Abubuwan Da ke Tsaya A Setup Na Cleanroom

Fahimtar Alubosin Takuwar da Kuma Aikace-aikocin Muhimmi

Shi wane ne takuwa kuma menene ya zama mambobi a cikin takamfawa da aka shaidawa?

Cleanrooms suna da al'ada guda wanda aka tsara su don gudunwa da aljibiyar gishin yaukaso kamar dust, bacteria, da chemical fumes bayan da suka bin talabata da aka saka da ISO 14644. Wannan nishadi na iya yawa ga wasu asusun saboda aljibiyar gishin yaukaso na iya kawo matsalar da yawa ga wasu ƙwararun abin da suka samu. Duba misali na semiconductors wanda zankan abu da ya fi 0.5 microns yayin tsarar na iya kawo matsalar da yawa sune da ISO a shekarar 2023. Don gudunwa da wannan nishadin safa, wasu jami'ar da ke cikin wuyar na iya yawa saba wa al'ada guda, samar da farko na pressure a tsakanin wuyoyi, da kuma amincewa kan hanyoyin da mutane ke tafiya a cikin wuyar. Duk wadannan ayyukan na iya yawa don mutane da ke samarwa abubu da suka fitowa da safa ba su da aljibiyar.

Wasu asusun da suka amfani da teknolijin cleanroom: pharmaceuticals, semiconductors, da kuma biotechnology

Uku na ƙimaroyi suna amfani da teknolijin fuskantar gwiwa ne saboda koyaya da suka shafi:

• Mallamsu : Hali mai zoggo ya kamata ake ƙirƙira shayoyin da ake nefta da wasu rashin da ke cibin kaya, inda kontaminashin mikrobiyal zai iya ƙipsa rawar shi mai amfani.
• Semiconductor : Fasahar chip na elekturoniki zai buƙatar halin ISO Class 1–3 don kula daga kontaminashin nanometer scale a silicon wafers.
• Biotechnology : Wasu ƙayyade gudua kama tattara gene da wasu shakarwar jini suna buƙatar halin gwiwar gaba daya don tattare maimakon labarun.

Wasu ƙimaroyi waɗanda suka yi amfani da ISO classifications da kuma raka’i na ƙarɓar gwiwa don tattare haɗa kontaminashin da kama tattare aiki da sauri.

Sistin tasirin gwiwar gwiwa da Za’uran Ƙarɓar Gwiwa

Tattare kontaminashin da fata ya fara ta hanyar fahimtar tasirin gwiwar gwiwa da kuma za’uran aiki da gwiwar da suka haɗa. Wannan standard zai saha aiki da sauri a ƙimaroyin da suka shafi.

Tasirin Gwiwar Gwiwa na ISO (ISO 1–9) Da Kuma Kadanin Adadin Zarru

Tabani na ISO 14644-1 ya sa define zuwa ɗauƙa na farin ciki basu da kama da kiyasin aljanna. A wajin ƙarfi, ISO Class 1 ta ba da izini zuwa 12 aljanna/m³ a 0.3µm, amma ISO Class 9 ta ba da izini zuwa 1,020,000 aljanna. Kadan zuwa ƙarfi su hankali da yawa:

Iyakar da ISO 14644 Tashar da FS 209E kuma Aikacewa kan Kariya na Farmason (Girma A, B, C, D)

Tashar da ya yi da baya FS 209E ya taka guda kan yankuna na imperial kuma waɗanda guda na federal wanda muka sani da kamar waɗannan, inda ISO 14644 ce ta yi gaba daya zuwa yankuna na metric kuma wasan tsakanin tashare. Wasan farmason suna amfani da waɗannan tsarin girmawa. Muna du su na kimi. Girma A waɗanda ke kauye da ISO 5 suna wura inda ake gudanar da abubuwan da ke ƙarancin kuskure kamar yadda ake tura ciki. Waɗannan yankuna ke buƙatar 240 zuwa 480 canzawa na ginya kowanne hour. Zamma da waɗannan da ke girmar D wanda ta ISO 8. Don ayyukan da ke ƙarin kuskuren guda, suke samun 10 zuwa 25 canzawa na ginya kowanne hour. Yana iya bayyana idan muna fahimtar wane nau'in abanyan gudun girma.

