Amazinga emboni yobisi amapayipi ahlanzekile

I-GMP (Umkhuba Omuhle Wokukhiqiza imikhiqizo yobisi, Umkhuba Omuhle Wokukhiqiza Wemikhiqizo Yobisi) isifinyezo se-Dairy Production Quality Management Practice futhi iyindlela yokuphatha ethuthukile nengokwesayensi yokukhiqiza ubisi. Esahlukweni se-GMP, izidingo zibekwe phambili zezinto zokwakha kanye nokwakhiwa kwamapayipi ahlanzekile, okungukuthi, "Izisetshenziswa ezithintana ngqo nemikhiqizo yobisi kufanele zibe bushelelezi futhi zingabi namazinyo noma imifantu ukuze kuncishiswe ukunqwabelana kwemfucumfucu yokudla, ukungcola nezinto eziphilayo" , “Zonke Izinto Zokukhiqiza kufanele ziklanywe futhi zakhiwe ngendlela yokuthi zihlanzeke kalula futhi zibulawe amagciwane futhi zihlolwe kalula.” Amapayipi ahlanzekile anezici zezinhlelo ezizimele kanye nobuchwepheshe obuqinile. Ngakho-ke, lesi sihloko sichaza kabanzi mayelana nokukhethwa kwezinto ezihlanzekile zamapayipi, izidingo ezingaphezulu kokuxhumana nemikhiqizo yobisi, izidingo zokushisela uhlelo lwamapayipi, ukwakheka kokuzikhipha emanzini, njll., okuhloswe ngayo ukuthuthukisa amabhizinisi obisi nokwakhiwa Ukuqonda kweyunithi ngokubaluleka kwepayipi elihlanzekile. ukufakwa nokwelashwa.

 Nakuba i-GMP ibeka phambili izidingo eziqinile zezinto zokwakha kanye nomklamo wamapayipi ahlanzekile, isimo semishini esindayo namapayipi alula sisavamile embonini yobisi yaseChina. Njengengxenye ebalulekile yenqubo yokukhiqiza ubisi, amapayipi ahlanzekile asathola ukunakwa okuncane. Akwanele kuseyisixhumanisi esibuthakathaka esikhawulela ukuthuthukiswa kwekhwalithi yomkhiqizo wobisi. Uma kuqhathaniswa namazinga afanelekile emboni yobisi yangaphandle, kusenezikhala eziningi zokuthuthukiswa. Njengamanje, izindinganiso zokuhlanzeka zaseMelika 3-A kanye namazinga e-European Hygienic Engineering Design Organisation (EHEDG) asetshenziswa kabanzi embonini yobisi yangaphandle. Ngesikhathi esifanayo, izimboni zobisi ezingaphansi kweQembu i-Wyeth e-United States ezigcizelela ukwakhiwa kwefekthri yobisi ehlangabezana nezindinganiso zemithi ziye zamukela izinga le-ASME BPE njengesicaciso esiyisiqondiso sokuklama nokufakwa kwemishini yefekthri yobisi namapayipi, okuzophinde yethulwe ngezansi.

01

Izindinganiso zezempilo zase-US 3-A

Izinga le-American 3-A lizinga lezempilo lamazwe ngamazwe elaziwayo nelibalulekile, eliqalwe yi-American 3-A Health Standards Company. I-American 3A Sanitary Standards Corporation iyinhlangano engenzi nzuzo yokubambisana ezinikezele ekukhuthazeni idizayini ehlanzekile yemishini yokukhiqiza ukudla, izinto zokukhiqiza iziphuzo, izinto zobisi nemishini yemboni yemithi, ekhuthaza kakhulu ukuphepha kokudla nokuphepha komphakathi.

I-3-A Hygiene Standards Company ihlelwe ngokuhlanganyela izinhlangano ezinhlanu ezahlukene e-United States: i-American Dairy Producers Association (ADPI), i-International Federation of Food Industry Suppliers (IAFIS), kanye ne-International Federation for Food Sanitation Protection (IAFP) , i-International Dairy Products Federation (IDFA), kanye ne-3-A Sanitary Standards Marking Council. Ubuholi be-3A buhlanganisa i-US Food and Drug Administration (FDA), uMnyango Wezolimo wase-US (USDA), kanye neKomidi Lokuqondisa le-3-A.

