I-Silica E551 Ehambisana ne-ANVISA

I-Silica Ekhishwe Ngokujwayelekile Izinga elilodwa kuzo zonke izinto zokudla, ukunakekelwa komlomo, imithi kanye nezimonyo — ilungiselelwe iBrazil neLatin America Uhlobo olulodwa lwezinga lezimboni eziningi lwe-silica emsulwa ephezulu enamanzi, ekhiqizwa ngokuhlehla okulawulwayo okumanzi. Yakhelwe ukuhlangabezana nezilinganiso zekhwalithi zamazwe ngamazwe futhi, ngasikhathi sinye, nemibhalo abalawuli baseBrazil abayilindele — ukuze umakhi wemithi akwazi ukufanelekisa into eyodwa esikhundleni ezine. Izinga lisebenza imikhakha emine eyinhloko: ukukhiqizwa kokudla, ukunakekelwa komlomo, izithako zemithi kanye nezimonyo zokunakekela umuntu. Ukusetshenziswa kwezimboni nokwengeza emfuyweni kusekelwa njengezicelo zesibili. Usayizi wezinhlayiyana, ukwakheka kwemigodi kanye namazinga okungcola konke kuyalungiseka, ngakho abathengi akudingeki ukuthi bathole futhi bafanelekise i-silica ehlukile kumugqa ngamunye wokukhiqiza. Kubakhiqizi nabanikazi bamabhrendi eBrazil nakulo lonke elaseLatin America, umphumela ongokoqobo ukuncipha kwama-SKU, ukuphathwa kwempahla okulula kanye nomsebenzi omncane wokufanelekisa. Umkhiqizi I-Zhongqi Shandong Silicon Material Co., Ltd. ikhiqiza i-silica ekhishwe ngokujwayelekile esebenza kahle eShandong, eChina. Inkampani iyibhizinisi likazwelonke lobuchwepheshe obuphezulu futhi inamalungelo obunikazi azimele ayisishiyagalombili amboza ubuchwepheshe bokukhiqiza i-silica. Imigqa yokukhiqiza ezenzakalelayo eyisithupha inika umthamo wonyaka ongaphezu kwamathani angu-80,000, okusekela ukunikezwa okungaguquki komthamo omkhulu. I-silica esetshenziswa ngokujwayelekile isebenza ngaphansi kokuphathwa okusekelwe ku-GMP. Imikhiqizo yezinga lokudla neyemithi yenziwa endaweni evaliwe ukuvimbela ukungcola okuhlukahlukene. Ukulandelelwa kumboza ukungeniswa kwezinto zokusetshenziswa, ukusabela, ukuhlolwa komkhiqizo ophelile, ukupakisha nokuthunyelwa. Yonke into yokukhiqiza inekhodi yayo, futhi amarekhodi okukhiqiza nokuhlolwa angemuva kwaleyo khodi agcinwa ukuze ahlolwe. Kubathengi baseBrazil sinikeza i-Technical Data Sheet (TDS), i-Material Safety Data Sheet (MSDS), i-Certificate of Analysis (COA) kanye nemibiko yokuqinisekisa izindlela. Ithimba lethu lobuchwepheshe lisekela amadokhumenti okubhalisa e-ANVISA kanye nezimemezelo zokuhambisana nokungenisa, futhi lingahlela ukugunyazwa kwemibhalo kanye nokuqinisekiswa kwamanxusa lapho indlela yokubhalisa ikudinga — umsebenzi ovamise ukususa umgoqo wemibhalo ohlelweni lokwethula. Impahla isivele inikezwa eYurophu, eNyakatho Melika naseNingizimu-mpumalanga Asia, futhi izicaciso zilungiselelwe izimo zaseBrazil zokusetshenziswa nezomthetho. Usayizi wezinhlayiyana, indawo ekhonjwe ngqo kanye nokumuncwa kukawoyela kuyalungiseka. Abathengi bahlanganisa amaqembu amakhulu e-FMCG asebenza eBrazil kanye nabaholi bendawo