Ingabe Amathangi e-GFS Avunyelwe yi-FDA Ukuthintana Nokudla?
Ibinzana elithi 'FDA approved tank' livela kumawebhusayithi amaningi abahlinzeki nasemibhalweni eminingi yezinkondlo, futhi liphutha ngendlela ebalulekile. I-US Food and Drug Administration ayigunyazi amathangi okugcina. Ilawula izinto ezithintana nokudla, futhi ikwenza lokho ngohlaka lwemithethonqubo nokukhululwa kunokuba ikhiphe izitifiketi zemikhumbi eqediwe. Umhlinzeki othi ugunyazwe yi-FDA ethangini uyenza lula noma akakuqondi kahle lolu hlelo.
Okufanele umthengi akufune futhi akwazi ukukufuna isitatimende sokuthobela imithetho esibhalwe phansi: ukuthi ukwakheka kokumboza kuhlanganisa izinto ezivunyelwe ukuthintana nokudla ngaphansi komthethonqubo ofanele, kusekelwa idatha yokuhlolwa kokukhishwa noma kokufuduka. Kwezinsimbi ezinengilazi ehlanganisiwe, i-Center Enamel ihlinzeka ngemibhalo yokuthobela ukumboza ngokumelene ne-21 CFR 175.300 yezinto ezinamafutha nezepholima, kanye ne-NSF/ANSI 61 yamanzi okuphuza ne-LFGB yemakethe yaseYurophu.
1. Ingabe i-FDA Igunyaza Amathangi?
Cha. I-FDA ilawula izinto nezinto ezithinta ukudla; ayiqinisekisi, ayigunyazi noma ayibhali amathangi okugcina aphelele. Ulwimi olufanele 'ukuhambisana' nomthethonqubo oqokiwe.
· Umthethonqubo, Hhayi Ukuvunyelwa: Ukuhambisana kuboniswa ngokumelene nomthethonqubo othile - ngokuvamile i-21 CFR 175.300 yezinto ezinamafutha nezinto zokwakha - hhayi ngokumelene nesitifiketi esikhishwe yi-FDA.
· Ukugoqwa Kuyindawo Yokuthintana Nokudla: Ukwakheka kokugoqwa, hhayi insimbi noma ubunjiniyela bethangi, okumele kuhlangabezane nomthethonqubo.
· Ukwakheka Kanye Nemininingwane Yokuhlolwa: Isimangalo esinengqondo sihlanganisa isitatimende sokuthi zonke izingxenye ziyizinto ezivunyelwe kanye nemiphumela yokuhlolwa kokukhishwa noma ukufuduka okwenziwe ngendlela eyaziwayo.
· Ukuthi Kungani Umehluko Ubalulekile: Ukucaciswa okumane kuthi 'kuvunyelwe yi-FDA' akunakusebenza; lokho okucaphuna umthethonqubo nendlela yokuhlola kungahlolwa.
2. Yimuphi Umthethonqubo Okusebenzayo Ngempela?
Ngethangi lensimbi elinengqimba, isitatimende esilawulayo ngokuvamile ngu-21 CFR 175.300, esimayelana nengqimba yama-resin nama-polymer ehloselwe ukuthintana nokudla okuphindaphindiwe.
· 21 CFR 175.300: Ichaza izinto ezivunyelwe kuma-resin nama-polymer coatings kanye nezimo zokusetshenziswa, okuhlanganisa nemikhawulo yokukhishwa.
· NSF/ANSI 51: Izinga laseNyakatho Melika lezinto zempahla yokudla - isitifiketi sokuzithandela abacubunguli bokudla abaningi abasibheka ngempela.
· NSF/ANSI 61: Izinga lamanzi okuphuza, elidingekayo lapho ithangi liphethe amanzi ahlanzekile kunokuba kube umkhiqizo wokudla.
· Uhlaka lwe-EU: Umthethonqubo 1935/2004 uyisisekelo, i-EU 10/2011 ihlanganisa amapulasitiki, futhi izinhlelo zikazwelonke ezifana ne-LFGB yaseJalimane zinikeza uhlelo lokuhlola abathengi abaningi baseYurophu abaludingayo.
· Ama-Sealants nama-Gaskets: Ukuthobela ukuthintana nokudla kusebenza kuyo yonke ingxenye emanzi, okuhlanganisa i-sealant yokuhlangana, ama-gasket kanye nezinsimbi zomlomo wethiyubhu - hhayi nje ukumboza kwephaneli.
3. Yini Okufanele Umthengi Ayicele?
Umthethonqubo oqokiwe, isitatimende sokuthobela esihlanganisa yonke ingxenye emanzi, kanye nombiko wokuhlola osekelayo. Okunye ngaphandle kwalokho kuyisimangaliso sokumaketha.
