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Smart Weigh ya himmatu wajen taimaka wa abokan ciniki su kara yawan aiki a rahusa.
Marubuci: Smartweigh-Multihead Weighter
Zaɓuɓɓukan fakitin aseptic guda huɗu don yin la'akari. A yau, fasahohi daban-daban da ke yin niyya ga masana'antun magunguna da na biopharmaceutical sune: (1) cikakken aji 100 masu tsabta, (2) masu keɓewa, (3) tsare-tsaren shingen shiga (RABS), (4) tsarin amfani guda ɗaya. Wanne ya fi maka? 1. Tsabtace aji na 100: Fasahar ɗaki an samo asali ne a cikin 1960s don amfani da shi a cikin masana'antar sararin samaniya da na'urorin lantarki don guje wa gurɓatar ƙananan sassa.
Kwayoyin cuta barbashi ne, kuma nan da nan masana'antun harhada magunguna sun gane cewa wannan fasaha na iya ba da tabbacin iskar bakararre. aleksandarlittlewolf - www.freepik.comPharma-gowning-matasan-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Class 100 dakunan tsabta sun fi kowa a masana'antar aseptic (ISO 5 da A/B aikin aji daidai yake), ta yin amfani da matatar iska mai inganci (HEPA) don cire duk wani abu da ƙwayoyin cuta. Babban ƙarar laminar ko iska ta unidirectional yana rage canja wurin barbashi daga wuri ɗaya zuwa wani.
A cikin 1970s, an cika cika aseptic akan injunan ƙayyadaddun ƙayyadaddun abubuwan tace HEPA. Sassan na'ura da ke sama da kwantena suna da yuwuwar kamuwa da cuta, kuma bayan lokaci ana motsa su gwargwadon yuwuwar ƙasa da matakin aiki. Don mafi kyawun maida iskar da aka tace akan injin, an kuma ƙara murfin taga filastik.
Tufafin taga kuma yana tunatar da mai aiki don guje wa taɓa na'ura ko samfur. Masu sana'a sun juya zuwa 100% HEPA rufi don sarrafa dukan dakuna zuwa aji 100. Wannan yana inganta sarrafawa, amma yana ƙara yawan kuɗi da farashin aiki, musamman tsarin sarrafa iska.
2. Opto-Isolators: A cikin 80s da 90s, an haɓaka masu keɓancewa don inganta shinge tsakanin mutane da kayayyaki yayin rage farashi. An kwatanta mai keɓewa a matsayin ɗaki mai tsabta a cikin akwati. An rufe gaba dayan tsarin a cikin ma'ajin da aka rufe, ana matse shi da iska ta tace ta masu tace HEPA.
Yayin aiki, babu wani ma'aikaci da aka yarda ya shiga sai ta hanyar haɗin safar hannu. Hoton chase-logeman anchaselogeman-isolator-web.jpg don tsarin keɓewa (ba a nuna matatar HEPA na sama ba). Hoto na chase-logeman anchase-logman-isolator-inside-web.jpg yana ciyar da keɓaɓɓen ciki yana nuna tashar safar hannu.
Bayan aikin samarwa, za a buɗe mai keɓewa, tsaftacewa, kuma a shirye don gudu na gaba. Da zarar an sake rufe shi, mai keɓe yana cike da sterilant, yawanci tururi hydrogen peroxide (VHP), don bakara duk abin da ke ciki. Ba kamar feshi na gargajiya ko goge goge ba, VHP yana shiga cikin mafi ƙanƙantar ɓarna.
Da zarar an haifuwa, kowane saitin ƙarshe ana yin shi ta tashar safar hannu. A ka'ida, ya kamata a yi aiki da mai keɓewa a cikin sararin da ba a sarrafa shi, kamar sito, ta ma'aikacin sanye da rigar lab. A ka'ida shi ne.
A zahiri, kamfanoni da yawa sun shigar da masu keɓancewa a cikin ɗakunan tsabta na aji 100. Wannan yana ba da ƙarin tsaftacewa, amma ƙimar ita ce haɓaka mai keɓancewa don gujewa. 3. Restricted Access Barrier System (RABS): RABS yarjejeniya ce tsakanin tsarin budewa da keɓantaccen tsarin, RABS ya ƙunshi tsari a cikin ƙaƙƙarfan shinge.
Ayyukan aiki suna shiga ta tashar safar hannu. Fasahar Syntegon Pharma Syntegon-Pharma- Products_filling and Closing_FXS_3100-web.jpg Buɗewar RABS ta miƙe har zuwa rufi, ta dogara da tsarin sarrafa iska da tacewa ɗakin. Rufe RABS ya ƙunshi tsarin sarrafa iska da tsarin tacewa.
RABS yana da fa'idodin farashi mai mahimmanci akan masu keɓancewa saboda sauƙin sa. Wannan gaskiya ne musamman idan ana iya kasancewa a cikin ɗakunan tsaftar da ke akwai sannan kuma a rage farashin gini. Bukatar gina ɗaki mai tsabta yana daidaita wasu kudaden ajiyar kuɗi idan aka kwatanta da masu keɓewa.
4. Tsarin da za a iya zubarwa: Tsarin sarrafa kayan da za a iya zubarwa yana ƙara karuwa a aikace-aikacen aseptic. Waɗannan tsarin sun ƙunshi jakar filastik don maye gurbin gwangwanin ƙarfe na gargajiya. Jakar ta zo an riga an shirya ta tare da komai na tacewa, tubing, tashar jiragen ruwa, nozzles mai cikawa, da sauran kayan haɗin da ake buƙata.
An rufe shi a cikin jakar kariya kuma an haifuwa. Na'urar masana'anta ta kammala bakararrewar tsarin kuma tana shirye don aiki. Hoton sartorioussaritus Img_OctoPlus-_4154-web.jpg Wasu masana'antun suna ba da tsarin amfani guda ɗaya na al'ada, gami da Sartorius (Pre-VAS - wanda aka riga aka rigaya, an riga an haɗa shi, wanda aka rigaya - Project Syntegon), Kamfanin Pall (Biotech ɗin sa sau ɗaya Amfani da Jima'i). Tsarin) da sauransu.
A cewar Marion Monstier, Sartorius Freeze-Thaw Products Manager, fa'idodin tsarin amfani guda ɗaya sun haɗa da: • Rufe tsarin yana rage canja wurin samfur da sarrafawa, rage haɗarin gurɓatawa. • Maye gurbin tsarin amfani guda ɗaya tsakanin tafiyar samfur yana kawar da yuwuwar gurɓatawa saboda rashin cikawa ko tsaftacewa mara dacewa. • Idan aka kwatanta da tsarin sake amfani da su, waɗannan madadin tsarin suna rage canji da lokacin saiti.
• Suna kawar da buƙatun tabbatar da tsaftacewa. • Suna magudana mafi kyau, ta haka suna ƙara dawo da samfur.
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