Imigangatho yoshishino lobisi kwimibhobho ecocekileyo

I-GMP (Isenzo esiLungileyo soMveliso weemveliso zobisi, iZenzo eziLungileyo zokuVelisa iiMveliso zoDai) sisishunqulelo soMsebenzi woLawulo loMgangatho weMveliso yoDai kwaye yindlela yolawulo oluphambili nenzululwazi kwimveliso yobisi. Kwisahluko se-GMP, iimfuno zibekwe phambili kwizixhobo kunye noyilo lwemibhobho ecocekileyo, oko kukuthi, "Izixhobo ezithintana ngokuthe ngqo neemveliso zobisi kufuneka zihambe kakuhle kwaye zingabi namazinyo okanye ziqhekeze ukunciphisa ukuqokelela kwenkunkuma yokutya, ukungcola kunye nezinto eziphilayo" , "Zonke izixhobo zemveliso kufuneka ziyilwe kwaye zakhiwe ukuba zicocwe ngokulula kwaye zibulawe iintsholongwane kwaye zihlolwe lula." Imibhobho ecocekileyo ineempawu zeenkqubo ezizimeleyo kunye nobugcisa obuqinileyo. Ngoko ke, eli nqaku lichaza ngokubanzi malunga nokukhethwa kwezinto ezicocekileyo zombhobho, iimfuno zomphezulu woqhagamshelwano neemveliso zobisi, iimfuno zenkqubo yepayipi ye-welding, i-self-draining design, njl. ukufakela kunye nonyango.

 Nangona i-GMP ibeka phambili iimfuno ezingqongqo zemathiriyeli kunye noyilo lwemibhobho ecocekileyo, isenzeko sezixhobo ezinzima kunye nemibhobho yokukhanya isaxhaphakile kushishino lobisi lwaseTshayina. Njengenxalenye ebalulekileyo yenkqubo yokuvelisa ubisi, iinkqubo zemibhobho ecocekileyo zisafumana ingqalelo encinane. Akwanelanga iselikhonkco elibuthathaka elithintela ukuphuculwa komgangatho wemveliso yobisi. Xa kuthelekiswa nemigangatho efanelekileyo yoshishino lobisi lwangaphandle, kusekho indawo eninzi yokuphucula. Okwangoku, imigangatho ye-American 3-A yococeko kunye nemigangatho ye-European Hygienic Engineering Design Organisation (EHEDG) isetyenziswa ngokubanzi kwishishini lobisi lwangaphandle. Kwangaxeshanye, iifektri zobisi eziphantsi kweQela le-Wyeth e-United States ezigxininisa kuyilo lwefektri yobisi oluhlangabezana nemigangatho yamayeza ziye zamkela umgangatho we-ASME BPE njengesikhokelo sokuyilwa kunye nokufakelwa kwezixhobo zomzi-mveliso wobisi kunye nemibhobho, eya kuthi kwakhona yaziswe ngezantsi.

01

US 3-A imigangatho yezempilo

Umgangatho we-American 3-A ngumgangatho owaziwayo nobalulekileyo wezempilo wamazwe ngamazwe, oqaliswe yiNkampani yeMigangatho yeMpilo yaseMelika 3-A. I-American 3A Sanitary Standards Corporation ngumbutho wobambiswano ongenzi nzuzo ozinikele ekukhuthazeni uyilo olucocekileyo lwezixhobo zokuvelisa ukutya, izixhobo zokuvelisa isiselo, izixhobo zobisi kunye nezixhobo zoshishino lwamayeza, ezikhuthaza kakhulu ukhuseleko lokutya kunye nokhuseleko loluntu.

Inkampani ye-3-A Hygiene Standards Company iququzelelwe ngokudibeneyo yimibutho emihlanu eyahlukeneyo e-United States: i-American Dairy Producers Association (ADPI), i-International Federation of Food Industry Suppliers (IAFIS), kunye ne-International Federation for Food Sanitation Protection (IAFP) , I-International Dairy Products Federation (IDFA), kunye ne-3-A ye-Sanitary Standards Marking Council. Ubunkokeli be-3A bubandakanya i-US Food and Drug Administration (FDA), iSebe lezoLimo lase-US (i-USDA), kunye neKomiti yoLawulo ye-3-A.

