A cikin masana'antu masana'antu, kowane tsari na samarwa yana da alaƙa da amincin rayuka masu haƙuri. Daga sauyawa na kayan ruwa don tafiyar matakai, daga tsabtatawa na kayan ga ikon sarrafa muhalli na iya yiwuwar haɗarin ƙimar ƙwayoyi. Daga cikin wadannan mahaɗan hanyoyin, daPharmaceutical tsarkakakken janaretaya zama ɗaya daga cikin kayan aikin kayan aikin don tabbatar da amincin magani saboda rawar da ta ba za a iya ba da ita. Ba wai kawai yana ba da ingantacciyar tabbacin tabbataccen abu ba, amma kuma yana zama muhimmin hanyar sikelin kan masana'antu na magunguna na zamani don motsawa zuwa manyan ƙa'idodi na zamani.

Tsakanin Steam: Rayuwar Tsarin Pharmaceutical

Abubuwan da ake buƙata na tsabta a cikin samar da magunguna sun kusan stringent. Ko kuwa alloli, alamu, rigakafi, ko magunguna, kayan aiki, bututun, bututun, kwantena da hannu a cikin tsarin samarwa dole ne a cikin tsarin samar da su dole ne a cikin tsarin samar da su dole ne a cikin tsari. Tsakanin Steam (wanda aka fi sani da "Magamara sa Steam") ya zama matsakaiciyar masifa a cikin masana'antar magunguna saboda rashin nutsuwa ta magabtarwa.

Da coarfin Core da sterilization

Tsakanin Steam na iya shiga cikin sauri na ƙwayoyin cuta wanda ya rusa ƙwayoyin cuta, ƙwayoyin cuta, da kuma spores ta hanyar babban zazzabi (yawanci sama da lamba 121 ℃) da matsi mai ƙarfi. Idan aka kwatanta da masu lalata sunadarai, masu tsatstsa mai tsoka ba su da haɗari ba, musamman da ya dace don kayan aiki da kwantena waɗanda suka shigo cikin kai tsaye tare da kwayoyi. Misali, sterilization na kayan aiki kamar allurar allura suna cike layi, injunan-daskarewa-daskararru, da kuma masu fasahar bushewa sun dogara ne akan tsararren tururi.

Da tsananin ka'idodi

A cewar bukatun GMM, harhada tururi mai tsabta dole ne ya sadu da alamun uku:

Babu tushen zafi: tushen zafi shine matsanancin gurbata wanda zai iya haifar da halayen zazzabi a cikin marasa lafiya kuma dole ne a cire gaba daya cire.

Ruwan mai ba da ruwa ya sadu da matsayin: ingancin ruwa bayan tsarkakakken tsayayyen tsinkaye yana buƙatar haduwa da ruwa don allura (WFI), tare da yin ≤ 1.3 μ s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm s / cm

Kwarewar bushewar bushe: bushewar tururi ta zama ≥ 95% don kauce wa ruwa mai ruwa shafi tasirin haifuwa.

Cikakken Tsarin Aikace-aikacen aiwatarwa

Daga ster na kan layi (sip) na kayan aikin samar da kayan iska a cikin dakuna masu tsabta, daga tsaftace sturie ta hanyar lalata rayuwar pipeutcycys na samar da magancewa. Musamman ma a cikin bitar shirye-shiryen m, mai tsarkakakken janareta shine "tushen tushen iko" wanda ke gudana kusan awanni 24 a rana ba tare da katsewa ba

Batun Fasaha na Fasaha na Pharmaceutical tsarkakakken janareta

Tare da ƙara bukatar inganci, inganci, da kariya ta muhalli a cikin masana'antar harhada magunguna, fasaha mai tsayayyen ƙuri'a kuma yana ƙaruwa koyaushe. Na'urorin zamani sun sami ingantaccen tsaro da ƙarfin kuzari ta hanyar ƙirar fasaha da zamani.

Breatthrough a cikin fasahar Core

Fasahar da fasahar distillation na yawa: ta hanyar murmurewa mai yawa na kuzari, ruwa mai tsabta (galibi tsarkakewa) yana canzawa zuwa Steam mai tsabta ta sama da 30% idan aka kwatanta da kayan aikin gargajiya.

Gudanarwa na fasaha: sanye take da tsarin Kulawa ta atomatik, yanayin lokaci na ainihi, ƙararrawa ta atomatik don yanayin mahaukaci, don guje wa kurakuran mutum.

Lowaramin carbon carbon: Binciken na'urorin dawo da kayan zafi don rage sharar kuzarin kuzari, a layi tare da canji na kore na masana'antu na magunguna.

Da 'dual inshorar' tabbacin inganci

Masu tsarkakakkun masana'antu na zamani suna yawanci sanye take da hanyoyin tabbatar da daidaito na biyu:

Tsarin Kulawa na kan layi: Gaskiya Kulawa da Tsarkakakken Tsarin Stean ta hanyar shawo kan masu ƙididdigar TOC.
Tsarin zane mai sauƙi: famfo na famfo, tinkarar motsi da sauran zane-zane da sauran zane-zane suna tabbatar da raunin kayan aikin idan aka gazawa kwatsam.

Sassauci a cikin amsa ga hadaddun bukatun

Za a iya tsara masu samar da kayan ƙira na mai tsinkaye don filayen da ke fitowa kamar su Biopharmaipceuticals da ƙwayar tantanin halitta. Misali, kayan aikin da aka yi amfani da su don samar da alurar rigakafin Mrna na bukatar haduwa da manyan bukatun bakararre, kuma wasu kamfanoni sun gabatar da matakin Elepoxin a cikin ruwa mai ɗaure a ƙasa 0.001 EU / ML.
Tare da ci gaban cigaban bipharmaiticals, an gabatar da bukatun mafi girma don ingancin tsayayyen tururi. Samun sababbin magunguna kamar magungunan kayan gungu da kayan aikin monochlonal suna buƙatar ƙimar yanayin tururi mai ƙira. Wannan ya gabatar da wani sabon kalubale na fasaha don masu samar da masu korafi.

Manufar samar da kore tana canza tsarin zance na masu samar da masu gidan tururi. Aikace-aikacen kayan aiki na samar da makamashi, kayan m yanayin muhalli duk suna da masana'antar zuwa ga hanya mai ɗorewa.

Aikace-aikacen fasaha na fasaha yana sake sauya yanayin aikin masu tsinkayen tururi. Aiwatar da Kulawa mai kyau, Gwajin Gwaji, Gyara mai hankali da sauran ayyuka ba kawai inganta ingancin ayyukan ba, har ma yana samar da ƙarin tabbacin ingancin miyagun ƙwayoyi.

A yau, kamar yadda amincin magani yana ƙara ƙima, mahimmancinPharmaceutical tsarkakakken masu samar da tururiyana kara zama sananne. Ba wai kawai kayan aiki ne masu mahimmanci don samar da magani ba, amma kuma wani muhimmin shinge don tabbatar da amincin mu na jama'a. Tare da ci gaba na ci gaba na fasaha, tsarkakakken masana'antar tururi zai taka rawar gani a masana'antar magunguna kuma a samar da babbar gudummawa ga lafiyar ɗan adam.