Canzawa na Ginya kowanne hour (ACH) ta ISO Class kuma Aikacewa kan Tameyin Kontaminasiyon

Ƙarin yawan daga da sauri na iya kama da tsofawa. Matsayin ACH mai tsada yana nufin saukin gwiwa da kima da yawa:

Yiyan ACH masu yi da alaƙa suna da alaƙa da ƙarin yawan amfani da kima da yawa, wanda ya danna muhimmiyar ranyoyin HVAC mai amfani da kima.

Tsarin Ƙarin Ruwa, Kontrolin Tushen, da Sigogin Tsarin

Matsala Na Tsarin Ƙarshen Ƙafa Da Tsarar Ƙarshen Ƙafa A Cikin Ruwan Daga Iyaƙuƙƙa

A cikin gida kan saman da ke da ISO Class 5 ko daidai, muna ga abin da ake kira unidirectional airflow wanda aka yi amfani da HEPA a gefen ginen guda ta yin hannu tsakanin gudun gari kuma bai tsawo ba. Wannan nazarin ya taimaka wajen amincewa da ita ce babba ga tsoro na semiconductor ko gefen gudun gara a cikin shafukan da ke da shafuka. Ga cikin aljanna da ke da daraja mai tawa kamar ISO Classes 7 zuwa 9, wasu aljanna ke yi amfani da non-unidirectional ko turbulent airflow. Wannan sigar ya yi amfani da nufin ginen guda ta yin natsawa kuma suna da kyauyar biyan kudi ga aljanna da bai buƙata kama da wadannan. Don haka, sabon abun da aka gefen shirin a shekarar da shi da ta hanyar tsangar da turbulent zuwa unidirectional airflow ya kara da shidda ta hanyar ginen guda a cikin ISO 8 settings. Wannan farko ya sa biyan kudi mai iyaka yana zama babba ga wasu mai tsoro don kama da kwaliti na abin da suke tsoro.

Tsarin Aikacewa na Recirculating vs Single-Pass: Tattara da Kusurwa

Zangon 80 zuwa 90% na giniyar ginya ya dace recirculating systems, wanda ke nufin kusurwa na iyayyen HVAC kadan yayin da ke 34% saboda ASHRAE mennen sani. A wani banda, single pass systems ke ƙarɓar da ginyar ginya duka. Wannan ne za a yi wajen zaɓi idan kake aiki da abubu da ke da alhakin kaskanta ko abubu mai yawan tattara. Biotech cleanrooms misali wanda ke aiki da wannan nau'in abubuwa. Labs ke zaɓi single pass saboda son zera kwayoyin kwallon da ke tsakanin batch da experiments. Amma akwai maƙar da ke tsammanin wannan aikin aminci. Kusurwar yin aiki na single pass systems tafi naira $12.50 per square foot kowanne watan dib a cikin $7.20 kusa da recirculating systems. Wannan ke naya kusurwa sosai a makarnu mai girma.

Tabyar da Ƙimar Dabin Dama Don Karewa da Kwallen da Ba Su Daidai Ba

Cleanrooms suna da kyauyar ƙima ta +10–15 Pa a karkashin waje na gaban, tare da gradients da ke cikin sautiya da ke nufin gudun gaban daga gaban mai kyau zuwa gaban da ba shi kyau ba. Makamai da ke nufin <10% ƙima dabin dama ya karewa da shingawa ta 63% (IEST-RP-CC006.3 guidelines). EU GMP yanzu ya richi da alakar ruwa ta kyauyar mai amfani da alarma a lokacin amma a cikin takaici na B–D na farashi.

Tabyar da Alhajabi don Mutane da Abubuwa don Tacewa da Ƙimar Gaban

Alhajabi da kekere da ke cikin sautiya da 15–30 second purge cycles su tacewa da kyauyar gaban. Hanyoyi mai kyau su daba da:

• Material airlocks : Alhajabi da ke cikin sautiya da UV sanitization don alamai
• Mai gwaɗa da ɗaukaka : Ruwa masu riga da matsuka da HEPA showers
  Takaitaccen 2024 ya samar da cewa dual-stage airlocks ke kara shan cin gudunƙarwa ta 41% a karkashin single-stage.

