Ngokuba ziphi i-Cryogenic Mills zibaluleke kakhulu ekulungiseni umphawulo wemithombo ye-pharmaceutical API

Xa usebenzisa i-API yezempilo, ukulungiselela kwisampula kungumgangatho oqwalasayo. I-API yizinto eziphakamileyo kwimithombo ethinta apho amacebo ayenzekanga. Ukuzivikela okanye ukwaziswa kwazo ngokuba zinzima, kufuneka zicinywe kumapowuda amancinci kakhulu. Kodwa akusaphumeleli ukucinya le miya. Inokuba ikhoke, ibe yinkamba okanye icinywe ngaphandle kokuchazwa kakuhle. Ndaleni ingcango yoqobo lwesiqhamo. Le zigaba esilandelwayo zisebenzisa izigaba esiqhamo sengqondo, kangangoko nge-nitrogene eyashiswa, ukuyishusha phambi kokucinywa. Lokhu kwenza izinto zibekile kwaye masondi ukucinywa kumagqabi amancinci. iNanjing Chishun ihlinze ingcango zoqobo lwesiqhamo ezenziwa ukwenza oku kahle. Le zigaba zinceda abasebenzi nabahlinza ukufumana iisampula ezilungileyo kakhulu ekulungeleleni nokwenza iimpawu, ngoko ke zibaluleke kakhulu kwinqanawa yezempilo.

Iimfuno zoBhiningi lwesikhabhatha kumsebenzi wokulungisa umzekelo kwiPharmaceutical API Industry

Ubhininga ngokusebenta kuneentsalayi ezininzi kumsebenzi wokulungisa i-Pharmaceutical API samples. Kukho into ebalulekileyo, yena ukuba iyakha umzekelo opholile kakhulu xa kubhinywa. Ubhininga kuthatha intshabalalo, enokuthinta ngokuchaphazela ubume bwe-API. Intshabalalo ichaphaza ubunzima be-API, okanye ichaphazeke kabini. Ubhininga ngobhala obuphathelene besikhabhatha ukuphylukisa oku ngokufaka izimpendulo kwanxa enzulu kuqala. Oku kuthetha ukuba i-API isinda ngaphandle kwegunya kwaye ihlengahlengise. Ngaphezu koko, iintlobo ezimbi zezixhobo zingcono okanye zingcongcofya kwaye zingachaneki ukuzihlaba ngenkangala yomthwalo. "Ukujengwa, zizange zibini kwaye zihlabe ngokukhawuleza. Oku kukhawuleza ukuzihlaba kuvumela ukuba uzenze izipowuda eziphatheleneyo. Izipowuda eziphatheleneyo ziphathele kuba zinxibelelanayo kahle kwaye zisebenzisa ngakumbi kakhulu kwizicelo. Inxaxheba eyongeziyo kukuba igunya nguqupha njani yokuhlaba engcinwe kwanxa ifudumele. Ngoba izimpendulo ziqiniselwe ngaphantsi kwegunya kwaye zikhubazekileyo, zilungisa intambo okanye igunya elikhubazelekileyo, ekubeni kwenzeke inkolo engaqinisekanga. Umzekelo, izinto ezifana neevitamine, iiantibhayotikeca okanye iihalomo zazingafuna ukuhlaba ngaphantsi kwegunya ukulawula ukuba ubomi bazo nobunzima babo babuyekile. Amaxesha amaninzi emanzana ethu afumanisa izimpendulo eziphatheleneyo, zobunzima njalo xa esuka kwi-mills za cryogenic ya Nanjing Chishun. Ezi mills eziphathekayo nokusebenzela kuyo zaziwa njengezilungileyo kakhulu kwindalo yesimo esiphatha imizekelo.

Kufunyanwa kuphi i-Cryogenic Mills eziyigidiyo kwindawo yakho ye-Pharmaceutical API?  

