"Zosavuta" sizingakhale mawu omwe amabwera m'maganizo popanga malo ovuta ngati awa. Komabe, izi sizikutanthauza kuti simungathe kupanga choyeretsa cholimba pothana ndi zovuta motsatana. Nkhaniyi ikukhudza gawo lililonse lofunikira, mpaka ku maupangiri okhudzana ndi momwe mungasinthire kuwerengera katundu, kukonzekera njira zotulutsira, komanso kuwongolera malo opangira zipinda zofananira ndi kalasi yapachipinda choyeretsa.
Njira zambiri zopangira zinthu zimafunikira malo okhwima omwe amaperekedwa ndi chipinda choyeretsa. Chifukwa chakuti zipinda zoyeretsera zimakhala ndi makina ovuta komanso okwera mtengo, ogwiritsira ntchito, ndi magetsi, ndikofunika kupanga mapangidwe a zipindazo motsatira ndondomeko. Nkhaniyi ipereka njira yowunikira ndi kupanga zipinda zoyeretsera, kuwerengera anthu / kutuluka kwa zinthu, kugawika kwaukhondo wa danga, kuponderezedwa kwa mlengalenga, kutulutsa mpweya wamlengalenga, kutulutsa mpweya wamlengalenga, mlengalenga wamlengalenga, zosintha zomwe ziyenera kuwunikiridwa, kusankha kwamakina, kuwerengera katundu wotenthetsera / kuziziritsa, komanso zofunikira za malo.
Khwerero 1: Yang'anirani Mapangidwe a Anthu/Kuyenda Kwazinthu
Ndikofunikira kuunika anthu komanso kuyenda kwa zinthu m'chipinda choyera. Ogwira ntchito m'chipinda chaukhondo ndiye gwero lalikulu kwambiri loipitsira zipinda zaukhondo ndipo njira zonse zofunikira ziyenera kulekanitsidwa ndi zitseko ndi njira za ogwira ntchito.
Malo ovuta kwambiri ayenera kukhala ndi mwayi umodzi kuti danga lisakhale njira yopita kumalo ena, osafunikira kwambiri. Njira zina zopangira mankhwala ndi biopharmaceutical zimatha kuipitsidwa ndi njira zina zamankhwala ndi biopharmaceutical. Njira zoyipitsidwa m'njira zosiyanasiyana ziyenera kuwunikiridwa mosamalitsa za njira zolowera ndi zosungira, kudzipatula kwazinthu zakuthupi, ndi njira zomalizidwa zotuluka ndi zosungira. Chithunzi 1 ndi chitsanzo cha malo a simenti ya mafupa omwe ali ndi njira zovuta kwambiri ("Solvent Packaging", "Bone Cement Packaging") malo omwe ali ndi mwayi umodzi ndi zotsekera mpweya monga ma buffers kumalo okwera anthu ogwira ntchito ("Gown", "Ungown").
Khwerero 2: Dziwani Masanjidwe a Ukhondo wa Malo
Kuti muthe kusankha gulu la zipinda zoyera, ndikofunikira kudziwa mulingo woyambira wa zipinda zoyera komanso zomwe zimafunikira paukhondo uliwonse. Institute of Environmental Science and Technology (IEST) Standard 14644-1 imapereka magulu osiyanasiyana aukhondo (1, 10, 100, 1,000, 10,000, ndi 100,000) ndi chiwerengero chovomerezeka cha tinthu tating'onoting'ono tosiyanasiyana.