kwezokudla, ukunakekelwa komlomo, imithi, izimonyo, imfuyo nokucubungula kwezimboni. Izicaciso zobuchwepheshe — izinga elijwayelekile lomhlaba wonke Amanani ajwayelekile ngezansi. Yonke ipharamitha ingalungiselelwa uhlelo lokusetshenziswa kanye nokwakheka. Into Izinga Amanothi Okuqukethwe kwe-SiO₂ (ngokushiswa) ≥ 97.5% Isakhiwo esinamanzi esingacwebezi; akukho silica ecwebezelayo etholakele nge-X-ray diffraction Ukulahlekelwa ngokushiswa (1000 °C, ihora eli-1) ≤ 8.0% Okuqukethwe kwamanzi aboshiwe nokuzinza kokushisa Umswakama (njengoba kupakishwe, 105 °C, amahora ama-2) 3.0 – 5.5% Kubekelwe ukunciphisa ukunqwabelana nokwakheka kukagesi I-pH (i-5% yokumiswa kwamanzi) 6.5 – 7.3 Ecishe ibe phakathi; ihambisana nezinqubo eziningi zokwakheka Ukuminyana kwesamba 0.20 – 0.28 g/cm³ Kuyalungiseka emishinini ehlukene yokudla nokuxuba Ukumuncwa kukawoyela kwe-DBP 80 – 120 cm³/100 g Kubekelwe ukuqina, ukumuncwa noma umsebenzi wokuvimbela ukunqwabelana Usayizi wezinhlayiyana ophakathi (D50) 10 – 15 μm Kuyalungiseka kusuka ku-2 μm kuya ku-25 μm Indawo yobuso ye-BET 100 – 140 m²/g Isakhiwo semigodi silungiselelwe umsebenzi wokuthwala nokumuncwa Ukumhlophe (CIE L*) ≥ 97.5 Inani le-RDA (ukunakekelwa komlomo) 120 – 150 Kuyalungiseka ngamazinga ahlukene okumhlophe; ngaphansi kwezinga lokuqondisa le-RDA elingu-250 lomuthi wokuxubha wansuku zonke (ISO 11609) Izinsimbi ezisindayo i-As ≤ 1 ppm, i-Pb ≤ 2 ppm, i-Hg ≤ 0.5 ppm Imikhawulo ibekelwe ukusetshenziswa kokudla, ukunakekelwa komlomo nemithi; imiphumela yokukhiqiza ibikwa ku-COA Inani eliphelele le-aerobic plate ≤ 50 cfu/g Kuhlangabezana nezidingo zezinto eziphilayo zokusetshenziswa kokudla, imithi nezimonyo Into eyinhloko I-silica emanzi ekhishwe ngokujwayelekile Ayisebenzi ngamakhemikhali futhi izinzile ekwakheni; ukuhlukaniswa kwengozi ngokwe-SDS yomkhiqizo Ukupakisha okujwayelekile Isikhwama sephepha le-kraft elingangeni amanzi lezinga lokuthumela ngaphandle lika-10 / 15 / 20 kg eline-PE ngaphakathi Ukupakisha okwezifiso nokulebula kwangasese kuyatholakala Imigomo yokuhweba FOB Qingdao / CIF Santos / CFR Rio de Janeiro / DDP emadolobheni amakhulu aseBrazil Izixazululo eziguquguqukayo zezinhlelo ezahlukene zokungenisa Izitifiketi nemibhalo yomthetho Zonke izitifiketi zikhishwa izikhungo zangaphandle futhi zivuselelwa ngokuhlolwa kwaminyaka yonke kokuqapha. Zisekela ukukhishwa kwempahla emakasthomuni, ukufinyelela emakethe kanye namadokhumenti okubhalisa e-silica engeniswa eBrazil. 1.I-USP/NF Silicon Dioxide monograph — ikhiqizwe ngokwe-United States Pharmacopeia monograph; isebenza ekusetshenzisweni kwezithako zemithi nezinga lokudla, futhi isekela ukubhalisa kwe-ANVISA kwemithi nokudla. 2.I-ISO 22000:2018 — uhlelo lokuphathwa kokuphepha kokudla olusetshenziswa kuyo yonke inqubo yokukhiqiza. 3.I-GMP yezinto zokusetshenziswa zezimonyo nemithi — ukuphathwa kwendawo yokusebenzela kuhlangabezana nezidingo ze-GMP zokukhiqiza imithi nezimonyo. 