Ulayini wokukhiqiza othomathikhi ogcwele we-polypropylene (PP) isisombululo sebhodlela le-intravenous (IV): ukuqanjwa kabusha kwezobuchwepheshe kanye nombono wezimboni

Emkhakheni wokufakwa kwezokwelapha, amabhodlela e-polypropylene (PP) asephenduke ifomu elijwayelekile lokupakisha lezixazululo ze-intravenous infusion (IV) ngenxa yokuzinza kwawo okuhle kakhulu kwamakhemikhali, ukumelana nokushisa okuphezulu, nokuphepha kwezinto eziphilayo. Ngokukhula kwesidingo sezokwelapha emhlabeni wonke kanye nokuthuthukiswa kwamazinga emboni yezemithi, imigqa yokukhiqiza isisombululo se-PP bottle IV ezenzakalelayo kancane kancane iba indinganiso embonini. Le ndatshana izokwethula ngokuhlelekile ukwakheka kwemishini ewumongo, izinzuzo zobuchwepheshe, namathemba emakethe omugqa wokukhiqiza we-PP bottle IV.

Imishini eyinhloko yomugqa wokukhiqiza: ukuhlanganiswa kwe-modular nokusebenzisana okunembayo okuphezulu

IsimanjeUmugqa wokukhiqiza wesixazululo se-PP ibhodlela IViqukethe izinto ezintathu ezibalulekile: umshini womjovo we-preform/hanger, umshini wokubumba i- blow, nokuhlanza, ukugcwalisa kanye nomshini wokuvala. Yonke le nqubo ixhunywe ngaphandle komthungo ngohlelo lokulawula oluhlakaniphile.

1. Umshini womjovo wangaphambili wokubumba/we-hanger: ukubeka isisekelo sobuchwepheshe bokubumba obunembayo

Njengendawo yokuqala yomugqa wokukhiqiza, umshini wokubumba wangaphambili usebenzisa ubuchwepheshe bomjovo wengcindezi ephezulu ukuze uncibilike futhi wenze ipulasitiki izinhlayiya ze-PP emazingeni okushisa aphezulu angama-180-220 ℃, futhi uwajove ezimbotsheni zamabhodlela ngokusebenzisa isikhunta esinembe kakhulu. Isizukulwane esisha semishini sifakwe uhlelo lwe-servo motor drive, olungafinyeza umjikelezo wokubumba ube imizuzwana engu-6-8 futhi ulawule iphutha lesisindo sebhodlela elingenalutho ngaphakathi ± 0.1g. Idizayini yesitayela se-hanger ingaqedela ngokuhambisanayo ukubunjwa kwendandatho yokuphakamisa umlomo webhodlela, ixhumeke ngqo kunqubo yokuphephetha elandelayo, igweme ubungozi bokuphatha ukungcola okwesibili ezinqubweni zendabuko.

2. Umshini wokufutha ibhodlela ozenzakalelayo ngokugcwele: ukusebenza kahle, ukonga amandla kanye nokuqinisekiswa kwekhwalithi

Umshini wokufutha ibhodlela usebenzisa ubuchwepheshe bokubumba obuyisinyathelo esisodwa (ISBM). Ngaphansi kwesenzo se-biaxial directional stretching, ibhodlela elingenalutho liyashiswa, linwetshwe, futhi libunjwe phakathi kwemizuzwana engu-10-12. Imishini ifakwe isistimu yokulawula izinga lokushisa le-infrared ukuze kuqinisekiswe ukuthi iphutha lokufana kokuqina lomzimba webhodlela lingaphansi kuka-5%, futhi ingcindezi yokuqhuma ingaphezu kuka-1.2MPa. Ngobuchwepheshe bokulawula ukucindezela kwe-loop evaliwe, ukusetshenziswa kwamandla kuncishiswa ngo-30% uma kuqhathaniswa nemishini yendabuko, kuyilapho kuzuza ukukhishwa okuzinzile kwamabhodlela angu-2000-2500 ngehora.

3. Okuthathu kokukodwa komshini wokuhlanza, wokugcwalisa nokuvala: umnyombo wokukhiqizwa kwe-aseptic

Le divayisi ihlanganisa amamojula amathathu amakhulu asebenzayo: ukuhlanzwa kwe-ultrasonic, ukugcwaliswa okulinganiselwe, kanye nokuvalwa kwe-hot melt.

Iyunithi yokuhlanza: Ukwamukela uhlelo lwe-multi-stage reverse osmosis lokujikeleza kwamanzi, kuhlanganiswe nokuhlunga kwe-terminal ye-0.22 μ m, ukuqinisekisa ukuthi amanzi okuhlanza ahlangabezana ne-pharmacopoeia WFI standard.

Iyunithi yokugcwalisa: ifakwe imitha yokugeleza kwekhwalithi kanye nesistimu yokumisa ebonakalayo, ngokunemba kokugcwalisa kwe-± 1ml kanye nesivinini sokugcwalisa esingafika kumabhodlela we-120 / iminithi.

