Ukubonisana Kwezinto Eziphilayo Nokuklama Nokuthuthukiswa

Ama-Biomaterials izinto zemvelo noma ezenziwe umuntu, ezihlanganisa yonke noma ingxenye yesakhiwo esiphilayo noma idivayisi ye-biomedical eyenza, ikhulise, noma imiselele umsebenzi wemvelo. Ama-Biomaterials asetshenziswa kwezokwelapha izicelo zamazinyo, ukuhlinzwa, kanye nokulethwa kwezidakamizwa (isakhiwo esinemikhiqizo yemithi ekhulelwe singafakwa emzimbeni, okuvumela ukukhishwa isikhathi eside komuthi esikhathini eside). Ama-Biomaterials angase abe nomsebenzi omuhle, njengokusetshenziselwa i-valve yenhliziyo, noma angase abe ne-bioactive ngokusebenza okusebenzisanayo okufana nezimila ze-hip ezimbozwe nge-hydroxy-apatite. Ama-biomaterials angase abe izinto ezenziwe umuntu ezakhiwe ngezinsimbi, izitsha zobumba, noma zibe ama-autografts, ama-allografts noma ama-xenografts asetshenziswa njengezinto zokufakelwa.

I-biomatadium isetshenziswa kabanzi ku:

• Usimende wethambo

• Amapuleti amathambo

• Ukushintshwa okuhlangene

• Imisipha yokwenziwa kanye nemisipha

• Izitho zokufakelwa zemithambo yegazi

• Ama-valve enhliziyo

• Imishini yokulungisa isikhumba

• Izimila zamazinyo

• Ukushintshwa kwe-cochlear

• Ama-contact lens

• Ukufakelwa kwebele

• Amanye ama-implants omzimba

Ukuhambisana kwe-Biomaterials (i-biocompatibility) nomzimba kufanele kuxazululwe futhi kuqinisekiswe ngaphambi kokuba umkhiqizo ubekwe emakethe futhi usetshenziswe esimweni somtholampilo. Ngenxa yalokhu, ama-biomatadium ngokuvamile angaphansi kwezidingo ezifanayo zalezo ezitholwa yimithi yokwelapha emisha. I-Biocompatibility ihlobene nokuziphatha kwama-biomaterials ezindaweni ezihlukahlukene ngaphansi kwezimo ezihlukahlukene zamakhemikhali nezomzimba. I-Biocompatibility ingase ibhekisele ezimpahleni ezithile zento ethile ngaphandle kokucacisa ukuthi impahla izosetshenziswa kuphi noma kanjani. Isibonelo, into ethile ingase ivuse ukusabela okuncane noma kungabi nhlobo kwamasosha omzimba entweni ethile, futhi ingase ingakwazi noma ingakwazi ukuhlangana nohlobo oluthile lweseli noma izicubu). Imishini yezokwelapha yesimanje kanye nama-prostheses ngokuvamile enziwa ngezinto ezihlukahlukene ezihlukahlukene, ngakho-ke kungase kungenzeki ngaso sonke isikhathi ukukhuluma nge-biocompatibility yento ethile.

Ngaphezu kwalokho, into ethile akufanele ibe nobuthi ngaphandle uma iklanywe ngokukhethekile ukuze ibe njengezinhlelo ezihlakaniphile zokulethwa kwezidakamizwa eziqondise amangqamuzana omdlavuza ukuze awabhubhise. Ukuqonda i-anatomy kanye ne-physiology yendawo yesenzo kubalulekile ukuze i-biomaterial isebenze kahle. Isici esingeziwe siwukuncika kumasayithi athile e-anatomical okufakelwa. Ngakho-ke kubalulekile, ngesikhathi somklamo we-biomaterials, ukuqinisekisa ukuthi okokusebenza kuzolingana ngokuhambisanayo futhi kube nomphumela onenzuzo endaweni ethile ye-anatomical yokusebenza.

IZINKONZO ZETHU

Sinikezela ngedizayini ye-biomaterials, ukuthuthukiswa, ukuhlaziya kanye nezinsizakalo zokuhlola ezisekela intuthuko kanye nokugunyazwa kwemakethe kwamadivayisi ezokwelapha nezinhlanganisela zedivayisi yezidakamizwa, ukubonisana, ufakazi ochwepheshe kanye nezinsizakalo zamacala.