Ila ɗin HEPA da ULPA Filters a cikin sayan ISO air purity

Filtar da HEPA su ƙara ƙirƙira da ƙimanin 99.97% na bùba da ke da girman 0.3 microns, amma ULPA filtar suna da kyau da suka fito zuwa ƙimanin kira kusa zuwa 99.999% ga bùba da girman 0.12 microns. Wannan ya sa su zama mafi kyau don kiyaye da ISO 14644 da kadan daga cikin wasu al'ada suna son. Don takaitaccen bayanin da Fuji Electric ya publishe a watan na yar huɗu, canzawa zuwa filtar da ULPA zai iya rage wafer defects a semiconductor zuwa ƙusan 18% a cikin ISO class 3 cleanrooms idan aka tura da filtar da ke aiki da HEPA kawai. Lokacin da kanka za a zaɓi tsakanin sauyi na filtar, muna buƙatar iya ganin yadda suke fitowa da air change rates. Misali, a kusan duka na ISO 5 cleanrooms suna buƙatar 240 zuwa 600 air changes per hour, wato yake nufin haka da pre-filtar da MERV 17 zuwa 20 don ninka wajen filtar da gaba daya.

Gidan Tattara da Kwayoyin Surface na Gidan

Surfaces da ba za su karɓe/karɓi ba, kuma a sauki ce su dawo: stainless steel, epoxy coatings, da kuma panels mai tsada ƙarƙashin

A cikin wucan cleanroom, surfaces dole ne su tura kuma karɓar partikulu da kuma tacewa na microbes su yi ayyuka ISO 14644 da kuma GMP. Wasu alalobin yin amfani da stainless steel saboda yake matsa kuma za a iya kirkira shi ta waye ta ƙarƙashin. Don tsakiya da kuma gaban, coatings na epoxy mai nuni na microbes tura su yi waƙoƙin contaminants na biologiji. Panels iri-iri suna da tsada ƙarƙashin kuma kafa iri na alzuma ko plastic mai girma na fiberglass. Wadannan tsari su tura su daga kamar wani irin ƙarƙashin inda gudu da microbes ke ƙarɓar. Wani abin da ke tsada girma shine yadda wadannan abubuwa ke nuna shanin chemical mai tsada girma kamar hydrogen peroxide vapor. Wannan ya dace a yin amfani da shi a cikin yankuna na pharmaceutical Grade A/B inda suke nuna tsari mai girma ta microbiological limits ko da kama 1 colony forming unit per cubic meter sannan su yi amfani da PDA guidelines na 2022.

Tsarin ƙaramin gwiwa da sauyar kwalluka, takarda da tattaren gwiwa

Matsar da kyau na fasilitin ta hanyar kwalluka, takarda da tattaren gwiwa a matsayin rukunin hanyar maimakon takaichen da kimiya. Takarda ta hanyar gwiwar HEPA ta yi aiki tare da tsofas da aka shiga a kwalluka don samar da matsayin linzamin gwiwar da mutane ke so. Don tattaren gwiwa, yawa da yawa an samar da abubuwan da suke haifar da tattaren gwiwa kamar vinyl ko epoxy resin idan aka tura su na sekin 6 zuwa 8 inch a kan takarda wanda aka yi waqo coving don kara matsar da komin da dust da abubuwan gwiwa suke tafiya. Karamin gwiwar Semiconductor suna nuna wannan abin da suke da takarda mai ƙarfi da takarda mai tushen gwiwa da takarda mai tushen gwiwa. Wannan nazarin yake iya tura gwiwa daga har zuwa 50 zuwa 70 radon a kowanne yau wanda ke nuna cewa yake da kyau idan suke so su iya samar da matsayin ISO 5 zuwa 6 don takaichen da kimiya.

Modular vs. hard-wall cleanroom construction: evaluating cost, flexibility, and compliance

Matsayin Mutane, Takkamarewa, da Tattara ta Cleanroom

Tunani na gama ɗaya na saba'ida biyu: shagunan mutane, tabatar da shagunan, da kuma tattara mai tsari. Mutane ne suke da shagunan waje, kuma bayanin nufin ya fisa cewa 60% na kwallon gwiwa dake da su ne da ke gwiwar jilbabin ko kuskurewa na amfani da shi.