Izinga le-US 3-A lenhlanzeko linemithetho eqinile kumasistimu amapayipi ahlanzekile, njengasezingeni elingu-63-03 lokufakwa kwamapayipi okuhlanzeka:

(1) Isigaba C1.1, ukufakwa kwamapayipi okuthintana nemikhiqizo yobisi kufanele kwenziwe nge-AISI300 uchungechunge lwensimbi engagqwali, engagqwali, engenabuthi futhi engeke ithuthele izinto emikhiqizweni yobisi.

(2) Isigaba D1.1, ubulukhuni obungaphezulu kwenani lika-Ra lezixhumi zepayipi lensimbi engagqwali elixhumene nemikhiqizo yobisi akumele libe likhulu kuno-0.8um, futhi amakhona afile, izimbobo, izikhala, njll. kufanele kugwenywe.

(3) Isigaba D2.1, indawo yokushisela yensimbi engagqwali ethintana nemikhiqizo yobisi kufanele ishiselwe ngaphandle komthungo, futhi ubuhwaba be-Ra value yendawo yokushisela akufanele ibe nkulu kuno-0.8um.

(4) Isigaba D4.1, izixhumi zamapayipi kanye nezindawo ezithinta ubisi kufanele zizikhiphele ngokwazo uma zifakwe kahle.

02

I-EHEDG Hygienic Design Standard Yemishini Yokudla

European Hygienic Engineering & Design Group European Hygiene Engineering Design Group (EHEDG). Yasungulwa ngo-1989, i-EHEDG iyimbumba yabakhiqizi bemishini, izinkampani zezimboni zokudla, nezikhungo zezempilo zomphakathi. Umgomo wayo oyinhloko ukubeka izindinganiso eziphakeme zokuhlanzeka embonini yokudla nokupakisha.

I-EHEDG iqondise imishini yokucubungula ukudla okufanele ibe nomklamo omuhle wenhlanzeko futhi kube lula ukuyihlanza ukuze igweme ukungcoliswa kwamagciwane. Ngakho-ke, okokusebenza kudingeka kube lula ukuhlanza nokuvikela umkhiqizo ekungcoleni.

Ku-EHEDG's “Sanitary Equipment Design Guidelines 2004 Second Edition”, uhlelo lwamapayipi luchazwa kanje:

(1) Isigaba 4.1 ngokuvamile kufanele sisebenzise insimbi engagqwali ekwazi ukumelana nokugqwala;

(2) Uma inani le-pH lomkhiqizo eSigabeni 4.3 liphakathi kuka-6.5-8, ukugxila kwe-chloride akudluli ku-50ppm, futhi izinga lokushisa alidluli ku-25°C, i-AISI304 insimbi engagqwali noma i-AISI304L insimbi ye-carbon ephansi okulula ukuyishisela. kuvame ukukhethwa; uma ukugcwala kwe-chloride Uma idlula ku-100ppm futhi izinga lokushisa lokusebenza lingaphezu kuka-50 ℃, izinto ezinokumelana nokugqwala okuqinile kufanele zisetshenziselwe ukumelana nokugqwala kwe-pitting kanye nokugqwala okubangelwa ama-ion e-chloride, ngaleyo ndlela kugwenywe izinsalela ze-chlorine, njenge-AISI316 yensimbi engagqwali, futhi iphansi. insimbi ye-carbon. I-AISI316L inokusebenza okuhle kokushisela futhi ilungele amapayipi amapayipi.

(3) Indawo engaphakathi yohlelo lwamapayipi eSigabeni 6.4 kufanele izikhiphele yona futhi kube lula ukuyihlanza. Izindawo ezivundlile kufanele zigwenywe, futhi i-engeli yokuthambekela kufanele yakhelwe ukugwema ukunqwabelana kwamanzi ayizinsalela.

(4) Endaweni yokuxhumana komkhiqizo eSigabeni 6.6, indawo yokushisela kufanele ingabi namthungo futhi ibe sicaba futhi ibushelelezi. Ngesikhathi senqubo yokushisela, ukuvikelwa kwegesi ye-inert kufanele kusetshenziswe ngaphakathi nangaphandle kokuhlangana ukuze kugwenywe i-oxidation yensimbi ngenxa yokushisa okuphezulu. Ezinhlelweni zamapayipi, uma izimo zokwakha (ezifana nosayizi wesikhala noma indawo yokusebenza) zivuma, kutuswa ukusebenzisa i-othomathikhi ye-orbital welding ngangokunokwenzeka, engalawula ngokuzinza imingcele yokushisela kanye nekhwalithi yobuhlalu bokushisela.

