Gidan Kudin Karami da Gidan Kudin Karamin Karami: Ma'anar Su, Farkon Su da Yadda Ake Amfani Da Su

Bayanin Dukkan: Wani ne 'Sterile' da 'Clean Rooms' suka kunna?

Makamun Da Karami: Makamun Da Karami Don Gudanin Tushen (Kulliyar ISO 14644-1)

Makamun da karami shi ne makamun da aka saita da karami don gudanin tushen da karami a cikin hawa—ba tushen mikrobiyolohi. Ya haɗa da ISO 14644-1, wanda ya kammala karamin hawa ta hanyar yadda za a sanya tushen da karami a cikin metru kubik (misali, ISO Class 5 ya ba damu ≤3,520 tushen da karami ≥0.5 µm/m³). Bayanin karamin da aka saita su ne:

• Gudanin hawa da HEPA , wanda ya gudanin 99.97% na tushen da karami ≥0.3 µm
• Farko na karamin hawa , wanda ya haɗa da rukunin hawa da karami don kare kariya na tushen da karami
• Sufurin da ba su daga tushen da karami , daga dindin da karamin da karami har zuwa abubuwan da suka saita da karamin da karami

Kamarun da suka fuskanta a cikin kula da abubuwan da suka ƙare (particles) a jihadi, ba a matsayin su kamar yadda ake bukatar su a tsarin samar da semiconductor, aikin haɗawa na al'adu na tibbi, da optics mai kyau—indaa kuma dust na nanoscale zai iya gyara aiki ko kuma yadda ake samar da abubuwa. Kamar da suka fuskanta abubuwan da suka ƙare a lokacin da suka fuskanta (real-time particle counters) suna ƙara amfani da koyaushe don tabbatawa cikin koyaushe da koyaushe na ISO.

Kamarun Da Zuciya: Al'ada Mai Amfani Ga Kullumta Na Mikroba (EU GMP Annex 1, USP <1211>)

Kamarun da zuciya shi ne da koyaushe wani karamin kamarun da suka fuskanta—da aka saita ba hanya ta hanyar kula da abubuwan da suka ƙare kuma kuma kulla mikroba da suka dace (viable microorganisms) ta hanyar ayyukan da suka dace da suka rubuta, a cikin koyaushe na EU GMP Annex 1 da USP <1211>, ya samu 'sterility assurance level' (SAL) na ≤10⁻³ ta hanyar:

• Tsarin rufe mai sauƙi (Unidirectional laminar airflow) , wanda ke gina da ULPA filters (99.999% efficient at 0.12 µm)
• Kula da al'ada ta hanyar koyaushe mai kyau , duk da settle plates, active air sampling, da surface bioburden testing
• Ayyukan da suka koyaushe na kulla , kamar yadda ake amfani da hydrogen peroxide mai tsoro (VHP) da kafaƙin gudunmawa na mutane daidai

Bayan gudunmawa na umummi, gudunmawa mai tsoro yana bukatar simulasu na media—yadda ake gudan gudunmawa ta hanyar ƙananan gudunmawa wanda ake amfani da media na rarraba—don nuna tushen aikin aseptic. Don gudunmawa mai tsoro na ISO Class 5, alama na dandara suka fofa ≥240 yadda ake canza hawayi kafin saurin hawayi da kuma kare tsoron mikroba, wanda ya taimaka ga karamin mutane a cikin gudunmawa na aseptic na sayarwa na sayarwa.

Gudunmawa mai tsoro vs Gudunmawa na umummi: Farko na tekniki da aiki

Kafaƙin hawayi da filtar: HEPA vs. ULPA, Canzawa na hawayi, da kafaƙin ƙananan hawayi

Sistemu na HVAC don gida mai kariya suka yi amfani da wata farko daga cikin wadanda suka yi amfani da gida mai kariya. Farko na farko yana a cikin abin da suka bukatar tsarin - wani ya yi iyi ne don kare rashin tashar, kuma wani ya yi iyi ne don kare mikroba duk akwai. Wadannan biyu suka yi amfani da filtara na yadda mafi kyau, amma gida mai kariya suka faru da ULPA filtara wadanda suka kare 99.999% na tashar wadanda suka zama 0.12 microns. Wannan shine mafi kyau da filtara na HEPA wadanda suka kare 99.97% na tashar wadanda suka zama 0.3 microns. Wannan tsarin kare mafi kyau ya sa ita zai kare tashar wadanda suka zama kamar virus kuma kuma karama na bakteriya, wanda shine babu kafin yanzu don kare gida mai kariya a laburaturi ko a fasiliti na sayenshi.

