IYINI I-BIOMATERIALS?

Ama-Biomaterials yinoma yiziphi izinto, zemvelo noma ezenziwe umuntu, ezihlanganisa yonke noma ingxenye yesakhiwo esiphilayo noma idivayisi ye-biomedical eyenza, ikhulise, noma imiselele umsebenzi wemvelo. Ama-Biomatadium ayizinto ezingasebenziseki ezisetshenziswa kumishini yezokwelapha, ngakho-ke ahloselwe ukusebenzisana nohlelo lwebhayoloji. Lezi zinsiza ziguqulelwe ukusetshenziswa kwezokwelapha. Ama-biomaterials angase abe nomsebenzi omuhle, njengokusetshenziselwa i-valve yenhliziyo. Ama-Biomaterials nawo asetshenziswa ekufakweni kwamazinyo, ukuhlinzwa, kanye nokulethwa kwezidakamizwa (isakhiwo esinemikhiqizo yemithi ekhulelwe singafakwa emzimbeni, okuvumela ukukhishwa isikhathi eside komuthi esikhathini eside). Ama-biomaterials awagcini nje kuphela ezintweni ezenziwe umuntu ezakhiwe ngezinsimbi noma izitsha zobumba. I-biomaterial ingase futhi ibe i-autograft, i-allograft noma i-xenograft esetshenziswa njengento yokufakelwa.

Ezinye izinhlelo zokusebenza ze-biomaterial yilezi:

• Amapuleti amathambo, Ukufakwa esikhundleni kwamalunga, usimende wethambo

• Imisipha yokwenziwa kanye nemisipha

• Ezinye izimila zamazinyo

• Ama-valve enhliziyo

• Izitho zokufakelwa zemithambo yegazi

• Imishini yokulungisa isikhumba

• Ukufakelwa kwebele

• Ama-contact lens

Ama-Biomaterials kumele ahambisane nomzimba, futhi kuvame ukuba nezinkinga zokuhambisana ne-biocompatibility. Izinkinga ezinjalo zokungahambisani zidinga ukuxazululwa ngaphambi kokuba umkhiqizo ubekwe emakethe. Kunezidingo eziqinile zokulawula ze-biomaterial. Izinkampani ezikhiqizayo ezisebenza ngama-biomaterials nazo ziyadingeka ukuthi ziqinisekise ukulandeleka kwayo yonke imikhiqizo yazo ukuze uma kutholakala umkhiqizo ongasebenzi, eminye eqoqweni elifanayo ingalandelelwa ngokushesha.

 

I-Biocompatibility yezinto eziphilayo ezindaweni ezihlukahlukene ngaphansi kwezimo ezihlukahlukene zamakhemikhali nezomzimba ziyadingeka. I-Biocompatibility ingase ibhekisele ezimpahleni ezithile zento ethile ngaphandle kokucacisa ukuthi impahla izosetshenziswa kuphi noma kanjani. Njengesibonelo, into ethile ingase ivuse ukusabela okuncane noma kungabi nhlobo kwamasosha omzimba entweni ephilayo, futhi ingase ingakwazi noma ingakwazi ukuhlangana nohlobo oluthile lweseli noma izicubu. Imishini yezokwelapha kanye nezitho zokwenziwa kuvame ukwenziwa ngezinto eziningi, ngakho-ke kungase kunganele ngaso sonke isikhathi ukukhuluma mayelana nokuvumelana kwezinto ezithile.

 

Futhi, into ethile akufanele ibe nobuthi ngaphandle uma iklanywe ngokukhethekile ukuba ibe njalo. Isibonelo amasistimu okulethwa kwezidakamizwa ahlakaniphile aqondise amangqamuzana omdlavuza futhi awabhubhise. Ukuqonda okuphelele kwe-anatomy kanye ne-physiology yendawo yesenzo kubalulekile ukuze i-biomaterial isebenze kahle. Ngakho-ke kubalulekile, ngesikhathi sokuklama, ukuqinisekisa ukuthi ukusebenza kuzohambisana futhi kube nomphumela onenzuzo ngendawo ethile ye-anatomical yokusebenza.

 

Ama-Biopolymers akhiqizwa ezintweni eziphilayo. I-Cellulose nesitashi, amaprotheni, ama-peptide, ne-DNA ne-RNA yizibonelo zama-biopolymers, lapho amayunithi e-monomeric, ngokulandelana, angushukela, ama-amino acid, nama-nucleotide. I-Cellulose yiyona kokubili i-biopolymer evame kakhulu kanye ne-organic compound evamile kakhulu eMhlabeni. Amanye ama-biopolymer ayakwazi ukubola. Okusho ukuthi, zihlukaniswa zibe yi-CO2 namanzi ngama-microorganisms. Amanye alawa ma-biopolymer abolayo angavundisi, angafakwa enqubweni yokwenza umquba wezimboni futhi azokwehla ngama-90% phakathi nezinyanga eziyisi-6. Ama-Biopolymers enza lokhu angaphawulwa ngophawu “oluvundisiwe”. Ukupakishwa okumakwe ngalolu phawu kungafakwa ezinqubweni zokwenziwa komquba ezimbonini ukuze zephule phakathi nezinyanga eziyisi-6 noma ngaphansi. Isibonelo se-polymer ehlanganisiwe ifilimu ye-PLA ngaphansi kokuqina okuthile. Amafilimu e-PLA aminyene kunalawo awafaneleki ukuvuthwa, nakuba engabola. Ukwenza umquba wasekhaya kungenza abathengi bakwazi ukulahla iphakheji ngqo endundumeni yabo yomquba.

 

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.

 

Ukudizayina Nokuthuthukiswa Kwezinto Eziphilayo

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.

 

Izinsizakalo 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

 

Consulting Services

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.

 

 

Ingcweti Yofakazi Nezinkonzo Zamacala

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 kanye nokuhlolwa kwezinto eziphilayo, ukubonisana, ufakazi ochwepheshe kanye nezinsizakalo zamacala xhumana nathi namuhla futhi abacwaningi 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