03

I-American ASME BPE ejwayelekile

I-ASME BPE (inhlangano yaseMelika yonjiniyela bemishini, i-Bio Processing Equipment) iyindinganiso eyasungulwa yi-American Society of Mechanical Engineers ukuze ilawule ukwakheka, izinto zokwakha, ukukhiqizwa, ukuhlolwa nokuhlolwa kwemishini namapayipi okucutshungulwa kwezinto eziphilayo kanye nezingxenye zawo ezihambisanayo.

Izinga lashicilelwa okokuqala ngo-1997 ukuze kuzuzwe amazinga afanayo kanye namazinga ekhwalithi amukelekayo emishini yokukhiqiza esetshenziswa emikhiqizweni embonini ye-biopharmaceutical. Njengendinganiso yamazwe ngamazwe, i-ASME BPE ithobelana ngokugcwele nemithetho neziqondiso ezifanele ze-GMP yezwe lami kanye ne-US FDA. Kuyincazelo ebalulekile esetshenziswa yi-FDA ukuqinisekisa ukukhiqizwa. Kuyindinganiso ebalulekile yabakhiqizi bezinto ezibonakalayo namathuluzi, abahlinzeki, izinkampani zobunjiniyela nabasebenzisi bemishini. Izinga elingaphoqelekile elixhaswe ngokuhlanganyela futhi lathuthukiswa futhi libuyekezwe ngezikhathi ezithile.

3-A, EHEDG, ASME BPE amamaki ajwayelekile wesitifiketi sezempilo

Ukuze kuqinisekiswe ukukhiqizwa kwemikhiqizo ehlanzeke kakhulu futhi kuncishiswe ingozi yokungcoliswa komkhiqizo, izinga le-ASME BPE linencazelo ethile yobuchwepheshe bokushisela okuzenzakalelayo. Isibonelo, inguqulo yango-2016 inalezi zinhlinzeko ezilandelayo:

(1) SD-4.3.1(b) Uma kusetshenziswa amapayipi ensimbi engagqwali, kukhethwa impahla engu-304L noma engu-316L. I-automatic orbital welding iyindlela ekhethwayo yokuhlanganisa amapayipi. Ekamelweni elihlanzekile, izingxenye zepayipi zenziwe nge-304L noma i-316L impahla. Umnikazi, umakhi kanye nomkhiqizi kudingeka bafinyelele esivumelwaneni ngendlela yokuxhuma ipayipi, izinga lokuhlola kanye nezindinganiso zokwamukela ngaphambi kokufakwa.

(2) Ukwakhiwa kwepayipi lokushisela i-MJ-3.4 kufanele kusebenzise ukushisela okuzenzakalelayo kwe-orbital, ngaphandle uma usayizi noma isikhala singakuvumeli. Kulokhu, ukushisela ngesandla kungenziwa, kodwa kuphela ngemvume yomnikazi noma usonkontileka.

(3) MJ-9.6.3.2 Ngemva kokushisela okuzenzakalelayo, okungenani u-20% wobuhlalu bokushisela ngaphakathi kufanele buhlolwe ngokungahleliwe nge-endoscope. Uma noma yibuphi ubuhlalu be-weld obungafanelekile buvela ngesikhathi sokuhlolwa kokushisela, ukuhlolwa okwengeziwe kufanele kwenziwe ngokuvumelana nezidingo zencazelo kuze kube kwamukeleka.

04

Ukusetshenziswa kwamazinga emboni yobisi yamazwe ngamazwe

Izinga lenhlanzeko le-3-A lazalwa ngeminyaka yawo-1920s futhi liyindinganiso yamazwe ngamazwe esetshenziselwa ukumisa ukwakheka okuhlanzekile kwemishini embonini yobisi. Selokhu yathuthukiswa, cishe zonke izinkampani zobisi, izinkampani zobunjiniyela, abakhiqizi bemishini, nama-ejenti eNyakatho Melika bayisebenzisile. Kuyamukelwa futhi kwezinye izingxenye zomhlaba. Izinkampani zingafaka isicelo sokuthola isitifiketi se-3-A samapayipi, izinsimbi zamapayipi, amavalvu, amaphampu nezinye izinto zokuhlanzeka. I-3-A izohlela abahloli ukuthi benze ukuhlolwa komkhiqizo esizeni kanye nokuhlola ibhizinisi, futhi ikhiphe isitifiketi sezempilo esingu-3A ngemva kokuphumelela isibuyekezo.

