Indawo yokugcina amachiza igcina efrijini kwaye igcina zonke iintlobo zeemveliso zamayeza ezingenakuqinisekiswa phantsi kweemeko zobushushu eziqhelekileyo. Phantsi kwemeko yokubanda okuphantsi, amayeza awayi kubohla aze angasebenzi, kwaye ubomi beshelufu yamayeza buya kwandiswe. Ubushushu bokugcina ngokubanzi buyi-5 °C ~ +8 °C. Ukugcinwa kunye nokuthuthwa kweemveliso zamayeza ezifuna indawo yokubanda kukhethekile, kwaye kuneemfuno ezithile zobushushu, ukufuma, kunye nokubonakala. Xa kusakhiwa indawo yokugcina amachiza entsha, kufuneka ihlolwe kwaye yamkelwe ngokuhambelana neemfuno zenguqulelo entsha yesatifikethi se-GSP.
Okokuqala, umahluko phakathi kwendawo yokugcina ubushushu bezonyango kunye nendawo yokugcina ubushushu besiqhelo
(1) Ibhodi yokugcina izinto ezibandayo:
Ibhodi yokugcina yokugcina izinto ezibandayo yezonyango yenziwe ngepaneli yesandwich eqinileyo ye-polyurethane heat-insulating, kwaye ipleyiti yentsimbi enemibala emibini okanye ipleyiti yentsimbi engagqwali ye-SUS304 ikhethwe ngee-hook ezingaqhelekanga kunye nee-groove hooks eziphambili. Unxibelelwano oluqinileyo phakathi kwazo, ukusebenza kakuhle kokutywina kunciphisa ukuvuza komoya obandayo kwaye kuphucula isiphumo sokukhusela ubushushu. Le yinzuzo yayo, kwaye ibhodi yokugcina izinto ezibandayo ngokubanzi ikhetha, enokuba yibhodi yokugcina izinto ze-polystyrene okanye ibhodi yokugcina izinto ze-polyurethane. Ukusebenza kwezi zimbini kuya kwahluka.
(2) Kwizixhobo zokugcina izinto ezibandayo:
Xa kuthelekiswa nendawo yokugcina izinto ezibandayo ngokubanzi, indawo yokugcina izinto ezibandayo yezonyango kufuneka ilungiselele enye inkqubo yokubandisa evela kwisicwangciso sokucwangcisa. Ukuba nje, ukuba indawo yokugcina izinto ezibandayo iyeka ukusebenza ngenxa yengxakeko, indawo yokugcina izinto ezibandayo ingaqhubeka isebenza, nto leyo engayi kuchaphazela amayeza akwindawo yokugcina izinto. Okanye imijovo efrijiweyo kunye nezixhobo zemveliso ezinxulumene nayo ezifuna ukubandisa. Ukwakhiwa kwendawo yokugcina izinto ezibandayo eqhelekileyo akufuneki, kwaye ukukhethwa kwezixhobo kunokukhethwa ngokweemfuno zabathengi. Kufuneka kuphela ukuhlangabezana neemveliso ezinokuyigcina itsha. Jonga ukuba zeziphi iimfuno zomthengi ukuze enze uyilo lofakelo lwesalathiso.
(3) Ngokuphathelele iipropati zezinto ezikrwada:
Ukukhethwa kwezinto kuphezulu kakhulu kuneziqhelekileyo. Iindawo ezingenisiweyo ziya kusetyenziswa, kwaye umzi-mveliso uya kuhlolwa ngokungqongqo. Nciphisa ukwenzeka kokusilela ukuze kuthintelwe ukonakala kwamayeza, njl. Inkqubo yawo yokulawula ifriji ikwasebenzisa iteknoloji yolawulo lombane oluzenzekelayo lwe-microcomputer, oko kukuthi, ngaphandle kokusebenza ngesandla, ubushushu kunye nokufuma kwindawo yokugcina ebandayo kunokulungiswa ngokuzenzekelayo kwaye kulawulwe ukuze kufezekiswe ubushushu obuhlala buhleli kwindawo yokugcina. Ingajongwa kwaye irekhodwe yirekhoda kunye nesixhobo se-alamu yempazamo; ukuqinisekisa ukugcinwa kwamayeza efrijini okukhuselekileyo. Iimfuno eziqhelekileyo azingqongqo kangako, ewe, iinkcukacha zoyilo kunye nokufakwa kwendawo yokugcina ebandayo ziya kuphathwa ngokuchanekileyo, ezinokusebenza ngesandla, kuxhomekeke kwiimfuno zohlahlo lwabiwo-mali lomthengi kunye nokukhethwa kwezinto.
(4) Kwinkqubo yolawulo lwe-elektroniki:
Ibhokisi yokulawula yombane isebenzisa ulawulo lombane oluphindwe kabini, oko kukuthi umbane oqhelekileyo kunye nombane oxhasayo, kwaye ixhotyiswe ngerekhodi yobushushu kunye nokufuma ephucukileyo, enokurekhoda ngokuchanekileyo kwaye ibonise ubushushu kunye nokufuma kwindawo yokugcina ebandayo. . Le nkqubo yolawulo lwe-elektroniki inokulawula ngokuguquguquka nangokukhululekileyo ukutshintshwa kwee-compressors eziphambili kunye nezincedisi. Inemisebenzi yokubonisa ngokuzenzekelayo, ukujonga kunye ne-alamu ezenzekelayo. Inokwenza lula ukujonga ngokuzenzekelayo ngaphandle komntu kuyo yonke inkqubo, nto leyo enokonga abasebenzisi amandla amaninzi kunye nezixhobo zemali, kwaye iyonga kwaye ilula.