Mwachitsanzo, chipinda choyera cha Class 100 chimaloledwa kupitirira 3,500 particles/cu ft ndi 0.1 microns ndi zazikulu, 100 particles/cubic ft. pa 0.5 microns ndi zazikulu, ndi 24 particles/cubic ft. pa 1.0 microns ndi zazikulu. Gome ili limapereka kuchuluka kwa tinthu kololedwa ndi mpweya pagulu lililonse laukhondo:
Kugawika kwa ukhondo wa malo kumakhudza kwambiri kamangidwe ka zipinda zoyera, kukonza, ndi mtengo wamagetsi. Ndikofunika kuwunika mosamala kuchuluka kwa kukana / kuipitsidwa pamagulu osiyanasiyana aukhondo komanso zofunikira zamabungwe owongolera, monga Food and Drug Administration (FDA). Nthawi zambiri, njirayo ikakhudzidwa kwambiri, m'pamenenso ukhondo uyenera kugwiritsidwa ntchito. Gome ili limapereka magawo aukhondo panjira zosiyanasiyana zopangira:
Kupanga kwanu kungafunike gulu lokhazikika laukhondo malinga ndi zofunikira zake. Samalani pogawa magawo aukhondo pa malo aliwonse; payenera kukhala mitundu iwiri yosiyana ya kukula kwa ukhondo pakati pa malo olumikizirana. Mwachitsanzo, n’kosaloleka kuti chipinda choyera cha M’kalasi 100,000 chitsegulidwe m’chipinda choyera cha M’kalasi 100, koma n’chovomerezeka kuti Chipinda choyera cha M’kalasi 100,000 chitsegulidwe m’chipinda choyera cha M’kalasi 1,000.
Kuyang'ana malo athu olongedza simenti ya mafupa (Chithunzi 1), "Mkanjo", Ungown" ndi "Kupaka komaliza" ndi malo ofunikira kwambiri ndipo ali ndi gulu laukhondo la Gulu la 100,000 (ISO 8), "Bone Cement Airlock" ndi "Osabala Airlock" lotseguka kumalo ovuta komanso kukhala ndi Gulu 0 (Cenessification 7); Packaging” ndi njira yovuta kwambiri ndipo ili ndi gulu laukhondo la Class 10,000 (ISO 7), ndipo 'Solvent Packaging' ndi njira yovuta kwambiri ndipo imachitika mu Class 100 (ISO 5) laminar flowhoods m'chipinda choyera cha Class 1,000 (ISO 6).
Khwerero 3: Tsimikizirani Kupanikizika Kwapamlengalenga
Kusunga mpweya wabwino wa mpweya, mogwirizana ndi malo oyandikana nawo aukhondo, ndikofunikira kuti zonyansa zisalowe m'chipinda choyera. Ndikovuta kwambiri kusunga ukhondo wa danga nthawi zonse pamene ili ndi kuponderezedwa kopanda ndale kapena koipa. Kodi kusiyana kwa danga pakati pa mipata kukhale kotani? Kafukufuku wosiyanasiyana adawonetsa kulowerera kwa koyipitsidwa muchipinda choyera ndi kusiyana kwapakati pakati pa chipinda choyera ndi malo oyandikana nawo osalamulirika. Maphunzirowa adapeza kusiyana kwapakati pa 0.03 mpaka 0.05 mu wg kuti ikhale yothandiza kuchepetsa kulowetsedwa koipa. Kusiyana kwa kuthamanga kwa mlengalenga pamwamba pa 0.05 in. wg sikupereka mphamvu zowononga zowononga kuposa 0.05 in. wg
Kumbukirani, kusiyana kwapamwamba kwa mlengalenga kumakhala ndi mtengo wapamwamba wa mphamvu ndipo kumakhala kovuta kwambiri kuwongolera. Komanso, kusiyanitsa kwakukulu kumafunikira mphamvu zambiri pakutsegula ndi kutseka zitseko. Kusiyanitsa kwakukulu kovomerezeka pakhomo ndi 0.1 in. wg ku 0.1 in. wg, khomo la 3 phazi ndi 7 phazi limafuna mapaundi a 11 kuti atsegule ndi kutseka. Malo oyeretsera angafunikire kukonzedwanso kuti asunge kusiyana kwa kuthamanga kwapakati pazitseko zovomerezeka.
Malo athu oyikamo simenti ya mafupa akumangidwa mkati mwa nyumba yosungiramo zinthu yomwe ilipo, yomwe ili ndi mphamvu yapakati (0.0 in. wg). Chotsekera mpweya pakati pa nyumba yosungiramo katundu ndi "Gown / Ungown" sichikhala ndi ukhondo wa danga ndipo sichikhala ndi malo okhazikika. "Gown / Ungown" idzakhala ndi danga la pressurization ya 0.03 in. wg "Bone Cement Air Lock" ndi "Sterile Air Lock" idzakhala ndi danga la 0.06 in. wg "Final Packaging" idzakhala ndi danga la 0.06 in. wg "Bone Cement Packaging, 03". kuthamanga kuposa 'Bone Cement Air Lock' ndi "Final Packaging" kuti mukhale ndi fumbi lopangidwa panthawi yolongedza.