UKWENZIWA NOKUTHUTHUKISWA KWE-BIOMATERIALS

Onjiniyela bethu bokuklama nokuthuthuka kwe-biomatadium nososayensi banobuchwepheshe bokuklama nokukhiqiza ama-biomaterials kubakhiqizi abakhulu be-IVD abanemiphumela efakazelwe yamakhithi okuxilonga. Izicubu zebhayoloji zihlelwe ngaphakathi ezikalini eziningi, zenza imisebenzi eminingi yesakhiwo neyomzimba. Ama-biomaterials asetshenziselwa ukufaka esikhundleni sezicubu zebhayoloji ngakho-ke kufanele aklanywe ngendlela efanayo. Ochwepheshe bethu bezifundo banolwazi nolwazi ezingxenyeni eziningi zesayensi zalezi zinto eziyinkimbinkimbi kanye nezinhlelo zokusebenza ezihlanganisa i-biology, physiology, mechanics, simulation izinombolo, chemistry ngokomzimba... njll. Ubudlelwano babo obuseduze nolwazi lwabo ngocwaningo lwezokwelapha kanye nokufinyelela okulula kuzindlela eziningi zokulingisa abalingisi nezindlela zokuzibona ngeso lengqondo kuyimpahla yethu ebalulekile.

Indawo eyodwa enkulu yokuklama, "I-Biointerfaces" ibalulekile ekulawuleni impendulo yeseli kuma-biomaterials. Izici ze-biochemical kanye ne-physico-chemical of biointerfaces zilawula ukunamathela kwamaseli kuzinto eziphilayo kanye nokuthathwa kwama-nanoparticles. Amabhulashi e-polymer, amaketanga e-polymer anamathiselwe ekugcineni kwesinye kuphela i-substrate engaphansi ayizimbotshana zokulawula izixhumi-moya ezinjalo. Lezi zimbobo zivumela ukuhlanganisa izici ze-physico-chemical of biointerfaces ngokulawula ukushuba kwazo, ukuminyana kweketango kanye nekhemistri yamayunithi azo ahlanganisayo futhi angasetshenziswa ezinsimbi, izitsha zobumba namapholima. Ngamanye amazwi, zivumela ukucushwa kwezakhiwo ze-bioactive zohlu olubanzi lwezinto zokwakha, kungakhathaliseki ukuthi zingakanani kanye namakhemikhali angaphezulu. Onjiniyela bethu be-biomaterial bafunde ukunamathela kwamaprotheni kanye nokusebenzisana namabhulashi e-polymer, baphenya izici ze-biofunctional zama-biomolecules ahlanganiswe namabhulashi e-polymer. Ucwaningo lwabo olujulile lube wusizo ekwakhiweni kwezingubo zokufakela izimila, izinhlelo zesiko lamaseli e-vitro kanye nokwakhiwa kwama-vector okulethwa kwezakhi zofuzo.

I-geometry elawulwayo iyisici esingokwemvelo sezicubu nezitho ku-vivo. Ukwakheka kwejiyomethri kwamaseli nezicubu ezikalini zobude obuningi kubalulekile endimeni yabo nasekusebenzeni kwabo, kanye nophawu lwezifo ezinjengomdlavuza. I-In vitro, lapho amaseli eyisiko ezitsheni zepulasitiki zokuhlola, lokhu kulawulwa kwejiyomethri kuvamise ukulahleka. Ukwakha kabusha nokulawula ezinye izici zejiyomethri zezinhlelo zebhayoloji ku-vitro kubalulekile ekuthuthukisweni kwezikafula zobunjiniyela bezicubu kanye nokuklanywa kokuhlolwa okusekelwe kumaseli. Izovumela ukulawulwa okungcono kwe-phenotype yeseli, isakhiwo sezinga eliphezulu kanye nomsebenzi, okubalulekile ekulungiseni izicubu. Lokhu kuzovumela ukulinganisa okunembe kakhudlwana kweseli nokuziphatha kwe-organoid in vitro kanye nokunqunywa kokusebenza ngempumelelo kwezidakamizwa nokwelashwa. Onjiniyela bethu be-biomaterials bathuthukise ukusetshenziswa kwamathuluzi okwenza iphethini ezikalini ezihlukene zobude. Lezi zindlela zokwenza amaphethini kufanele zihambisane ngokugcwele nekhemistri ye-biomaterials lapho lezi zinkundla zisekelwe khona, kanye nezimo ezifanele zesiko lamaseli.

Kunezinye izinkinga eziningi zokuklama nentuthuko onjiniyela bethu be-biomaterials abaye basebenza kuzo kuyo yonke imisebenzi yabo. Uma ungathanda ulwazi oluthile mayelana nomkhiqizo othile sicela usithinte.

