu da jinkiri; ɗaukar shiryayye ta iskar ɗaki na ɗan mintuna biyu yana kashe digiri da dama.
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]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Busasshen ƙanƙara yana juyewa zuwa iska a −78.5 °C kuma yana shan kusan 573 kJ a kowace kilogiram: akwatin yana tsayawa a wannan zafin har ƙanƙarar ta ƙare.
chest at −78.5 °C while ice remains; dm/dt = −(UA_chest·(T_amb + 78.5) + rack heat)/573 kJ/kg[10][11]Zato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Sauran madaidaitan aiki da samfurin ke amfani da su.
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/KZato: girman ɗaki, ƙarfin AHU, fitar iska tsayayya, fadin wuraren yoyo, lokutan ƙofa da adadin iskar da aka musanya, ƙarfin fanka, rufin firiza da girman compressor, ƙarfin riƙe zafi na shiryayyu, fallasa yayin sarrafawa, sakin ramukan firiza ta ajiya a lokacin gaggawa kaɗai da iyakar SOP ta −60 °C ƙimomin misali ne na dakin gwaji gama-gari; dokokin kimiyyar lissafi da adadin watsuwa da aka wallafa kamar yadda aka ambata ne.
Rashin tsari: mai samar da mulberry32 mai iri; rarrabawar da aka yi amfani da su — uniform, exponential (inverse CDF), normal (Box–Muller), Poisson (Knuth). Ana nuna iri kuma ana iya raba shi.
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
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
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
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