Mpweya wosefera mu "Bone Cement Packaging" umachokera ku danga lomwe lili ndi ukhondo womwewo.Kulowa kwa mpweya sikuyenera kuchoka kumalo osungira ukhondo kupita kumalo osungira ukhondo. zovuta "Zosungunulira Packaging" ndi "Wosabala Air Lock" ndi 0.05 in. wg Kuthamanga kwa danga kwa 0.11 in. wg sikudzafuna kulimbitsa mwapadera kwa makoma kapena kudenga.
Khwerero 4: Tsimikizirani Space Supply Airflow
Gulu la ukhondo wa danga ndilo kusintha kofunikira pakuzindikiritsa kayendedwe ka mpweya ka chipinda choyera. Kuyang'ana pa tebulo 3, gulu lililonse loyera limakhala ndi kusintha kwa mpweya. Mwachitsanzo, chipinda choyeretsa cha Class 100,000 chili ndi ma ach 15 mpaka 30. Kusintha kwa mpweya wa cleanroom kumayenera kutengera zomwe zikuyembekezeredwa mkati mwa chipinda choyeretsa. Chipinda choyeretsera cha Gulu 100,000 (ISO 8) chokhala ndi anthu ochepa, njira yochepetsera tinthu tating'onoting'ono, komanso kukhathamiritsa kwamalo molingana ndi malo oyandikana nawo aukhondo atha kugwiritsa ntchito 15 ach, pomwe chipinda choyeretsa chomwechi chokhala ndi anthu ambiri, kuchuluka kwa magalimoto, kutulutsa tinthu tambiri, kapena kusalowerera ndale kungafune 30 danga.
Wopangayo amayenera kuwunika momwe angagwiritsire ntchito ndikuzindikira kuchuluka kwa mpweya woti agwiritse ntchito. Zosintha zina zomwe zimakhudza kayendedwe ka mlengalenga ndi mpweya wotulutsa mpweya, mpweya wolowera mkati kudzera pazitseko / zotseguka, ndi mpweya wotuluka pazitseko/zotsegula. IEST yasindikiza mitengo yosinthira mpweya mu Standard 14644-4.
Kuyang'ana Chithunzi 1, "Chovala / Chopanda Chovala" chinali ndi maulendo ambiri mkati / kunja koma si malo ovuta kwambiri, zomwe zimapangitsa kuti 20 a ch., 'Sterile Air Lock' ndi "Bone Cement Packaging Air Lock" ali pafupi ndi malo ovuta kupanga komanso ngati "Bone Cement Packaging Air Lock". ali ndi malire olowera mkati / kunja ndipo alibe njira zopangira zinthu, kufunikira kwawo kofunikira monga chotchinga pakati pa "Mkanjo/Ungown" ndi njira zopangira zomwe zimapangitsa kuti akhale ndi 40 ach.
"Final Packaging" imayika matumba a simenti / zosungunulira mafupa mu phukusi lachiwiri lomwe silili lovuta ndipo limabweretsa 20 ach rate. "Bone Cement Packaging" ndi njira yovuta ndipo ili ndi 40 ach rate. 'Solvent Packaging' ndi njira yovuta kwambiri yomwe inachitika mu Class 100 (ISO 5) laminar flow hoods mkati mwa chipinda choyera cha Class 1,000 (ISO 6). 'Solvent Packaging' ili ndi maulendo ochepa kwambiri olowera / kunja komanso kutsika kwapang'onopang'ono, zomwe zimapangitsa kuti 150 ach rate.
Gulu Loyera ndi Kusintha Kwa Air Paola
Ukhondo wa mpweya umatheka podutsa mpweya kudzera muzosefera za HEPA. Nthawi zambiri mpweya umadutsa muzosefera za HEPA, tinthu tating'onoting'ono timatsalira mumlengalenga. Kuchuluka kwa mpweya wosefedwa mu ola limodzi kugawidwa ndi kuchuluka kwa chipinda kumapereka chiwerengero cha kusintha kwa mpweya pa ola limodzi.