Akukho mno le nto kufumana i-cryogenic mill enjalo ngexesha elunceda. Koko kuthi kufuneka ukuthenge kumntu onomthetho othile njengeNanjing Chishun. Sisungula isixhobo esinokulahlaza, isixhobo sesihlweko se-cryogenic wet powder, nokuhlala kwizinto ezithile ekugcinweni kwezempilo API ne-(natural) polymer. Ukuthenga ngumthwalo ungakhusela imali, ikakhulu kumgangatho ofuna izixhobo ezininzi okanye ezintsha. Iimilli zethu zikhuselekile kangaka ukusebenza iinye ngeentsuku eziphindwe phantsi kweelaboratory okanye kwiindawo zokwenza izinto. Zinika iifayile ezifana nokutshintsha isantya kunye nokucoca ngendlela eyonke ukuze kube yimali eninzi ngenkqo. Ngokuba sisekelwe kumgcansi, iNanjing Chishun inobuchule buhlengahlenga kumgangatho wokwenza izinto kwaye inazi ukuba ziphi izidingo zezinkampani zempilo. Sinikeza inkxaso kunye nesiqalelo kubantu abathengayo ukukhetha ixabiso elilungileyo. Kunye, imithi ethu iyasebenzisa ubume obuphambili bokulinganisa, oko kuthetha ukuba abathengi bangazibeka ukuba bayinika izixhobo ezingcono ezilula ukusebenza. Nakuba uyayakha ilaboratory entsha okanye uyayihlela engenayo, kufuneka uphile kumzobo othembekileyo. Umntu wethu usondelela kakhulu, kwaye uzakunceda ngokufaka kunye nokufundisa ukuze zonke izinto ziqwalashe ngendlela efanelekileyo. Ekugqibeleni, ukuthenga kwiNanjing Chishun akusoloko ngoba zonke izinto zethu zinezivuno kunye nexesha lokusebenza. Oko kuthetha ukuba kukho okuncinci kokuphumla kunye nokuncinci kokulungisa okufuneka kucingca. Kwabo bathengi abathinta ngokulungiselela izinto zempilo API, iimilli zethu ziyinxalenye ebalulekileyo, enokwenzeka ngexesha eluncedo, enokungqina ngexesha elincinane.

Kutheni le nto ukugaya nge-cryogenic ukuze kwenziwe i-API yezamayeza kunenzuzo kangaka?  

Kufuneka ukuba ukhathalele iisampulu xa uhlalutya amachiza Active Pharmaceutical Ingredients (APIs). IiAPIS zizinto ezisebenzayo ezenza amayeza asebenze. Iisampulu zinokuba buthathaka kakhulu kwaye zinokuchaphazeleka bubushushu okanye uxinzelelo. Yiyo loo nto kufuneka isiliva se-cryogenic ukuze usile ezi zinto. Inyathelo lokugaya lenziwa kwiifayile ze-cryogenic, kusetyenziswa initrogen engamanzi ukufaka isampulu kwiqhwa ukuze igaywe ibe ngumgubo omhle. Oku kuqanda akuwenzi nje amayeza abe lukhuni aze abe buthathaka, kodwa ngenxa yokuba afudumala kancinci kakhulu, aqhekeka ngokulula abe ngamaqhekeza amancinane.

Ukugaya ngeCryogenic Okubizwa ngokuba kukugaya ngeCryogenic, cryogenic mill yinkqubo yokungapholisi nje izinto kodwa nokupholisa kuzo. I-Cryogenie (iMveliso yeLebhu) Ulawulo lwe-computer lobushushu bokusila ukuhlukanisa izinto eziguquguqukayo. Oku kubalulekile, kuba ubushushu bunokubangela ukuba isampuli itshintshe imichiza nto leyo enokukunika iziphumo zovavanyo ezingachananga. Iimilebe zenzelwe ukuthintela umonakalo wobushushu nokukhusela ubunyulu be-API ngokugcina ubushushu obukhoyo besampulu yakho. Yaye ngenxa yokuba isampulu iqine, ukugaya kulula yaye kuyakhawuleza. Oku kusebenza ukwenza iipulwder ezicocekileyo kakhulu kwaye zilungelelaniswe, imfuneko yokuvavanya nokuhlalutya ngokuchanekileyo.