4.I-ISO 9001:2015 — isitifiketi sokuphathwa kwekhwalithi kuyo yonke inqubo. 5.I-SHC HALAL — isitifiketi se-halal semakethe yokudla neyezimonyo ye-halal yaseBrazil. 6.I-OU KOSHER — isitifiketi se-kosher sokukhiqiza kokudla neyezimonyo kwe-kosher. 7.I-FDA 21 CFR yokuhambisana nokuxhumana nokudla — ihambisana nezidingo ze-US FDA 21 CFR zezinto ezixhumana nokudla, ezamukelwa kabanzi njengesisekelo sokuhambisana nokusetshenziswa kokuxhumana nokudla eBrazil. 8.I-FAMI-QS — ihambisana nohlelo lwekhwalithi lwezengezo zemfuyo lwe-EU; isekela ukubhalisa kwe-MAPA kwezithako zemfuyo. 9.Amalungelo obunikazi kazwelonke ayisishiyagalombili okukhiqiza i-silica ekhishwe ngokujwayelekile — impahla yobuhlakani ezimele ehlanganisa ubuchwepheshe bokukhiqiza. 10.Ibhizinisi Likazwelonke Lobuchwepheshe Obuphezulu (eChina) — ukuqashelwa okusemthethweni kwekhono le-R&D. Izici eziyinhloko zomkhiqizo 1. Ukuhlanzeka nokulawulwa kokungcola Ukuhlanzeka kufinyelela ku-≥ 97.5% SiO₂ ngokushiswa ngokusebenzisa ukuhlolwa kwezinto zokusetshenziswa, ukuhlanzwa okwizigaba eziningi nokukhiqiza okuvaliwe. I-Arsenic, i-lead ne-mercury zibanjwa emikhawulweni etafuleni elingenhla, futhi izibalo zezinto eziphilayo zilawulwa zokusetshenziswa kokudla, ukunakekelwa komlomo nezimonyo. Into ngayinye ihlolwa ngokuphelele ngaphambi kokuthunyelwa, futhi irekhodi lokuhlolwa lihamba nento — okuyikho okwenza into isetshenziswe emikhiqizweni engaphansi kwezidingo zezempilo nokuphepha ze-ANVISA. 2. Ukuzinza kwamakhemikhali nokuhambisana kokwakheka I-silica emanzi ekhishwe ngokujwayelekile izinzile ngamakhemikhali futhi ayisebenzi ngaphansi kwezimo eziphakathi noma ezine-asidi elula noma i-alkaline, futhi ayisabeli nezithako ezisebenzayo nezinto eziyisisekelo ezivame ukusetshenziswa kulezi zinhlelo. Ihambisana nezinhlelo ze-fluoride (i-sodium fluoride, i-sodium monofluorophosphate) ekunakekelweni komlomo, nama-API ezinhlotsheni zomthamo oqinile, namavithamini nezengezo ekudleni, kanye nama-emollient, izilondolozi nezinto ezisebenzayo ezimonyweni. Ukumuncwa kwezinto ezisebenzayo kuphansi ekusetshenzisweni okujwayelekile; sisatusa ukuhlolwa okufushane kokuhambisana kufomula yekhasimende ngaphambi kokukhulisa. 3. Amapharamitha alungisekayo nezinga lezifiso Amathimba ethu e-R&D nawobuchwepheshe alungisa ukusatshalaliswa kosayizi wezinhlayiyana, ukwakheka kwemigodi, ukumuncwa kukawoyela, ukuminyana kwesamba kanye nenani le-RDA ukuze kuhambisane nokusetshenziswa nokuma komkhiqizo ophelile. Lokho kuhlanganisa umuthi wokuxubha wokumhlophe ogqamile odinga amandla okuhlanza, amazinga okudla okuvimbela ukunqwabelana adinga ukugeleza, ama-glidant emithi adinga imibhalo ephelele yokuphepha, kanye namazinga ezimonyo okufiphaza adinga umuzwa wesikhumba. Ukusekelwa kusuka ekuhlolweni kwesampula kuya ekuqinisekisweni kokukhulisa. 