Asali na kwallon gwiwa a cikin gama ɗaya: Gwiwar mutum da kuskurewa na amfani

Alhaji, gishin, da kuskurewa na yunwa suna da shaguna a 85% na kwallon gwiwa na biyu a cikin ma'ajin da aka yi rajista, don abubuwan 2023. Kuskurewa mai kwaya—kamar haka zai san yi gwiwar gloves ko zai san yi haka yawayawa—zai iya kuskure gwiwar gabanin da kuma za a iya shaguna gwiwar.

Shagunan jilbabin da kuma shagunan shigo/domin gudun ISO

Jilbabin da aka yi da ɗauka mai tsarin gwiwar gabanin ya kara 72% karancin gwiwar gabanin dib da jilbabin gama ɗaya. Tsarin gabanin gwiwar gabanin da aka yi da zaman shigo ya gabanin gabanin gabanin, amma kuma mats mai gwiwar gabanin ya kara 90% na gwiwar gabanin dake da duba domin domin.

Matsalar tarin da kara: ISO 14644, FS 209E, da IEST-RP-CC006.3

ISO 14644-1 ya fara gagarun tarin biyu a watan da ke cikin sa ISO Class 5 da aljanna. Matsalar aikin farko na amfani da IEST-RP-CC006.3 har da amfani da ita a kara. Har da yanzu a kan zarin da ke cikin wani ƙasa, FS 209E ya taka 38% na matsalar tarin da ke cikin amurka da suka yi amfani da 0.1µm.

Tarin da kara da kiyaye: abubuwa da suka yi amfani da kiyaye, filatin, da aikace-aikacen HVAC

Idan aka yi amfani da alƙawar ladar takaici na zarra da suka shiga kan tsarin al'adun gida, zai iya canza tsawon gudun zarra na takaici idan zarra suna fuskantar yawan da ke daidai. Amta HEPA idan da ta hanyar karkashin karkashin karkashi da kuma rufe karkashin HVAC kussa da 64% na mikroba a makamai da suka samar da alayyen. Sipokan da suka sami suna masu iya amfani suna kawo shaidar da kira da alif da bakwancin da suka yi amfani da tattara mai amfani da kuma tattara mai amfani da fitar da yawa. Jami'ar Ponemon tun tattare shi a cikin takaitaccen 2023.

Sashen Tambayoyi

Menene abin da ke cikin saiti na gudu?

An samar saiti na gudu don tattara halayen da ke cikin hawan ta hanyar zinza zarra na gudu kamar alhaji, bakwanci, da kuma fum na kimia. Wannan shine daidai a cikin al'ada kamar alayyen da kuma semiconductor inda zarra mai gudu zai iya kawo al'ada.

Wane al'ada ke amfani da saiti na gudu?

Uku daga cikin samin ƙarun gudun iyaye suke amfani da tasanni sosai: mai kama, semiconductor, da biotechnology. Wadannan suke buƙatar tasanni mai zurfi da kula da kewa don kara taba da amincewa na abubuwa su.

Menene ISO cleanroom classifications?

ISO classifications suna daga Class 1 zuwa 9, base su ne a cikin mituna na gwiwa. A cikin wadannan classes mai zurfi, kama ISO Class 1, ta ba da izini zuwa kewa kusa da kewa da ta buƙata tasanni sosai.

Yaya air change rates suke taka leda kan cleanrooms?

Air change rates (ACH) suke taka leda kan kula da kewa saboda suke canza velocity da frequency na gwiwa, wanda ke taimakawa wajen kewa. ACH levels na gaskiya suke tsayawa tsakanin kara da kewa da kewayon alika.

Menene modular da hard-wall cleanrooms?

Modular cleanrooms suna ba da tsari mai iya canzawa da kewayon kudin basu kuma sai ba za su iya kewa da kewa kamar hard-wall cleanrooms, wanda suke ba da kewayon kara da kewa, da ke buƙatar iyaye na ISO mai zurfi.