Ramar yadda ƙarfi na hawa ta canza tana canza a cikin kowane tsarin gida. Misali, gida mai saukin hawa na ISO Class 7 yana bukatar ƙarfi na hawa da yawa a cikin sa'a 20. Zonin da suka dace da kariya (Sterile Grade A/B) suna bukatar ƙarfi na hawa ne a cikin sa'a 40 zuwa 60. Gidan da suka dace da kariya mai yawa (ISO 5 sterile suites) yana bukatar ƙarfi na hawa da yawa a cikin sa'a 240 don amfani da tsarin hawa mai saukin kariya (laminar flow) kuma don gyara kariya na bakteriya ko mikroba a lokaci mafi kyau. A matsayin farko na farko na hawa (pressure differentials), alama suka zama mafi kariya. Gidan da suka dace da kariya (sterile suites) yana bukatar farko na hawa (pressure difference) ta yawa a cikin +15 Pa a tsakanin zonin, amma gida mai saukin hawa na sarari (standard cleanrooms) yana amfani da farko na hawa a cikin +10 zuwa +15 Pa. Wadannan farko na hawa (pressure gradients) suka taimaka wajen samun tsarin hawa mai saukin kariya (steady one-way airflow pattern) wanda ya taimaka wajen rarraba abubuwan da suka dace da kariya (particles) da mikroba daga wurin da suka dace da kariya (sensitive operations).

Tasfir da Tsarin Kula: Kira Abubuwa da Kira Tashin Mabukata da Kira Tashin Media

Falsafar tasfir ya fara kuma ya daga cikin kariya: gida na saukarwa suka yi amfani da kira abubuwa na tsaki da kira abubuwa na yanzu a cikin ISO 14644-1, amma gida na tashin mabukata suka yi amfani da kira tashin mabukata a cikin EU GMP Annex 1. binciken kira abubuwa na tsaki da kira abubuwa na yanzu suka yi amfani da kira tashin mabukata a cikin EU GMP Annex 1. da koyaushe kira abubuwa na tsaki da kira abubuwa na yanzu zai kasance babban wuri—amma a gida na tashin mabukata, zai kasance wani alama na tsarin rufe na hawa, ba wani karamin kara ba.

Karamin tashin mabukata mai mahimmanci yana bukatar bayanin biyologiku na fadakawa:

• Kira tashin mabukata ta hanyar plates na tsaki, plates na kuskus, da samplers na hawa na yanzu
• Kira tashin media , wanda aka yi kowane shidda, yana kuma kara aiki na asetonik na yanzu ta hanyar broth na nutrisi na mabukata don gano karamin kara na mabukata
• Kira tashin ATP bioluminescence , ake amfani da shi don ƙarshen, amfani da yadda ake gano kuma ƙarshen yadda ake gano ƙwayoyin da suka dace da sauyi

Wata ma'ana, al'adu na cleanrooms ba su da kariya ba, kuma suka yi amfani da particle qualification ta 'yan shekara, kuma ba a bukatar testing na viability ko process simulation ba. Wannan framework na validation na biyu ya zama tushen cikin da suka dace da SAL ta ≤10⁻³—wacce ke nuna cewa ba a zama da wani unit ba da kariya ba ne a cikin 1,000 da aka shiga.

Al'amari na Sana'a: Idan za a amfani da sterile room ko clean room

Sana'ar da Pharmaceutical Aseptic: Idan Grade A/B Environments suna bukatar Sterility Assurance

Kamar yadda ake amfani da asirin da suka daga cikin jini, kuma asirin da suka daga cikin biyoyi, kuma asirin da suka daga cikin biyoyin tattalin arziki, kama iya gudanar da shari‘a ta hanyar fuskanci saboda yadda al’umma na bakteriya zai iya haifar da tsoro na umurni wanda zai iya haifar da mutuwa. Al’adu da aka bayyana suka yi amfani da EU GMP Annex 1 sun nuna yadda ake bukatar karamin gida mai kyau don samun asirin da suka daga cikin biyoyi. A matsayin kusur, karamin A (wanda ya zama karamin ISO 5) kuma karamin B (wanda ya zama karamin ISO 7) suka kashe a lokacin yadda ake sanya asirin a cikin kankara ko yadda ake yin freeze drying. Kullum gida suka hada abubuwan da suka daga cikin tsarin hanyar yin rufe, filtarin da suka daga cikin rufe mai yawa, hanyar yin fasahar da hydrogen peroxide, kuma abinci da suka daga cikin rufe mai yawa don masu amfani. Duk wadannan hanyoyi suka kashe a yin amfani da media fill tests kuma a saba a yin amfani da tsarin yin amfani da al’umma a lokacin da suka daga cikin rufe.