Nakuba izinga lezempilo le-EHEDG laseYurophu laqala kamuva kunezinga le-US 3-A, liye lathuthuka ngokushesha. Inqubo yayo yesitifiketi iqine kakhulu kunezinga le-US 3-A. Inkampani efaka isicelo idinga ukuthumela izinto zokunikeza izitifiketi elabhorethri yokuhlola ekhethekile eYurophu ukuze zihlolwe. Isibonelo, ekuhlolweni kwepompo ye-centrifugal, kuphela uma kuphetha ngokuthi ikhono lokuzihlanza lepompo okungenani alikho ngaphansi kwekhono lokuzihlanza lepayipi eliqondile elixhunyiwe, ingabe uphawu lwesitifiketi se-EHEDG lungatholwa isikhathi esinqunyiwe.

Izinga le-ASME BPE linomlando cishe weminyaka engama-20 kusukela lasungulwa ngo-1997. Lisetshenziswa cishe kuzo zonke izimboni ezinkulu ze-biopharmaceutical kanye nezinkampani zobunjiniyela, abakhiqizi bemishini, nama-ejenti. Embonini yobisi, i-Wyeth, njengenkampani ye-Fortune 500, izimboni zayo zobisi zamukele izindinganiso ze-ASME BPE njengeziqondiso ezibekiwe zokuklama nokufakwa kwemishini yefekthri yobisi namapayipi. Bazuze njengefa imiqondo yokuphatha ukukhiqiza yezimboni zemithi futhi bamukela ubuchwepheshe bokushisela okuzenzakalelayo ukuze bakhe umugqa wokukhiqiza ubisi oluthuthukisiwe.

Ubuchwepheshe bokushisela okuzenzakalelayo buthuthukisa ikhwalithi yobisi

Namuhla, njengoba izwe linaka kakhulu ukuphepha kokudla, ukuphepha kwemikhiqizo yobisi sekuyinto ehamba phambili. Njengomphakeli wempahla yefekthri yobisi, kuwumthwalo kanye nesibopho ukuhlinzeka ngezinto ezisezingeni eliphezulu kanye nemishini esiza ukuqinisekisa ikhwalithi yemikhiqizo yobisi.

Ubuchwepheshe be-welding obuzenzakalelayo bungaqinisekisa ukuvumelana kwe-welding ngaphandle kwethonya lezici zomuntu, futhi imingcele yenqubo yokushisela njengebanga le-tungsten rod, yamanje, nesivinini sokujikeleza zizinzile. Amapharamitha ahlelekayo kanye nokuqoshwa okuzenzakalelayo kwamapharamitha wokushisela kulula ukuhlangabezana nezidingo ezijwayelekile futhi ukusebenza kahle kokukhiqizwa kokushisela kuphezulu. Njengoba kukhonjisiwe kuMfanekiso 3, ukunikezwa kwepayipi ngemuva kokushisela okuzenzakalelayo.

Inzuzo ingenye yezinto okufanele wonke usomabhizinisi wemboni yobisi azicabangele. Ngokuhlaziya izindleko, kutholakala ukuthi ukusebenzisa ubuchwepheshe bokushisela okuzenzakalelayo kudinga kuphela inkampani yokwakha ukuthi ihlomise umshini wokushisela othomathikhi, kodwa izindleko eziphelele zenkampani yobisi zizoncishiswa kakhulu:

1. Yehlisa izindleko zabasebenzi zokushisela amapayipi;

2. Ngenxa yokuthi ubuhlalu bokushisela bufana futhi bucocekile, futhi akulula ukwenza amakhona afile, izindleko zokuhlanza ipayipi le-CIP nsuku zonke ziyancipha;

3. Izingozi zokuphepha zokushisela zesistimu yamapayipi zincipha kakhulu, futhi izindleko zebhizinisi zokuphepha kobisi zehliswa kakhulu;

4. Ikhwalithi yokushisela yesistimu yamapayipi inokwethenjelwa, ikhwalithi yemikhiqizo yobisi iqinisekisiwe, futhi izindleko zokuhlolwa komkhiqizo nokuhlolwa kwamapayipi ziyancipha.