Umgangatho wezococeko wase-US 3-A unemigaqo engqongqo kakhulu kwiinkqubo zemibhobho ecocekileyo, njengakwinqanaba le-63-03 lofakelo lwemibhobho yococeko:

(1) Icandelo C1.1, izixhobo zombhobho ezidibanisa neemveliso zobisi kufuneka zenziwe nge-AISI300 series stainless steel, enganyangekiyo kwi-corrosion, i-non-toxic kwaye ayiyi kufuduka izinto kwiimveliso zobisi.

(2) Icandelo D1.1, uburhabaxa bomphezulu Ra ixabiso lofakelo lwemibhobho yentsimbi engenasici ekudibaneni neemveliso zobisi kufuneka lungabi ngaphezu kwe-0.8um, kunye neekona ezifileyo, imingxuma, izithuba, njl.

(3) Icandelo D2.1, umphezulu welding of steel stainless ekudibaneni neemveliso zobisi kufuneka ingenamthungo welded, kunye noburhabaxa Ra ixabiso umphezulu welding kufuneka ibe mkhulu kune 0.8um.

(4) Icandelo D4.1, izifakelo zemibhobho kunye nemigangatho yokudibanisa yobisi kufuneka ibe yinto yokuzikhupha ngokwayo xa ifakwe kakuhle.

02

I-EHEDG yoMgangatho woYilo oluHlelekileyo kuMatshini woKutya

UbuNjineli bezoBuchule baseYurophu kunye neQela loYilo lweQela lobuNjineli boBuchule baseYurophu (EHEDG). Yasekwa ngo-1989, i-EHEDG yimbumba yabenzi bezixhobo, iinkampani zoshishino lokutya, kunye namaziko ezempilo oluntu. Injongo yayo ephambili kukuseka imigangatho ephezulu yokucoceka kwishishini lokutya kunye nokupakisha.

I-EHEDG ijolise kwizixhobo zokulungisa ukutya ekufuneka zibe noyilo olucocekileyo kwaye kube lula ukucoceka ukuphepha ukungcoliseka kwe-microbial. Ngoko ke, izixhobo kufuneka kube lula ukucoca nokukhusela imveliso ekungcoleni.

Kwi-EHEDG's "Izikhokelo zoYilo lweSixhobo sococeko 2004 uHlelo lweSibini", inkqubo yemibhobho ichazwa ngolu hlobo lulandelayo:

(1) Icandelo 4.1 ngokubanzi kufuneka lisebenzise isinyithi esingenasici esinokumelana ne-corrosion;

(2) Xa ixabiso le-pH lemveliso kwiCandelo le-4.3 liphakathi kwe-6.5-8, i-chloride yoxinaniso ayidluli i-50ppm, kwaye iqondo lokushisa alidluli i-25 ° C, i-AISI304 insimbi engenasici okanye i-AISI304L yentsimbi ephantsi yekhabhoni elula ukuyidibanisa. idla ngokukhethwa; ukuba i-chloride yoxinaniso Ukuba ingaphezulu kwe-100ppm kunye nobushushu bokusebenza bungaphezulu kwe-50 ℃, izixhobo ezinokumelana ne-corrosion eyomeleleyo kufuneka zisetyenziswe ukuxhathisa i-pitting kunye ne-crevice corrosion eyenziwa yi-ion ye-chloride, ngaloo ndlela kunqandwa iintsalela zeklorini, njenge-AISI316 yensimbi engenasici, kwaye iphantsi. carbon steel. I-AISI316L inokusebenza kakuhle kwe-welding kwaye ifanelekile kwiinkqubo zemibhobho.

(3) Umphezulu wangaphakathi wenkqubo yemibhobho kwiCandelo le-6.4 kufuneka ube yi-self-drainable kwaye kulula ukuyicoca. Imiphezulu ethe tyaba kufuneka igwenywe, kwaye i-angle yokuthambekela kufuneka yenzelwe ukuphepha ukuqokelelana kwamanzi ashiyekileyo.

(4) Kwindawo yokudibanisa imveliso kwiCandelo le-6.6, i-welding joint kufuneka ingabinamthungo kwaye ibe mcaba kwaye igudileyo. Ngethuba lenkqubo ye-welding, ukukhuselwa kwegesi ye-inert kufuneka kusetyenziswe ngaphakathi nangaphandle kwe-joint ukuphepha i-oxidation yesinyithi ngenxa yokushisa okuphezulu. Kwiinkqubo zemibhobho, ukuba iimeko zokwakha (ezifana nobungakanani bendawo okanye indawo yokusebenza) zivumela, kucetyiswa ukuba kusetyenziswe ukuwelda okuzenzekelayo kwe-orbital kangangoko kunokwenzeka, okunokuthi kulawule ngokuzinzileyo iiparitha ze-welding kunye nomgangatho we-weld bead.