Zomwe tafotokozazi za kusintha kwa mpweya pa ola limodzi ndi lamulo la kapangidwe kake. Ayenera kuwerengedwa ndi katswiri wa HVAC cleanroom, monga mbali zambiri ziyenera kuganiziridwa, monga kukula kwa chipinda, chiwerengero cha anthu omwe ali m'chipindamo, zipangizo zomwe zili m'chipindamo, njira zomwe zikukhudzidwa, kuwonjezeka kwa kutentha, ndi zina zotero.
Khwerero 5: Dziwani Mayendedwe a Mlengalenga Wamlengalenga
Zipinda zambiri zaukhondo zimakhala ndi mphamvu yabwino, zomwe zimapangitsa kuti mpweya wokonzekera ulowe m'malo oyandikana nawo omwe amakhala ndi kutsika kocheperako komanso kutulutsa mpweya wosakonzekera kudzera m'malo opangira magetsi, zowunikira, mafelemu a zenera, mafelemu a zitseko, mawonekedwe a khoma / pansi, mawonekedwe a khoma / denga, ndi zitseko zolowera. Ndikofunikira kumvetsetsa kuti zipinda sizimasindikizidwa ndipo zimatayikira. Chipinda chotsuka bwino chizikhala ndi 1% mpaka 2% voliyumu yotayikira. Kodi kutayikira uku ndikoyipa? Osati kwenikweni.
Choyamba, ndizosatheka kukhala ndi zero kutayikira. Chachiwiri, ngati mukugwiritsa ntchito zida zowongolera mpweya, zobwerera, komanso zotulutsa mpweya, payenera kukhala kusiyana kwa 10% pakati pa kuperekera ndi kubweza mpweya kuti muchepetse kuperekera, kubwerera, ndi kutulutsa mpweya wina ndi mzake. Kuchuluka kwa mpweya wotuluka pazitseko kumadalira kukula kwa zitseko, kusiyana kwa kupanikizika pakhomo, ndi momwe chitseko chatsekedwa bwino (ma gaskets, madontho a zitseko, kutsekedwa).
Tikudziwa kuti mpweya wokonzekera / kutulutsa mpweya umachokera ku danga kupita kumalo ena. Kodi kutulutsa kosakonzekera kumapita kuti? Mpweya umatulutsa mkati mwa danga la stud ndi kunja pamwamba. Kuyang'ana polojekiti yathu yachitsanzo (Chithunzi 1), kutuluka kwa mpweya kudzera pakhomo la 3- ndi 7- phazi ndi 190 cfm ndi kusiyana kwapakati pa 0.03 mu wg ndi 270 cfm ndi kusiyana kwapakati pa 0.05 in. wg
Khwerero Chachisanu ndi chimodzi: Dziwani Zam'mlengalenga Air Balance
Kuchuluka kwa mpweya wa mlengalenga kumaphatikizapo kuwonjezera mpweya wonse mu danga (kupereka, kulowetsa) ndi mpweya wonse womwe umachoka m'malo (kutulutsa, kutuluka, kubwerera) kukhala wofanana. Kuyang'ana malo opangira simenti ya mafupa (Chithunzi 2), "Solvent Packaging" ili ndi 2,250 cfm supply airflow ndi 270 cfm of air exfiltration to 'Sterile Air Lock', zomwe zimapangitsa kuti mpweya wobwereranso ukhale 1,980 cfm. 'Solvent Packaging', ndi 190 cfm exfiltration kupita ku "Gown/Ungown", zomwe zimapangitsa kuti mpweya ubwerere wa 370 cfm.
"Bone Cement Packaging" ili ndi 600 cfm supply airflow, 190 cfm ya kusefedwa kwa mpweya kuchokera ku 'Bone Cement Air Lock", 300 cfm fumbi lotolera mpweya, ndi 490 cfm ya mpweya wobwerera. 670 cfm kuperekera mpweya, 190 cfm exfiltration ku "Gown/Ungown". "Final Packaging" ili ndi 670 cfm supply air, 190 cfm exfiltration to 'Gown/Ungown', ndi 480 cfm ya mpweya wobwerera. "Gown/Ungown" ili ndi 480 cfm of supply air, 570 cfm infiltration, 190 cfm ndi 860 air return.