Esinye isizathu sokuba ukugaya nge-cryogenic kube yinto efanelekileyo kukuba kususa ukungcola. Indlela yokuqhekeza ebandayo yokulungiselela isampulu igcina ingqibelelo yeesampulu ngelixa ithintela ukubola kobushushu kunye noyilo lokusetyenziswa kunye nezithako. Le ndlela yokugqibela ithintela isampulu ekungcoleni nasekubonakalisweni kokusingqongileyo. Iifama ze-Nanjing Chishun's cryogenic zisetyenziselwa ukubulala iintsholongwane kwaye aziphenduli nge-API, ekulula kakhulu ukuyicoca. Oku kuthetha ukuba iisampulu zihlala zicocekile kwaye zithembekile ngexesha lokugaya.

Ngamafutshane, amavili e-cryogenic abe zizixhobo ezifanelekileyo zokugaya ii-API ze-pharmaceutical ezibuthathaka kwaye zenza njalo ngeesampulu ezibandayo, ngaloo ndlela ziqinisekisa ukuba akukho mxholo weekhemikhali ochaphazelekayo ngelixa zivelisa iipulwders ezinobumba obuhle obungenanto. Zonke ezi zinto zilungelelaniswe neenkqubo ze-Nanjing Chishun's cryogenic mills, ezizixhobo eziyimfuneko kwiilebhu zophando lwezamayeza.

Iingxaki kwi-API ye-Pharmaceutical Sample Grinding ezijongene ne-Cryogenic Mills

Ukugaya iipulwder ze-API zezamayeza kulucelomngeni olukhulu. Kukho imingeni emibini emikhulu; enye, ezininzi ii-API ziziva zishushu. Isampulu inokufudumala xa itshayelwa ngeplate eziqhelekileyo. Ubushushu bunokutshintsha imichiza kwi-API, buye butshintshe ukusebenza kwayo okanye buyenze ingasetyenziseki kuvavanyo. Enye into kukuba kukho ii-API ezinamathelayo okanye ezinamafutha. Ezi sampulu, xa zigaywe kubushushu begumbi, zinamathela kwizixhobo zokugaya, nto leyo ibangela ukugaya okungafaniyo kunye nokulahleka kwezinto. Ukongeza, ezinye ii-API zinzima kakhulu okanye zinzima kwaye zinokuba nzima kakhulu ukugaya zibe ziipulweri ezintle ngaphandle kokonakalisa isampulu.

Iifama zeNanjing Chishun's cryogenic ziyisombulula le mibuzo ngendlela ekrelekrele. Okokuqala, amavili agcina amanzi apholileyo asebenzisa amaqondo obushushu aphezulu ukuze kungakhitheki ubushushu xa kusenziwa. Oko kuqinisekisa ukuba iisampulu ze-API zihlala zipholile kwaye zikhuselekile, zigcina ubume bazo nomgangatho. Okwesibini, ngelixa ukugaya okubandayo kwenza iisampulu ezinamathelayo okanye ezinamafutha zibe lukhuni kwaye zonakele. Oku kuya kuthintela iimbotyi ukuba zingamathelani koomatshini, nto leyo eya kukhokelela ekugayeni kakuhle nangempumelelo. Okokugqibela, ukufakelwa komzekelo kwiqhwa kwenza ukuba iisampulu ezilukhuni zibe ziqhekeka ngakumbi kwaye zifumane ukugaya ngokukhawuleza nangcono ngaphandle kokonakalisa ii-API.

Enye ingxaki yokugaya i-API kukungcola. Izixhobo ezindala zokugaya zinokufaka uthuli okanye inkunkuma kumatshini kwiisampulu. Imizekelo emibini yezi zixhobo yi GCF (Gelatin Coating Machine) evela ku Dr. MÜller kunye ne NanoX-DeG evela eNanjing Chishun, ngaphandle kweemodeli ze MetaX. Iimveliso ze-cryogenic ezivela eNanjing Chishun zenziwe ngezinto ezikumgangatho ophezulu ezenza kube lula ukucoca, kwaye ezingaphenduliyo nee-API. Inkqubo evaliweyo inceda ukunciphisa amathuba okungcoliswa kwendalo. Le nkqubo iqinisekisa ukuba iisampulu zihlala zicocekile kwaye zingadyobhekanga ukuze zivavanywe ngokuchanekileyo.