4. Ukungaguquki phakathi kokukhiqiza Usayizi wezinhlayiyana, i-pH nokumhlophe kuqashwa ku-inthanethi ngesikhathi sokukhiqiza, futhi ukulawulwa kwekhwalithi kusuka ezintweni ezingenayo kuya ezintweni eziphelile. Ukuphambuka phakathi kwezinto kubanjwa ngaphakathi kwebhendi elincane, ngakho abathengi akudingeki baphinde balungise amafomula njalo lapho kufika into entsha. Lokho kwehlisa izindleko zokulungisa futhi kusekela ukukhiqiza okukhulu okuqhubekayo. Kungani leli zinga lifaneleka emakethe yaseBrazil 1. Izinga elilodwa elifanelekile emikhakheni emine Ukudla, ukunakekelwa komlomo, imithi nezimonyo kwabelana ngento efanayo eyisisekelo, kanti ukusetshenziswa kwezimboni nemfuyo kusekelwa eceleni. Kumaqembu aseBrazil aqhuba amabhizinisi amaningi, ukufanelekisa okukodwa kumboza ukuthuthukiswa komhlinzeki, ukuhlolwa kokungena nokuhlelwa kwempahla yemigqa eminingi yomkhiqizo — futhi kunciphisa inani lama-SKU aphethwe. 2. Ukusekelwa kwemibhalo kokungena emakethe Iqoqo lesitifiketi lamukelwa kabanzi eBrazil, futhi silungisa idokhumenti eliphelele elidingekayo ekubhaliseni kwe-ANVISA nokubhalisa kwe-MAPA kwemikhiqizo yemfuyo. Sisekela futhi ukugunyazwa kwemibhalo nokuqinisekiswa kwamanxusa lapho indlela ikudinga, futhi siphendula imibuzo yobuchwepheshe ngesikhathi sokubuyekezwa. Ukubhalisa eBrazil kuphethwe yinkampani yasekhaya engenisa; indima yethu ukunikeza iphakethe lobuchwepheshe nelamadokhumenti elisekela isicelo. 3. Izicelo ezilungiselelwe imikhuba yendawo Ukunakekelwa komlomo kulinganiswa ngokumelene namabala akhona ekusetshenzisweni kwansuku zonke kwaseBrazil — ikhofi, i-chimarrão nogwayi. Amazinga okudla ahambisana nezinongo zendawo eziyimpuphu nezilungiselelo eziyimpuphu. Amazinga ezimonyo afaneleka isidingo sendawo sokulawula uwoyela namafomula e-sunscreen ane-UV ephezulu. 4. Iphakethe eliphelele lobuchwepheshe I-TDS, i-MSDS, i-COA nemibiko yokuqinisekisa izindlela, kanye namafomula ayireferensi nemihlahlandlela yokusetshenziswa. Ithimba lethu lobuchwepheshe linikeza ukuxazulula kwezinkinga zamafomula kude, okunciphisa umsebenzi wokuthuthukisa ohlangothini lwekhasimende. 5. Ukunikezwa okuzinzile komthamo omkhulu Umthamo wonyaka ongaphezu kwamathani angu-80,000, nesitoko sokuphepha esigcinwe ezicacisweni ezijwayelekile. Samukela ama-oda ohlaka lonyaka nokulethwa okwezigaba, futhi sihlela ukukhiqiza ngaphambi kohlelo lwesidingo sekhasimende ukuze simunce ukuhamba okude kolwandle kusuka eChina kuya emachwebeni aseBrazil. 6. I-Logistics eyakhelwe iBrazil I-FOB Qingdao, i-CIF noma i-CFR Santos neRio de Janeiro, kanye nokulethwa komnyango we-DDP emadolobheni angaphakathi ahlanganisa iSão Paulo. Siphethe imibhalo yokukhishwa kwempahla yokungenisa yaseBrazil futhi sisebenza nomthumeli oqokiwe wekhasimende. Imihlahlandlela yokusetshenziswa Ukuphathwa okujwayelekile 1.Ukulandelana kokudla — engeza i-silica powder ngesikhathi sokuxuba kwempuphu eyomile. Xuba ngokufanayo nezinye izingxenye zempuphu kuqala, bese wethula izingxenye eziwuketshezi igxathu negxathu; ukuxhumana okuqondile nomthamo omkhulu woketshezi kubangela ukunqwabelana. 