2. Ezinye iimfuno ze-GSP zokugcina ubushushu bamayeza
Inqaku 83 lesatifikethi se-GSP lifuna ukuba amashishini agcine amayeza ngokufanelekileyo ngokweempawu zawo zokukhenkcisa, kwaye alandele ngokungqongqo ezi mfuno zilandelayo:
1. Gcina amayeza ngokweemfuno zobushushu eziphawulwe kwiphakheji. Ukuba ubushushu obuthile abuphawulwanga kwiphakheji, wagcine ngokweemfuno zokugcina ezichazwe kwi-"Pharmacopoeia yeRiphabliki yabantu baseTshayina" (i-Chinese Pharmacopoeia ichaza: ubushushu obuqhelekileyo bendlu yokugcina impahla 10 ℃ ~ 30 ℃, indawo yokugcina impahla epholileyo 0 ℃ ~ 20 ℃, indawo yokugcina imithi ebandayo 2 ℃ ~ 8 ℃);
2. Umswakama ohambelanayo wamayeza agciniweyo yi-35% ~ 75%. Kwangaxeshanye, ngokuphuculwa okuqhubekayo kwemigaqo efanelekileyo, iimfuno zokwakha zokugcina izinto ezibandayo zamayeza nazo zihlala ziphuculwa. Ngo-Okthobha ka-2013, i-China Food and Drug Administration ikhuphe izihlomelo ezihlanu, kubandakanya ulawulo lokugcina nokuthutha amayeza abandayo nabandayo, inkqubo yekhompyutha yamashishini eshishini lamayeza, ukujonga ngokuzenzekelayo ubushushu kunye nokufuma, kunye nolawulo lokwamkelwa kwamayeza kunye nokuqinisekiswa, njengamaxwebhu axhasayo "Umgangatho weShishini laMayeza". Inkcazo yoLawulo". Phakathi kwazo, iimfuno ezineenkcukacha zibekwe phambili kuyilo, umsebenzi, umthamo, ukusebenza kunye neenkqubo zokusetyenziswa kwezixhobo kunye nezixhobo zokugcina izinto ezibandayo zonyango.
3. Iimfuno zolawulo lolwazi olusebenzisa ikhompyutha, ukujonga ngokuzenzekelayo ubushushu kunye nokufuma kwendawo yokugcina, kunye nolawulo lwe-cold chain yamayeza zongezwa kwi-GSP, kwaye amashishini afanelekileyo kufuneka anike amaxwebhu okuqinisekisa ukusebenza okukhuselekileyo nokusebenzayo kwamayeza ngexesha lenkqubo yokuwagcina efrijini ukuqinisekisa umgangatho wamayeza. Ke ngoko, ukwakhiwa nokuphuculwa kwendawo yokugcina amachiza kuba yimfuno yemarike.
3. Ukufakelwa, ukuqaliswa kunye nokwakhiwa kwezixhobo zokugcina ubushushu bezonyango kuhambelana nemigangatho yesizwe ngokungqongqo
“Iinkcukacha zoBugcisa zoQinisekiso lweNtsebenzo yoQinisekiso lweZixhobo zoLawulo loBushushu kunye nezixhobo zeCold Chain Logistics zeeMveliso zeMithi” (GB/T 34399-2017) “Ikhowudi yoKwakha kunye noKwamkelwa koBunjineli boFakelo lweZixhobo zeFriji kunye neZixhobo zoKwahlula umoya” (GB50274-2010) “Ubonelelo lwaManzi eZakhiwo kunye noBunjineli bokuKhupha kunye nokuFudumeza” Inkcazo yoKwamkelwa koMgangatho woKwakha” (GB50242-2002) “Umoya kunye noBunjineli bokuVula umoya kunye noMoya oQokelelweyo I Inkcazo yoKwamkelwa koMgangatho” (GB50243-2016) “Umgangatho woGcino oluBandayo oluSetyenziswe kwangaphambili lwangaphakathi” (SB/T10797-2012) kunye ne-atlas efanelekileyo eboniswe kwimizobo yokwakha, umgangatho.
Ukongeza, ngomhla wesi-6 kweyeNkanga ngowama-2012, uRhulumente ukhuphe “iMigqaliselo yoLawulo loMgangatho kwiShishini leMithi”, “iMigqaliselo yoLawulo lokuGcina nokuThuthwa kweZitofu” kunye “neMigqaliselo yoLawulo loMgangatho kwiZitishi zokuQokelelwa kwePlasma”, eyayichaza imiqathango yokugcina izinto ezibandayo kwishishini lemithi.
Iinkcukacha zezi zilandelayo: Inqaku lama-49 le-“Good Management Practice for Drug Distribution” elithengisa amayeza aqandisiweyo naqandisiweyo liza kuxhotyiswa ngezi zixhobo zilandelayo:
(1) Abasebenzi bogonyo baya kuxhotyiswa ngeendawo zokugcina izinto ezibandayo ezimbini okanye ngaphezulu ezizimeleyo;
(2) Izixhobo zokubeka esweni ubushushu ngokuzenzekelayo, irekhodi yokubonisa, ulawulo kunye ne-alamu kwindawo yokugcina ebandayo;
(3) Iiseti zejenereyitha ezilindileyo okanye iinkqubo zombane ezisebenzisa iisekethe ezimbini zezixhobo zokugcina iifriji kwindawo ebandayo;
(4) Kumayeza aneemfuno ezikhethekileyo zobushushu obuphantsi, kuya kubonelelwa ngezixhobo ezihlangabezana neemfuno zawo zokugcina;
(5) Iilori ezifakwe efrijini kunye neefriji okanye ii-incubator ezifakwe kwizithuthi
Ixesha lokuthumela: Epreli-25-2022