IZINKONZO ZOKUHLOLA I-BIOMATERIALS

Ukuze udizayine, uthuthukise futhi wenze imikhiqizo ye-biomaterial ephephile nesebenzayo, kuyilapho uhlangabezana nezimfuneko ezingokomthetho zokugunyazwa ukumaketha, ukuhlolwa kwaselabhorethri okuqinile kuyadingeka ukuze kuqondwe izici ezihlobene nokuphepha komkhiqizo, njengokuthambekela kwemikhiqizo ye-biomaterial yokukhipha izinto ezivuzayo, noma ukusebenza. Imibandela, efana nezakhiwo zemishini. Sikwazi ukufinyelela izinhlobonhlobo zamakhono okuhlaziya ukuze siqonde ubunikazi, ubumsulwa, kanye ne-biosafety yenani elikhulayo lezinto eziphilayo ezisetshenziswa emikhiqizweni yezokwelapha ngokusebenzisa umzimba, amakhemikhali. , mechanical, and microbiological testing methodologies. Njengengxenye yomsebenzi wethu sisiza abakhiqizi ukuthi bahlole ukuphepha kwamadivayisi aqediwe ngokusekela ukubonisana ngezinto ezinobuthi. Sihlinzeka ngezinsizakalo zokuhlaziya ukusekela ukuthuthukiswa komkhiqizo kanye nokulawulwa kwekhwalithi yezinto ezingavuthiwe nemikhiqizo eqediwe. Sinolwazi ngezinhlobo eziningi zezinto eziphilayo ezifana noketshezi, amajeli, ama-polymers, izinsimbi, izitsha zobumba, i-hydroxyapatite, izinhlanganisela, kanye nezinto ezitholakala ngokwebhayoloji njenge-collagen, i-chitosan, i-peptide matrices, nama-alginates. Ezinye izivivinyo ezinkulu esingazenza yilezi:

• Ukucaciswa kwamakhemikhali nokuhlaziya okuyisisekelo kwama-biomaterials ukuze kuzuzwe ukuqonda okuphelele komkhiqizo ukuze uhanjiswe ngokulawula kanye nokuhlonza noma ukulinganisa ukungcola noma imikhiqizo eyonakalisayo. Siyakwazi ukufinyelela kumalebhu ahlome ngamasu anhlobonhlobo okunquma ukwakheka kwamakhemikhali, njengokuhlaziywa kwe-infrared spectroscopy (FTIR, ATR-FTIR), i-nuclear magnetic resonance (NMR), i-size exclusion chromatography (SEC) kanye ne-plasma ehlanganiswe nge-inductively-coupled. i-spectroscopy (ICP) ukuhlonza nokukala ukwakheka nokulandelela izakhi. Ulwazi oluyisisekelo mayelana nendawo ye-biomaterial itholwa yi-SEM / EDX, kanye nempahla eyinqwaba nge-ICP. Lawa masu angaphinde agqamise ukuba khona kwezinsimbi ezingaba nobuthi ezifana nomthofu, i-mercury ne-arsenic ngaphakathi nasezintweni eziphilayo.

• Ukubonakala kwezinhlamvu zokungcola kusetshenziswa ukuhlukaniswa kwesilinganiso selabhorethri kanye nohlu lwe-chromatography noma izindlela ze-mass spectrometry ezifana ne-MALDI-MS, LC-MSMS, HPLC, SDS-PAGE, IR, NMR kanye ne-fluorescence...njll.

• Ukuhlaziywa kwe-polymer ye-Biomaterial ukuze kubonakale ubuningi bezinto ze-polymer kanye nokuthola izinhlobo ezingeziwe ezifana nama-plasticizers, ama-colorants, ama-anti-oxidant nama-filler, ukungcola okufana nama-monomers angaphenduliwe nama-oligomers.

• Ukunqunywa kwezinhlobo zezinto eziphilayo ezithakaselwayo njenge-DNA, i-Glycoaminoglycans, okuqukethwe okuphelele kwamaprotheni...njll.

• Ukuhlaziywa kokusebenza okufakwe kuma-biomaterials. Senza izifundo zokuhlaziya ukuze sichaze ukukhishwa okulawulwayo kwala mamolekyuli asebenzayo njengama-antibiotic, ama-antimicrobials, ama-polymer okwenziwa kanye nezinhlobo ze-inorganic ezivela kuma-biomaterials.

• Senza izifundo zokuhlonza kanye nenani lezinto ezikhiphekayo nezivulekayo ezivela ku-biomaterials.