2.Ukusabalalisa — vumela isikhathi esanele sokuxuba kanye ne-shear efanele uhlelo lokwakheka, ukuze izinhlayiyana zisabalale ngokulinganayo futhi izinga lisebenze njengoba kucacisiwe. 3.Indawo — gcina izindawo zokukhiqiza nokugcina zomile futhi umswakama ohlobene uphakathi kwebanga elilawulwayo ukuvimbela ukuthatha umswakama nokunqwabelana. Umthamo onconywayo ngomkhakha Ukunakekelwa komlomo (i-abrasive yomuthi wokuxubha): 18% – 25% kumafomula omuthi wokuxubha wokumhlophe; lungisa ngokumelene ne-RDA eqondiwe nokusebenza kokuhlanza okudingekayo. Ukudla (ukuvimbela ukunqwabelana / usizo lokugeleza / umthwali): ngokujwayelekile 0.5% – 5%. Izinga langempela kufanele lihlale ngaphakathi kwemikhawulo yezengezo ebekwe yi-ANVISA yesigaba sokudla esithile — i-silicon dioxide ifakwe ohlwini njenge-INS 551, futhi ingeno efanele kufanele ihlolwe ngohlobo ngalunye lomkhiqizo. Izithako zemithi (i-glidant / i-anti-adherent): 0.1% – 3% ezinhlotsheni zomthamo oqinile womlomo njengamaphilisi namacapsule; lungisa ngokwezidingo zenqubo. Izimonyo nokunakekela umuntu: 2% – 15% yokuqina, ukufiphaza nokumuncwa kukawoyela kumakhrimu, ama-lotion, ama-scrub nemikhiqizo yempuphu; lungisa ngokomumo okuhlosiwe nokusebenza. Ukugcina Gcina emaphaketheni okuqala avaliwe, endaweni epholile, eyomile, enomoya, kude nomswakama nokungcola okuguquguqukayo. Isikhathi sokuphila yizinyanga ezingama-24 emaphaketheni okuqala angavulwanga ngaphansi kwezimo zokugcina ezishiwo. Phinda uvale ngokushesha ngemuva kokuvula futhi usebenzise esikhathini esifushane ukuvimbela ukuthatha umswakama nokungcola kwezinto eziphilayo. Uhla lokusetshenziswa Imikhakha eyinhloko 1. Ukunakekelwa komlomo nomuthi wokuxubha Kufanelekile emafomuleni amaningi okunakekelwa komlomo, ngokuhlanza kwe-abrasive kanye nezinga elithile lokuqina: Umuthi wokuxubha wokumhlophe — kususa ibala langaphandle futhi kucwebeza i-enamel, kuhloswe ukungcola kwekhofi, i-chimarrão nogwayi okuvamile eBrazil, ne-RDA engaphakathi kwebanga elamukelwa umhlaba wonke. Umuthi wokuxubha wansuku zonke wokuhlanza ngokujulile — kususa i-plaque futhi kucwebeza indawo yezinyo; kuhambisana nezinhlelo zokunambitha ze-mint nezithelo ezisetshenziswa emakethe yaseBrazil. Umuthi wokuxubha ocacile — izicaciso zihambisana ne-refractive index yesisekelo, ukuze kube nokucaca okuphezulu kwe-paste ngokuhlanza okulula nokuqina. Impupu yamazinyo ne-paste yokucwebeza yobungcweti — ukugeleza okuhle kwempuphu nokusebenza kokucwebeza kwempuphu yamazinyo nama-paste e-prophylaxis yobungcweti. 