Kamar yadda ake gani, kuma koyaushe ne da kula ga tashin abu ba sufi. A cikin bayanai da FDA ya nuna, yayin da aka saba waɗanda suka yi amfani da bayanan da aka rubuta, akwai ƙarshen 60% na dukkan abubuwan da suka shiga wajen kariya da kariya (sterile) suka fuskata ne daga tashin mikroba ba daga abubuwan da suka shiga wajen kariya (particles) ba. Wannan yana nuna saboda yadda al'adu da kariya (sterile environments) suka bukatar karin abubuwa da suka fi daga abubuwan da ISO 14644-1 ta ba su. Lokacin da muke ganin abubuwan da suka dace, al'adu da kariya (cleanrooms) suna amfani da su ne kamar wani baya da yawa don samun abubuwa. Amma kariya mai sauƙi (true protection) daga tashin abubuwa (contamination) yana dace da kariya mai sauƙi (sterile rooms) da suka dace. Wadannan al'adu da kariya (specialized spaces) suna aiki kamar wani hanyar kariya (safeguards) da suka fi daga abubuwan da suka dace don kariya (product safety).

Semi-kundaktar da Ingilishi mai sauƙi: Inda Tashin Abubuwa (Particle Control) Ya Fi Kariya (Sterility)

Kamfanin kuma aikin samun wani abu mai yawa na semiconductor ya kashe shi ne daga wadannan karama na gaba daya na micron ba tare da fuskanci akan mikrobu ba. Karamar hankali na 0.1 micron zai iya saita karamar transistor kuma zai kawo mazaigari ga silikon wanda zai kama da kudin $50,000. Don hakan, akwai karamin fabrikasi na musamman suka yi aminci a cikin cleanroom na ISO Class 3 zuwa 5 wanda suka saita ULPA filters. Su ka tsaya aiki na hanyar tsayayen hawa ta hanyar turbulent ko laminar flow systems, wacce suka yi a matsayin abubuwan aikin su ne a cikin jihun su. Aikin tsayayen abubuwa suka yi a matsayin amalan da ke cikin shari'a. Amma, ba su da alaƙa da cleanroom na biyologikal, duk wadannan gida ba su da bukatar amfani da amfanin da ke cikin shari'a don fuskancin mikrobu, amfanin da ke cikin shari'a don abubuwan da suka yi aminci, ko kamar yadda za a yi sterilization bayan karama.

A cikin al'adu kamar tsarin sayarwa na linsun optikal da kuma saukar da abubuwan gaba daya na aerospace, yadda ake nuna karamin yawan abubuwa wanda suka daga nanoscale yana da mahimmanci don zanen karamin yawan abubuwan gaba daya na nanoscale. Mikrobu ba su kashe wani abu a wannan hanyar kuma, saboda haka shi ne ya zama babu manufa a yadda ake sanya kudin kafin kasa ga al'adu na sterilization saboda yana zama karamin kudin da karamin fahimtar wanda ba za a iya amfani da shi ba. Lokacin da ake fito akan yadda ake yi amfani da al'adu na sterilization ko ake amfani da al'adu na clean room, masu sayarwa suka bukata daga cikin ruwa suka duba wani abu wanda suka nuna yadda suka daga nan. Idan biyologiya ce abin da ke bawa kari, to suna bukatar amfani da al'adu na validation, amfani da monitoring mai zuwa, da kuma amfani da al'adu na intervention. Amma idan ake so abubuwan da suka daga gaba daya, to yadda ake so al'adu na classification system, al'adu na filtration na hawa, da kuma al'adu na containment yana da mahimmanci daga yadda ake so al'adu na amfani da shi da yadda ake so al'adu na kudin.

Tambayoyi Masu Yawan Faruwa

Shin yana farko tsakanin 'clean room' da 'sterile room'?

A 'clean room' ya zama cikin karewa na karamin fassarar da abubuwan da suka fi gaba (airborne particulate contamination) kuma ya dace da standaradun ISO 14644-1. Amma a 'sterile room' ya zama cikin karewa na karamin karamin halayen da suka fi gaba (microbial presence) kuma ya dace da saratu masu karami, kamar EU GMP Annex 1, wanda ke bukatar al'ummar da suka fi gaba da 'sterility assurance level (SAL)'

Kamar yasa karamin halayen da suka fi gaba (microbial monitoring) yana da mahimmanci a cikin 'sterile rooms'?

Karamin halayen da suka fi gaba (microbial monitoring) yana da mahimmanci a cikin 'sterile rooms' don ganin cewa ba kowane halaya da suka fi gaba (viable microorganisms) wanda za ta iya karewa ga kyautar hanyar amfani da abubuwa (product safety), kamar a sana'ar 'pharmaceuticals' inda fassarar da abubuwan da suka fi gaba (contamination) zai iya haifar da karamin halayen da suka fi gaba (serious health risks).

Yaya lokacin da 'sterile room' zai amfani ne kafin 'clean room'?

Kudin da suka ƙarewa suna da mahimmanci ga wani amfani wanda yana bukatar karewa ta karshe, kamar tsarin sayar da abubuwan da suka daga jiki ko abubuwan da suka daga hanyar biyologiya, amma kudin da suka ƙarewa ba su da mahimmanci a cikin sayar da semiconductor ko optics mai kyau, inda kula da kudin da suka ƙarewa shine babban muhimmincin.