• Izinsizakalo ze-GCP ne-GLP ze-bioanalytical ezisekela zonke izigaba zokuthuthukiswa kwezidakamizwa kanye nokuhlaziywa kwe-bioanalysis yesigaba esingeyona i-GLP

• Ukuhlaziywa kwe-elemental kanye nokuhlolwa kwe-trace metal ukuze kusekelwe ukuthuthukiswa kwemithi kanye nokukhiqizwa kwe-GMP

• Izifundo zokuzinza ze-GMP nokugcinwa kwe-ICH

• Ukuhlolwa ngokomzimba nokuma kwe-morphological kanye nokuchazwa kwezinto eziphilayo ezifana nosayizi wembotshana, i-pore geometry nokusabalalisa usayizi wembotshana, ukuxhumanisa, kanye ne-porosity. Amasu afana ne-microscopy ekhanyayo, i-electron microscopy (SEM) yokuskena), ukunqunywa kwezindawo ezingaphezulu ngeBET kuyasetshenziswa ukuze kubonakale izici ezinjalo. Amasu e-X-Ray diffraction (XRD) asetshenziselwa ukutadisha izinga lokucwebezela kanye nezinhlobo zesigaba ezintweni. 

• Ukuhlolwa kwemishini nokushisayo kanye nokubonakaliswa kwezinto eziphilayo ezihlanganisa ukuhlolwa okuqinile, ukucindezelwa kwengcindezi kanye nokwehluleka ukuhlola ukukhathala okuguquguqukayo ngokuhamba kwesikhathi, ukubonakaliswa kwezakhiwo ze-viscoelastic (dynamic mechanical) kanye nezifundo zokuqapha ukubola kwezakhiwo ngesikhathi sokuwohloka.

• Ukuhlaziywa kokwehluleka kwezisetshenziswa zezokwelapha, ukunqunywa kwembangela eyinhloko

IZINKONZO ZOKUBONISA

Singakusiza ukuthi uhlangabezane nezidingo zezempilo, ezemvelo nezokulawula, wakhe ukuphepha nekhwalithi enqubweni yokuklama nomkhiqizo, futhi wenze lula izinqubo zokukhiqiza. Onjiniyela bethu be-biomaterials banobuchwepheshe bokuklama, ukuhlola, amazinga, ukuphathwa kwe-supply chain, ubuchwepheshe, ukuthobela imithetho, i-toxicology, ukuphatha amaphrojekthi, ukuthuthukiswa kokusebenza, ukuphepha kanye nokuqinisekiswa kwekhwalithi. Onjiniyela bethu abangabaxhumanisi bangakwazi ukumisa izinkinga ngaphambi kokuba zibe izinkinga, basize ukuphatha nokuhlola ubungozi nezingozi, banikeze izixazululo ezintsha ezindabeni eziyinkimbinkimbi, baphakamise ezinye izindlela zokuklama, bathuthukise izinqubo futhi bathuthukise izinqubo ezingcono kakhulu zokuthuthukisa ukusebenza kahle.

UCHWEPHESHE UFAKAZI KANYE NEZINKONZO ZOKUBHELWA

Onjiniyela be-AGS-Engineering biomaterials nososayensi banolwazi lokuhlinzeka ngokuhlolwa kwezenzo ezingokomthetho zelungelo lobunikazi nesibopho somkhiqizo. Babhale imibiko yochwepheshe be-Rule 26, esizwa ekwakhiweni kwesimangalo, bafakaza ekufakweni nasekuqulweni kwecala ezimweni ezibandakanya ama-polymer, izinto zokwakha, kanye nemishini yezokwelapha ehlobene namacala womabili welungelo lobunikazi kanye nesibopho sezomthetho somkhiqizo.

Ukuze uthole usizo ngokuklama, ukuthuthukiswa nokuhlolwa kwezinto eziphilayo, xhumana nathi namuhla futhi onjiniyela bethu be-biomaterials bazokujabulela ukukusiza.

Uma unentshisekelo enkulu emandleni ethu okukhiqiza ajwayelekile esikhundleni sobunjiniyela, sincoma ukuthi uvakashele isayithi lethu lokukhiqiza ngokwezifisohttp://www.agstech.net

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Imikhiqizo yethu yezokwelapha egunyazwe yi-FDA kanye ne-CE ingatholakala ku- imikhiqizo yethu yezokwelapha, izinto ezisebenzisekayo nesayithi lemishini.http://www.agsmedical.com