Iyunithi yokuvala: kusetshenziswa ukutholwa kwe-laser nobuchwepheshe bokuvalwa komoya oshisayo, izinga lokufaneleka lokuvala lidlula u-99.9%, futhi amandla okuvala makhulu kuno-15N/mm ².

Izinzuzo zomugqa wonke wobuchwepheshe: impumelelo kubuhlakani kanye nokusimama

1. Uhlelo olugcwele lokuqinisekisa oyinyumba

Ulayini wokukhiqiza uklanywe ngokulawulwa kwemvelo kwegumbi elihlanzekile (i-ISO level 8), ukuhlukaniswa kwe-laminar flow hood, kanye nokupholishwa kwe-electrolytic ebusweni bemishini, kuhlanganiswe ne-CIP/SIP yokuhlanza ku-inthanethi kanye nohlelo lokuvala inzalo, ukuze kuhlangatshezwane nezidingo zokuhlanzeka kwezinga le-GMP ashukumisayo kanye nokunciphisa ubungozi bokungcoliswa kwamagciwane angaphezu kwama-90%.

2. Ukuphathwa kokukhiqiza okuhlakaniphile

Ifakwe uhlelo lokukhishwa kokukhiqizwa kwe-MES, ukuqapha ngesikhathi sangempela okokusebenza kwe-OEE (ukusebenza kahle kwemishini), isexwayiso sokuchezuka kwepharamitha yenqubo, kanye nokwenza kahle kwejubane lokukhiqiza ngokuhlaziywa kwedatha enkulu. Izinga lokuzenzakalela kwawo wonke ulayini selifinyelele ku-95%, futhi inani lamaphuzu okungenelela ngesandla lehlisiwe laba ngaphansi kuka-3.

3. Ukuguqulwa kokukhiqiza okuluhlaza

Ukuphinda kusetshenziswe kabusha okungu-100% kwezinto ze-PP kuhambisana nezimo zemvelo. Ulayini wokukhiqiza wehlisa ukusetshenziswa kwamandla ngo-15% ngokusebenzisa amadivaysi okubuyisela ukushisa okulahlwayo, futhi uhlelo lokugaywa kabusha kwemfucuza lukhuphula izinga lokugaywa kabusha kwezilahliwe libe ngu-80%. Uma kuqhathaniswa namabhodlela engilazi, izinga lokulimala kwezokuthutha lamabhodlela e-PP lehle lisuka ku-2% laya ku-0.1%, kanti i-carbon footprint yehliswe ngo-40%.

Amathemba emakethe: ukukhula okukabili okuqhutshwa ukufunwa kanye nokuphindaphinda kwezobuchwepheshe

1. Amathuba okukhula kwezimakethe zomhlaba

Ngokusho kweGrand View Research, imakethe yokufaka i-intravenous yomhlaba wonke kulindeleke ukuthi inwebe ngesilinganiso sokukhula esihlanganisiwe sonyaka esingu-6.2% ukusuka ngo-2023 kuya ku-2030, kanti usayizi wemakethe yebhodlela lokufakwa kwe-PP odlula ama-dollar ayizigidi eziyizinkulungwane ezingama-4.7 ngo-2023.

2. Isiqondiso sokuthuthukisa ubuchwepheshe

Ukukhiqizwa okuguquguqukayo: Dala uhlelo lokushintsha isikhunta ngokushesha ukuze ufinyelele isikhathi sokushintsha esingaphansi kwemizuzu engama-30 ngezinhlobo zamabhodlela acacisiwe amaningi ukusuka ku-125ml kuye ku-1000ml.
Ukuthuthukiswa kwedijithali: Kwethulwa ubuchwepheshe obungamawele edijithali ukuze kulungiswe iphutha, kunciphisa umjikelezo wokulethwa kwemishini ngo-20%.

Ukuqamba izinto ezintsha: Thuthukisa izinto ze-copolymer PP ezimelana nokuvalwa inzalo kwe-gamma ray futhi andise ukusetshenziswa kwazo emkhakheni we-biologics.

Iumugqa wokukhiqiza ozenzakalelayo ngokuphelele wesixazululo sebhodlela IV se-PPilungisa kabusha isimo semboni yokupakisha ngokufakwa emthanjeni ngokuhlanganiswa okujulile kwedizayini yemojuli, ukulawula okuhlakaniphile, nobuchwepheshe bokukhiqiza obuluhlaza. Ngesidingo se-homogenization yomhlaba wonke yezinsiza zezokwelapha, lo mugqa wokukhiqiza ohlanganisa ukusebenza kahle, ukuphepha, nokuvikelwa kwemvelo uzoqhubeka nokudala inani lemboni futhi ube yisixazululo sokulinganisa sokuthuthukisa imishini yemithi.


Isikhathi sokuthumela: Feb-13-2025

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