Tsopano tatsimikiza za kupezeka kwa zipinda zoyeretsera, kulowa, kutulutsa, kutulutsa, ndi kubweza mpweya. Mpweya womaliza wobwerera kumlengalenga udzasinthidwa panthawi yoyambira kuti mutulutse mpweya wosakonzekera.
Khwerero 7: Yang'anani Zosintha Zotsalira
Zosintha zina zomwe ziyenera kuyesedwa ndi:
Kutentha: Ogwira ntchito m'chipinda chaukhondo amavala zofukiza kapena masuti abuluu atavala zovala zawo zanthawi zonse kuti achepetse kubadwa kwa tinthu ting'onoting'ono komanso kuipitsidwa komwe kungachitike. Chifukwa cha zovala zawo zowonjezera, ndikofunika kusunga kutentha kwa malo otsika kuti antchito atonthozedwe. Kutentha kwapakati pa 66 ° F ndi 70 ° kumapereka malo abwino.
Chinyezi: Chifukwa cha mpweya wochuluka wa chipinda choyeretsa, magetsi akuluakulu amapangidwa. Pamene denga ndi makoma ali mkulu electrostatic mlandu ndi danga ndi otsika chinyezi wachibale, airborne particulate adzadziphatika pamwamba. Chinyezi chikachulukirachulukira, ma electrostatic charge amatulutsidwa ndipo zinthu zonse zomwe zagwidwa zimatulutsidwa pakanthawi kochepa, zomwe zimapangitsa kuti chipinda choyeretseracho chizisowa. Kukhala ndi ma electrostatic charge kumatha kuwononganso zida za electrostatic discharge. Ndikofunikira kusunga danga la chinyezi chokwanira kuti muchepetse kuchuluka kwa ma electrostatic charge build-up. RH kapena 45% +5% imatengedwa kuti ndi mulingo woyenera kwambiri wa chinyezi.
Laminarity: Njira zovuta kwambiri zingafunike kuyenda kwa laminar kuti muchepetse mwayi woti zowononga zilowe mumtsinje wa mpweya pakati pa fyuluta ya HEPA ndi ndondomekoyi. IEST Standard #IEST-WG-CC006 imapereka zofunikira pakuwongolera mpweya.
Electrostatic Discharge: Kupitilira mlengalenga, njira zina zimakhudzidwa kwambiri ndi kuwonongeka kwa electrostatic discharge ndipo ndikofunikira kukhazikitsa pansi conductive pansi.
Magawo a Phokoso ndi Kugwedezeka: Njira zina zolondola zimakhudzidwa kwambiri ndi phokoso ndi kugwedezeka.
Khwerero Chachisanu ndi chitatu: Dziwani Mawonekedwe a Mechanical System
Pali zinthu zingapo zomwe zimakhudza dongosolo la makina a cleanroom: kupezeka kwa malo, ndalama zomwe zilipo, zofunikira za ndondomeko, gulu laukhondo, kudalirika kofunikira, mtengo wamagetsi, zizindikiro zomanga, ndi nyengo yaderalo. Mosiyana ndi makina anthawi zonse a A/C, makina oyeretsera a A/C ali ndi mpweya wochulukirapo kuposa momwe amafunikira kuti akwaniritse zoziziritsa ndi kutentha.
Zipinda zoyera za Class 100,000 (ISO 8) ndi ach 10,000 (ISO 7) zotsika zimatha kukhala ndi mpweya wonse kudzera mu AHU. Kuyang'ana Chithunzi 3, mpweya wobwerera ndi mpweya wakunja umasakanizika, kusefedwa, kuziziritsidwa, kutenthedwanso, ndi kunyowa musanaperekedwe ku zosefera za HEPA padenga. Pofuna kupewa kubwezeredwa kodetsedwa m'chipinda choyeretsera, mpweya wobwerera umatengedwa ndi kutsika kwa khoma. Kwa kalasi yapamwamba ya 10,000 (ISO 7) ndi zipinda zoyeretsa, mpweya umakhala wokwera kwambiri kuti mpweya wonse udutse mu AHU. Kuyang'ana Chithunzi 4, gawo laling'ono la mpweya wobwerera limatumizidwa ku AHU kuti likhazikike. Mpweya wotsalira umabwereranso ku fani yozungulira.