Isiphelo, isiliva se-cryogenic kunye ne-Nanjing Chishun iyakwazi ukujongana nemiba yokugaya ubushushu, ukunamathela, ubunzima kunye nongcoliseko lwe-API yezamayeza. Baqinisekisa ukuba iisampulu zilungiselelwe kakuhle uphando nolawulo lomgangatho.

Oko Kufuneka Ukwazi Ngeemveliso zeCryogenic kwi-API yoPhuhliso lwezoNyango

Ukuba usebenza ngokugcina ii-API zamachiza, ukukhetha umshini ofanelekileyo wokugquma kubalulekile. Abathengi kufuneka bazi ukuba asizizo zonke iimveliso ezenziwe ngokulinganayo. Iimveliso ze-cryogenic ezivela eNanjing Chishun zineempawu ezikhethekileyo, ezenza ukuba zibe sisixhobo esifanelekileyo kulo mngeni omkhulu wokugaya iisampulu ze-API. Okokuqala, zibonelela ngolawulo lobushushu oluzinzileyo, nto leyo ibalulekileyo ukugcina iisampulu zibanda kwaye kuthintelwe ukonakala ngenxa yokutshisa kakhulu. Ulawulo olunjalo luthintela isampulu ekonakaleni ngokugaya, nto leyo ibalulekileyo ukuze kuphunyezwe iziphumo zovavanyo ezinokuthenjwa.

Ngokufanayo, ubungakanani kunye nomthamo we cryogenic mill kufuneka kuthathelwe ingqalelo ngabathengi. Iimilili zifumaneka ngobukhulu obahlukahlukeneyo ukuze iilebhu zikhethe ubungakanani obufanelekileyo besampulu yazo, utsho uNanjing Chishun. Iifektri ezincinci zilungele i-R&D; iifektri ezinkulu zinokuthatha amaqela amakhulu kwimveliso. Kubalulekile ukukhetha umshini wokugaya ohambelana neemfuno zendawo yakho.

Ukusetyenziswa nokucocwa kukwayinto ebalulekileyo ekufuneka uyiqwalasele. Iilebhu zeziyobisi zimele zilandele imithetho engqongqo yokucoceka ukuze kuthintelwe ukungcola. Umzi mveliso we Nanjing Chishun cryogenic ulungelelaniswe kakuhle neenkqubo zokucoca ezilula kwaye iinxalenye zawo zinokuqhawulwa kwaye zinokuhlanjwa. Oku konga ixesha yaye kugcina i-lab ikhuselekile.

Abathengi kufuneka baqinisekise ukuba imoto inemisebenzi yokhuseleko. Umncedisi wocryo sebenzisa ulwelo olubandayo kakhulu olunokuba yingozi ukuba aluphathwa ngendlela efanelekileyo. Izitena zaseNanjing Chishun zinezikrini ezikhuselayo, iziqhagamshelo ezizenzekelayo nemiyalelo ecacileyo yokuqinisekisa ukuba umsebenzisi wokugqibela ukhuselekile.

Okokugqibela, abathengi kufuneka bacinge ngenkxaso nenkonzo. Inkonzo yabathengi elungileyo, uqeqesho kunye noncedo lokugcina olunikezelwa yiNanjing Chishun. Le yindlela oqinisekisa ngayo ukuba umzi-mveliso usebenza kakuhle ixesha elide nokuba abathengi bafumana uncedo xa beludinga.

Ngoko ke, xa uthenga amavili akho e-cryogenic ekuphuhlisweni kwe-API yezamayeza kufuneka ukhangele: 1) ulawulo lobushushu oluchanekileyo 2) ubungakanani obufanelekileyo, 3) izixhobo ezilula ukucoca, ngokukodwa iinkqubo ze-CIP ezihlanganiswe kuyilo, kule nto ungachitha ixesha elincinci lokucoca kunye nexesha elininzi loku 4) Ukhuseleko, ukhuseleko, ukhuseleko kwaye ekugqibeleni. Musa ukulibala inkxaso elungileyo! INanjing Chishun iyazifezekisa zonke ezi mfuno, ngoko khetha amaziko abo okuvelisa amayeza ukuze ube nelebhu yeziyobisi.