Ngatitsanangure zvinorehwa neSF1 kusvika kuSF6 kubva pamaonero einjiniya.
Chekutanga, ASME BPE standard (BioProcessing Equipment) inoshandisa mazita aya kupatsanura zvikamu zvichienderana nekushandiswa kwazvinoda munzira yemvura uye huwandu hwevimbiso yemhando uye magwaro anopiwa nemugadziri.
Hazvisi zvinhu zvakagadziriswa. Chigadziko chesimbi chisina ngura che316L chinogona kugadzirwa kuti chishandeSF1, SF3, kana SF5 level.Musiyano uri pakuti yakagadzirwa sei, yakaongororwa sei, uye yakanyorwa sei.
SF1 - Giredhi reMabhizinesi / reMaindasitiri
· Chokwadi: Izvi zvinoshandiswa nemachubhu, mapaipi, uye zvekuisa zvinhu. Hazvina zvitupa zvakakosha uye hazvina kuitirwa kushandiswa zvakananga mukubata chigadzirwa munzvimbo ine biopharma inodzorwa.
· Nguva Yokushandisa: Kune tambo dzemagetsi dzisingabatanidzwe nechigadzirwa (semuenzaniso, utsi hwemiti, mvura inotonhorera, mafuremu ekutsigira mweya wemidziyo). Kushandisa SF1 muchigadzirwa kana CIP/SIP (Clean-in-Place / Steam-in-Place) mutsetse injodzi huru yekutevedzera mitemo.
SF2 - Yakapedzwa Zvishoma
· Chokwadi: Iri iboka risingawanzo shandiswa. Zvikamu zvinogadzirwa nezvinhu zvisina kugadzirwa zvinosangana nezvinodiwa neBPE chemistry, asi chigadzirwa chekupedzisira hachina chitupa chakazara. Funga nezvazvo sedanho riri pamusoro peSF1 asi harina kunyatso shandiswa.
· Nguva Yokushandisa: Inzvimbo isina kuchena. Inowanzo dzivirirwa kune masisitimu akakosha. Inogona kuwanikwa mune mamwe masisitimu ekutsigira asiri akakosha uko kuchena kwezvinhu kusiri nyaya diki asi chitupa chakazara cheBPE hachina kururama.
SF3 - Chigadzirwa cheBPE chakajairika
· Chokwadi: Iri ndiro basa guru reindasitiri yekugadzira zvinhu zvipenyu. Kana dhirowa richida "BPE fitting," inenge nguva dzose inofungidzirwa kuti SF3. Iri ndiro giredhi rinogamuchirwa kune chero chigadzirwa kana CIP/SIP system.
· Nguva Yokushandisa: Kwese kwese munzira yechigadzirwa. Zvishandiso zvinovirisa, zvinogadzira zvinhu zvipenyu, zvinodzivirira chromatography, matangi ekubata, uye mapaipi ese anoenderana nechigadzirwa, buffer, uye CIP/SIP fluids.
SF4 - Chigadzirwa cheBPE cheHigh-Pressure
· Chokwadi: Iyi iSF3 inoongororwa kuti iwane kirasi ine kumanikidzwa kwakanyanya. Zvese zvinodiwa zvemhando yepamusoro uye magwaro eSF3 zvinoshanda.
Nguva Yokushandisa: Mumasystem ane kumanikidzwa kwakanyanya, akadai seaya anowanikwa mune mamwe ma skid ekusefa, chromatography ine kumanikidzwa kwakanyanya, kana chero application apo kumanikidzwa kwedhizaini kunopfuura chiyero chakajairwa chezvikamu zveSF3.
SF5 - Kuongorora Kugamuchira Kugadziriswa Kwezvinhu Zvakasiyana-siyana
· Chokwadi: Ichi chikamu cheSF3 chakaongororwa uye chagamuchirwa nemushandisi wekupedzisira (iwe, kambani ye biopharma) wega wega. Mugadziri anopa chikamu chacho nezvitupa zvacho, asi iwe unoita ongororo yako yekuwedzera uye yakasimba.
· Nguva Yokushandisa: Kune mashandisirwo akakosha zvikuru apo kukundikana hakusi sarudzo (semuenzaniso, mitsara yekupedzisira yekugadzira chigadzirwa, mitsara yekuzadza). Izvi zvinowedzera mutengo wakakosha nenguva asi zvinopa chivimbo chepamusoro muhunhu hwechikamu.
SF6 - Mutengesi Akapihwa Chitupa uye Akapihwa Chitupa
· Chokwadi: Ichi chitupa che "black box". Uri kuvimba nemugadziri wezvikamu (mutengesi) kuti aite ongororo yakasimba sezvawaizoita paSF5. Mutengesi anopa chitupa chinoratidza kuti chikamu ichi chinosangana nezvinodiwa zvese zveSF5.
· Nguva Yokushandisa: Kana uchida vimbiso yemhando yepamusoro yeSF5 asi usina kugona kwekuongorora mukati mekambani kana kuti uchida kugadzirisa nyaya dzekutengesa. Zvinoda kuvimba kwakanyanya uye Chibvumirano cheHunhu chakasimba nemutengesi.
Nekunzwisisa zvikamu izvi, unogona kuita sarudzo dzakarongeka, dzinoshanda, uye dzinotevedzera mitemo yemagadzirirwo ehurongwa hwako hwekugadzira zvinhu zvipenyu.
Nguva yekutumira: Mbudzi-18-2025