03

American ASME BPE umgangatho

I-ASME BPE (umbutho waseMelika weenjineli zoomatshini, i-Bio Processing Equipment) ngumgangatho ophuhliswe yi-American Society of Mechanical Engineers ukulawula uyilo, imathiriyeli, ukuveliswa, ukuhlolwa kunye novavanyo lwezixhobo ze-bioprocessing kunye nemibhobho kunye namacandelo azo ancedisayo.

Umgangatho wapapashwa okokuqala ngo-1997 ukuphumeza imigangatho efanayo kunye namanqanaba amkelekileyo omgangatho wezixhobo zokuvelisa ezisetyenziswa kwiimveliso kwishishini le-biopharmaceutical. Njengomgangatho wamazwe ngamazwe, i-ASME BPE ithobelana ngokupheleleyo nemithetho efanelekileyo kunye nemimiselo ye-GMP yelizwe lam kunye ne-US FDA. Yinkcazo ebalulekileyo esetyenziswa yi-FDA ukuqinisekisa imveliso. Ngumgangatho obalulekileyo kubenzi bezinto kunye nezixhobo, ababoneleli, iinkampani zobunjineli kunye nabasebenzisi bezixhobo. Umgangatho onganyanzelekanga oxhaswe ngokudibeneyo kwaye uphuhliswe kwaye uhlaziywe ngamaxesha athile.

3-A, EHEDG, ASME BPE amanqaku emigangatho yesiqinisekiso sezempilo

Ukuze kuqinisekiswe ukuveliswa kweemveliso ezicocekileyo kakhulu kunye nokunciphisa umngcipheko wokungcoliswa kwemveliso, umgangatho we-ASME we-BPE unenkcazo ethile ye-teknoloji ye-welding ezenzekelayo. Umzekelo, inguqulelo ka-2016 inala malungiselelo alandelayo:

(1) SD-4.3.1 (b) Xa kusetyenziswa imibhobho yensimbi engenasici, i-304L okanye i-316L impahla ikhethwa ngokubanzi. I-automatic orbital welding yindlela ekhethiweyo yokujoyina umbhobho. Kwigumbi elicocekileyo, iinqununu zepayipi zenziwe nge-304L okanye i-316L impahla. Umnini, ukwakhiwa kunye nomvelisi kufuneka afikelele kwisivumelwano malunga nendlela yokudibanisa umbhobho, inqanaba lokuhlola kunye nemigangatho yokwamkelwa ngaphambi kokufakwa.

(2) Ukwakhiwa kwemibhobho ye-MJ-3.4 kufuneka kusebenzise ukuwelda okuzenzekelayo kwe-orbital, ngaphandle kokuba ubungakanani okanye indawo ayikuvumeli. Kule meko, i-welding yesandla inokwenziwa, kodwa kuphela ngemvume yomnini okanye ikontraki.

(3) MJ-9.6.3.2 Emva kwe-welding ngokuzenzekelayo, ubuncinane i-20% yeentsimbi ze-weld zangaphakathi kufuneka zihlolwe ngokungenamkhethe nge-endoscope. Ukuba kukho nayiphi na i-weld bead engafanelekanga ibonakala ngexesha lokuhlolwa kwe-welding, uhlolo olongezelelweyo kufuneka lwenziwe ngokweemfuno zenkcazo kuze kube iyamkeleka.

04

Ukusetyenziswa kwemigangatho yoshishino lobisi lwamazwe ngamazwe

Umgangatho we-3-A wococeko wazalwa ngo-1920 kwaye ngumgangatho wamazwe ngamazwe osetyenziselwa ukulungelelanisa uyilo lococeko lwezixhobo kwishishini lobisi. Ukususela ekuphuhlisweni kwayo, phantse zonke iinkampani zobisi, iinkampani zobunjineli, abenzi bezixhobo, kunye neearhente kuMntla Merika ziye zayisebenzisa. Kwakhona kwamkelwa ngokubanzi kwezinye iindawo zehlabathi. Iinkampani zinokufaka isicelo sesiqinisekiso se-3-A semibhobho, izifakelo zemibhobho, iivalvu, iimpompo kunye nezinye izixhobo zococeko. I-3-A iya kulungiselela abaphononongi ukuba baqhube uvavanyo lwemveliso kwisiza kunye novavanyo lweshishini, kwaye bakhuphe isatifikethi sezempilo se-3A emva kokuphumelela uphononongo.