2. Ukukhiqizwa kokudla Kusetshenziswa njengesengezo sokudla esivunyelwe, i-silicon dioxide (E551 / INS 551): Ukuvimbela ukunqwabelana ekudleni okuyimpuphu — izinongo eziyimpuphu, ikhofi elisheshayo, impuphu ye-chimarrão, impuphu yobisi, i-creamer, usawoti odliwayo noshukela we-icing; kuvimbela ukuthatha umswakama nokunqwabelana futhi kuthuthukisa ukugeleza. Usizo lokucubungula kubhiya neziphuzo — usizo lokucacisa olumunca i-protein ne-polyphenol haze, kuthuthukisa ukucaca futhi kwandise isikhathi sokuphila. Umthwali wezithako zokudla — umthwali wokumuncwa wokunambitha oketshezi, ama-sweetener nezinto zokuqinisa okudla, kuziguqula zibe yimpuphu egelezayo ngokukhululekile. Izicelo zokuxhumana nokudla — kuhlangabezana nezidingo zezinto zokuxhumana nokudla, kuhlanganisa ama-sachet e-desiccant nokunye ukusetshenziswa kokuxhumana okungaqondile. 3. Izithako zemithi Kukhiqizwa ngokwe-USP/NF monograph futhi kusetshenziswa ezinhlotsheni zomthamo oqinile womlomo: Amaphilisi namacapsule — i-glidant ne-anti-adherent; kuthuthukisa ukugeleza kwempuphu, kunciphisa ukungqubuzana nama-punch nama-die, kuthuthukisa ukunemba kwesisindo nokuqedwa kwendawo, futhi kuvimbela ukunamathela. Impuphu nama-granule — usizo lokugeleza nomthwali; kuthuthukisa ukufana kwezinto ezisebenzayo zomthamo ophansi nokuzinza kokulungiselela. Ukusekelwa kokubhalisa — idatha yobuchwepheshe edingekayo ekubhaliseni imithi eBrazil inikezwa nento. 4. Izimonyo nokunakekela umuntu Ukuqina, ukulawula kwe-rheology, ukufiphaza, ukumuncwa kukawoyela nokusebenza kwe-soft-focus: Ukunakekela isikhumba — amakhrimu, ama-lotion, ama-serum nama-scrub; kulungisa umumo, kuthuthukisa ukuzinza, kunika umuzwa kasilika, futhi kunikeza ukuxubha okulula kumafomethi e-scrub. Izimonyo — impuphu ekhululekile necindezelwe, i-foundation ne-primer; umphumela we-soft-focus, kufiphalisa izimbobo nemigqa emincane, kumunca uwoyela owedlulele futhi kwandise isikhathi sokugqoka. I-sunscreen — kuthuthukisa ukusabalala, kunciphisa ukunamathisela nokuthuthukisa umuzwa wangemuva. Ukunakekela izinwele — i-shampoo eyomile nemikhiqizo yokulawula uwoyela; kumunca uwoyela wekhanda futhi kwengeza umthamo. Imikhakha yesibili Izimboni Isigcwalisi esisebenzayo esingajwayelekile se-inorganic sokusetshenziswa: Ama-coatings nama-inki — i-agent yokufiphaza, i-agent yokuvimbela ukuhla nokuthuthukisa ukumelana nokuklwebheka kuzinhlelo zamanzi nezincibilikisi. I-silicone rubber — isigcwalisi esiqinisayo esithuthukisa amandla okudonsa nokumelana nokudabuka. Iphepha nezinye izimboni — isigcwalisi sephepha, i-adsorbent yezimboni nomthwali we-catalyst. Izengezo zemfuyo Kugunyazwe i-FAMI-QS, kuhambisana nezidingo zokuphepha kwemfuyo zaseBrazil: I-agent yokuvimbela ukunqwabelana nosizo lokugeleza kwe-premix, i-concentrate nezengezo zemfuyo eziyimpuphu. Umthwali wezinto ezincane, amavithamini nezinye izengezo zokudla, kuthuthukisa ukuzinza nokusabalala. Imibhalo yobuchwepheshe namasampula kuyatholakala uma kuceliwe.