Njira Zina Zotengera Magawo Achikhalidwe Oyendetsa Mpweya
Zosefera za fan, zomwe zimadziwikanso kuti ma module ophatikizika a blower, ndi njira yoyeretsera pachipinda choyera yokhala ndi maubwino ena kuposa makina azikhalidwe zamakedzana. Amagwiritsidwa ntchito m'malo ang'onoang'ono ndi akulu omwe ali ndi ukhondo wocheperako monga ISO Class 3. Mitengo ya kusintha kwa mpweya ndi zofunikira zaukhondo zimatsimikizira kuchuluka kwa zosefera zomwe zimafunikira. Denga la ISO Class 8 pachipinda choyeretsera lingangofunika 5-15% yotchinga denga pomwe ISO Class 3 kapena chipinda choyeretsera chingafunikire kuphimba 60-100%.
Khwerero 9: Chitani mawerengedwe a Kutentha / Kuzizira
Mukamawerengera kutentha / kuziziritsa kwa chipinda choyeretsera, ganizirani izi:
Gwiritsani ntchito nyengo yosamala kwambiri (99.6% yotentha, 0.4% drybulb/median wetbulb cooling deign, ndi 0.4% data yamapangidwe a babubu wonyowa/wapakati).
Phatikizani kusefera mu mawerengedwe.
Phatikizani kutentha kosiyanasiyana kwa humidifier mu kuwerengera.
Phatikizani ndondomeko zowerengera.
Phatikizaninso kutentha kwa fan mu kuwerengera.
Khwerero 10: Limbikirani Malo Opangira Malo
Zipinda zoyeretsera zimakhala ndi makina komanso magetsi. Pamene ukhondo wa m'chipinda choyeretsera umakhala waukhondo, malo opangira makina ambiri amafunikira kuti apereke chithandizo chokwanira kuchipinda choyera. Pogwiritsa ntchito chimbudzi cha 1,000-sq-ft mwachitsanzo, chipinda choyeretsera cha Class 100,000 (ISO 8) chidzafunika 250 mpaka 400 sq ft malo othandizira, chipinda choyeretsa cha Class 10,000 (ISO 7) chidzafunika 250 mpaka 750 sq ft malo othandizira, Class 600000000000000000000000000000000000000 ISO 1000000000000000000000000000000000000000000 malo othandizira ISO 1,000 sq ft ya malo othandizira, ndipo chipinda choyeretsa cha Class 100 (ISO 5) chidzafunika 750 mpaka 1,500 sq ft ya malo othandizira.
Zothandizira zenizeni zenizeni zimasiyanasiyana malinga ndi kayendedwe ka mpweya wa AHU ndi zovuta (Zosavuta: fyuluta, koyilo yotenthetsera, koyilo yoziziritsa, ndi fan; Complex: chowongolera phokoso, fan fan, gawo la mpweya wothandizira, mpweya wakunja, gawo la fyuluta, gawo lotenthetsera, gawo lozizira, humidifier, fan fan, ndi discharge plenum) ndi chiwerengero cha madzi odzipatulira oyeretsera, makina opangira madzi, mpweya, mpweya, mpweya, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotentha, mpweya wotsekemera DI/RO madzi). Ndikofunikira kufotokozera zida zamakina zomwe zimafunikira malo a square footage kwa womanga polojekiti kumayambiriro kwa kamangidwe kake.
Malingaliro Omaliza
Zipinda zoyeretsa zili ngati magalimoto othamanga. Akapangidwa ndi kumangidwa bwino, amakhala makina ochita bwino kwambiri. Zikapangidwa molakwika ndi kumangidwa, zimagwira ntchito molakwika komanso zosadalirika. Zipinda zoyeretsera zili ndi ming'alu yambiri, ndipo kuyang'aniridwa ndi mainjiniya wodziwa zambiri m'chipinda choyeretsera kumalimbikitsidwa pamapulojekiti anu angapo oyamba oyeretsa.
Chitsime: gotopac
Nthawi yotumiza: Apr-14-2020