Nangona umgangatho wezempilo we-EHEDG waseYurophu waqala emva kwexesha kune-US 3-A standard, uye waphuhliswa ngokukhawuleza. Inkqubo yokuqinisekiswa kwayo ingqongqo kunomgangatho we-US 3-A. Inkampani efake isicelo kufuneka ithumele izixhobo zesiqinisekiso kwilabhoratri yovavanyo ekhethekileyo eYurophu ukuze ivavanywe. Ngokomzekelo, kuvavanyo lwempompo ye-centrifugal, kuphela xa kugqitywe ukuba isakhono sokuzicoca sempompo asikho ngaphantsi kwesakhono sokuzicoca sombhobho othe tye odityanisiweyo, unokufumaneka uphawu lwesiqinisekiso se-EHEDG. ixesha elithile elimiselweyo.

Umgangatho we-ASME BPE unembali ephantse ibe ngama-20 eminyaka ukususela ekusekweni kwawo ngo-1997. Usetyenziswa phantse kuwo onke amashishini amakhulu e-biopharmaceutical kunye neenkampani zobunjineli, abavelisi bezixhobo, kunye nee-arhente. Kushishino lobisi, i-Wyeth, njengenkampani ye-Fortune 500, iifektri zayo zobisi ziye zamkela imigangatho ye-ASME BPE njengesikhokelo soyilo kunye nokufakelwa kwezixhobo zefektri yobisi kunye nemibhobho. Baye bazuza njengelifa iingqikelelo zolawulo lwemveliso yeefektri zamayeza kwaye bamkele itekhnoloji ye-welding ezenzekelayo ukwakha umgca wemveliso yobisi oluphezulu.

Itekhnoloji ye-welding ezenzekelayo iphucula umgangatho wobisi

Namhlanje, njengoko ilizwe lihlawula ingqwalasela eyongeziweyo kukhuseleko lokutya, ukhuseleko lweemveliso zobisi lube yinto ephambili. Njengomthengisi wezixhobo zefektri yobisi, luxanduva kunye nembopheleleko yokubonelela ngezinto eziphezulu kunye nezixhobo ezinceda ukuqinisekisa umgangatho weemveliso zobisi.

Itekhnoloji ye-welding ye-automatic inokuqinisekisa ukuhambelana kwe-welding ngaphandle kwefuthe lezinto zabantu, kunye neeparitha zenkqubo ye-welding ezifana ne-tungsten intonga yomgama, okwangoku, kunye nesantya sokujikeleza zizinzile. Iiparamitha ezicwangcisiweyo kunye nokurekhodwa ngokuzenzekelayo kweeparamitha ze-welding kulula ukuhlangabezana neemfuno eziqhelekileyo kunye nokusebenza kakuhle kwemveliso ye-welding kuphezulu. Njengoko kubonisiwe kuMfanekiso 3, ukunikezelwa kombhobho emva kwe-welding ngokuzenzekelayo.

Inzuzo yenye yezinto ekufuneka usomashishini ngamnye womzi-mveliso wobisi aziqwalasele. Ngokuhlalutya iindleko, kufunyaniswe ukuba ukusebenzisa itekhnoloji ye-welding ngokuzenzekelayo kufuna kuphela inkampani yokwakha ukuba ixhobise umatshini wokuwelda ngokuzenzekelayo, kodwa iindleko ezipheleleyo zenkampani yobisi ziya kuncitshiswa kakhulu:

1. Ukunciphisa iindleko zomsebenzi wokuwelda imibhobho;

2. Ngenxa yokuba ubuhlalu be-welding bufana kwaye bucocekile, kwaye akulula ukwenza iikona ezifileyo, iindleko zokucoca umbhobho we-CIP imihla ngemihla ziyancipha;

3. Imingcipheko yokhuseleko lwewelding yenkqubo yemibhobho iyancipha kakhulu, kwaye iindleko zokhuseleko lobisi lweshishini zincitshiswa kakhulu;

4. Umgangatho we-welding we-pipeline system inokwethenjelwa, umgangatho weemveliso zobisi uqinisekisiwe, kwaye iindleko zokuvavanya imveliso kunye nokuhlolwa kwemibhobho iyancitshiswa.