· Isitatimende Sokuthobela Esibhaliwe: Sisho umthethonqubo, uhlelo lokumboza kanye nomkhiqizi, ephepheni lenkampani.
· Umbiko Wokuhlola: Ukuhlolwa kokukhishwa noma ukufuduka okwenziwa ngendlela eyaziwayo yilabhorethri enekhono.
· Ukumboza Kwezingxenye: Ukuqinisekisa ukuthi i-sealant, ama-gasket kanye nezingxenye ezithintana nomkhiqizo nazo zisezingeni lokudla.
· Ukuhambisana Nokuhlanzwa: Ukuqinisekisa ukuthi ukumboza kumelana nenqubo ehlosiwe yokuhlanza nokubulala amagciwane, okuhlanganisa izinga lokushisa nokugxila kwamakhemikhali.
· Ukulandeleka: Ukuhlonza iqoqo lokukhiqiza elixhumanisa amaphaneli ahlinzekiwe nokwakheka kokumboza okuhloliwe.
Isitifiketi Noma Umthethonqubo | Ububanzi | Lapho Kusebenza Khona |
21 CFR 175.300 | Ukumboza kokudla okuthintana nokudla okwenziwe nge-resin ne-polymer | United States, izindawo ezithintana nokudla |
NSF/ANSI 51 | Izinto zempahla yokudla | North America, imishini yokucubungula ukudla |
NSF/ANSI 61 | Izingxenye zohlelo lwamanzi okuphuza | Ukugcinwa nokusabalalisa amanzi ahlanzekile |
EU 1935/2004 | Uhlaka lwazo zonke izinto ezithintana nokudla | European Union |
LFGB | Ikhodi kazwelonke yokudla nokudla kwezilwane enohlelo lokuhlola | IGermani futhi yamukelwa kabanzi eYurophu |
Ukuqinisekiswa Kobunjiniyela Nokusekwa Kwephrojekthi
Wonke ithangi elethwa yi-Shijiazhuang Zhengzhong Technology Co., Ltd. (Center Enamel) lakhiwe ngokuya nge-AWWA D103-09 kanye ne-EN 1090, nokuqinisekiswa nge-finite element kokulayisha kwegobolondo, uphahla kanye nemilomo, kuhlanganiswe ngezinga lokushisa elingu-820-930°C ngaphansi kokulawulwa yi-ISO 9001 kanye ne-ISO 45001, kuhlolwe nge-holiday test ku-1500 V kuyo yonke indawo ngamaphesenti ayikhulu, futhi kuhlanganiswe ngamabhawudi e-Grade 8.8 kanye ne-sealant eqinisekiswe ngumkhiqizi. Amaphrojekthi ezinga lokudla anikezwa imibhalo yokuqinisekisa ukumbozwa, imininingwane ye-sealant nama-gasket, imihlahlandlela yokuhambisana nokuhlanzwa kanye nokulandeleka kwe-batch kwamaphaneli alethiwe.
Imibuzo Ejwayelekile (FAQ)
Ingabe i-FDA ivumela amathangi okugcina?
Cha. I-FDA ayivumeli noma iqinisekise amathangi okugcina aseqediwe. Ilawula izinto ezithintana nokudla, ngakho isimangalo esinengqondo ukuthi ukumbozwa kwethangi kuhambisana nomthetho othile njenge-21 CFR 175.300, okusekelwa idatha yokuhlolwa kokukhipha.
Iyini i-21 CFR 175.300?
Ungumthetho wase-US obheka izinto zokumboza ezinhlaka ezihlanganisa ama-resin nama-polymer ezihloselwe izindawo ezithintana nokudla. Ubala izinto ezivunyelwe futhi ubeka izimo zokusetshenziswa, futhi yisona sikhombo esivame ukusetshenziswa ekumbozeni ithangi lensimbi elisezingeni lokudla.
Ingabe i-FDA iyafana nokuqinisekiswa kwe-NSF?
Cha. I-FDA iwuhlaka olumisayo olubeka izidingo zomthetho; i-NSF iyinhlangano yokuqinisekisa yokuqala yomuntu wesithathu ehlola futhi iqinisekise imikhiqizo ngokuya ngezindinganiso ezifana ne-NSF/ANSI 51 yemishini yokudla ne-NSF/ANSI 61 yamanzi okuphuza.
Yikuphi ukuqinisekiswa okudingekayo eYurophu?
UMthetho 1935/2004 uhlinzeka ngohlaka lwazo zonke izinto ezithintana nokudla, futhi izinhlelo zikazwelonke ezifana ne-LFGB yaseJalimane zinikeza uhlelo oluningiliziwe lokuhlola. Abathengi abaningi baseYurophu bacela ngokuqondile imibiko yokuhlola ye-LFGB ngokufakwa kwengqimba.