Malo osungiramo zinthu zozizira a mankhwala makamaka amasunga zinthu zonse zozizira zomwe sizingatsimikizidwe kutentha kwabwinobwino. Pansi pa kutentha kochepa, mankhwala sadzawonongeka ndikukhala osagwira ntchito, ndipo nthawi yosungiramo mankhwala idzakulitsidwa. Kutentha kosungira nthawi zambiri ndi -5 °C ~ +8 °C. Kusungirako ndi kunyamula zinthu zozizira zomwe zimafuna kusungirako zinthu zozizira ndi zapadera, ndipo zimakhala ndi zofunikira zenizeni pa kutentha, chinyezi, ndi kuwoneka bwino. Pomanga malo osungiramo zinthu zozizira a mankhwala, ayenera kufufuzidwa ndikuvomerezedwa motsatira zofunikira za mtundu watsopano wa satifiketi ya GSP.
Choyamba, kusiyana pakati pa malo osungira zinthu zozizira zachipatala ndi malo osungira zinthu zozizira wamba
(1) Bolodi losungiramo zinthu zozizira:
Bolodi yosungiramo zinthu zozizira zachipatala imapangidwa ndi gulu lolimba la sandwich loteteza kutentha la polyurethane, ndipo mbale yachitsulo yokhala ndi mbali ziwiri kapena mbale yachitsulo chosapanga dzimbiri ya SUS304 imasankhidwa ndi zingwe zapamwamba komanso zingwe zolumikizira. Kulumikizana kolimba pakati pawo, magwiridwe antchito abwino kwambiri otsekera kumachepetsa kutuluka kwa mpweya wozizira ndikuwonjezera mphamvu yoteteza kutentha. Uwu ndiye ubwino wake, ndipo bolodi yosungiramo zinthu zozizira nthawi zonse imasankha, yomwe ingakhale bolodi yosungiramo zinthu ya polystyrene kapena bolodi yosungiramo zinthu ya polyurethane. Magwiridwe antchito a ziwirizi adzakhalanso osiyana.
(2) Pa zipangizo zosungiramo zinthu zozizira:
Poyerekeza ndi malo osungiramo zinthu zozizira, malo osungiramo zinthu zozizira azachipatala ayenera kukonzekera njira ina yosungiramo zinthu zozizira kuchokera mu dongosolo lokonzekera. Ngati malo osungiramo zinthu zoziziritsa kuzizira asiya kugwira ntchito chifukwa cha ngozi, malo oimikapo zinthu zozizira akhoza kupitiriza kugwira ntchito, zomwe sizingakhudze mankhwala omwe ali m'nyumba yosungiramo zinthu. Kapena katemera wozizira ndi zida zina zokhudzana ndi zinthu zomwe zimafuna kuzizira. Kumanga malo osungiramo zinthu zozizira wamba sikofunikira, ndipo kusankha zida kungasankhidwenso malinga ndi zosowa za makasitomala. Zimangofunika kukwaniritsa zinthu zomwe zingasunge zatsopano. Onani zomwe kasitomala akufuna kuti achite kapangidwe kake koyikira.
(3) Ponena za katundu wa zinthu zopangira:
Kusankha zinthu kumakhala kwakukulu kuposa kwa wamba. Zigawo zochokera kunja zidzagwiritsidwa ntchito, ndipo fakitale idzayang'aniridwa mosamala. Chepetsani kulephera kuti mupewe kuwonongeka kwa mankhwala, ndi zina zotero. Dongosolo lake lowongolera kutentha kwa firiji limagwiritsanso ntchito ukadaulo wowongolera zamagetsi wa microcomputer, ndiko kuti, popanda kugwiritsa ntchito pamanja, kutentha ndi chinyezi mu malo osungira ozizira zitha kusinthidwa ndikuwongoleredwa zokha kuti kutentha kukhale kokhazikika mu malo osungira. Itha kuyang'aniridwa ndikujambulidwa ndi chojambulira ndi chipangizo chochenjeza cholakwika; kuti zitsimikizire kuti malo osungira mankhwala mufiriji ndi otetezeka. Zofunikira zonse sizokhwima kwambiri, ndithudi, kapangidwe ndi mawonekedwe a malo osungira ozizira adzakonzedwa bwino, zomwe zitha kugwiritsidwa ntchito pamanja, kutengera zomwe kasitomala akufuna komanso kusankha zinthuzo.
(4) Pa makina owongolera zamagetsi:
Bokosi lowongolera magetsi limagwiritsa ntchito njira ziwiri zowongolera magetsi, zomwe ndi magetsi wamba komanso magetsi owonjezera, ndipo lili ndi chojambulira chapamwamba cha kutentha ndi chinyezi, chomwe chimatha kujambula ndikuwonetsa kutentha ndi chinyezi molondola m'malo ozizira. . Dongosolo lowongolera zamagetsili limatha kuwongolera mosavuta komanso momasuka kusintha kwa ma compressor akuluakulu ndi othandizira. Lili ndi ntchito zowonetsera zokha, kuyang'anira ndi alamu zokha. Limatha kuzindikira mosavuta kuwunika kopanda munthu nthawi yonseyi, zomwe zingapulumutse ogwiritsa ntchito mphamvu zambiri komanso ndalama, ndipo ndi lotsika mtengo komanso losavuta.
2. Zofunikira zina za GSP posungira mankhwala ozizira
Nkhani 83 ya satifiketi ya GSP imafuna kuti mabizinesi azisunga mankhwala moyenera malinga ndi momwe amasungiramo zinthu zoziziritsira, ndikutsatira mosamala zofunikira izi:
1. Sungani mankhwala molingana ndi kutentha komwe kwalembedwa pa phukusi. Ngati kutentha komwe kwatchulidwa sikunalembedwe pa phukusi, sungani molingana ndi zofunikira zosungira zomwe zafotokozedwa mu "Pharmacopoeia of the People's Republic of China" (Chinese Pharmacopoeia imati: kutentha kwabwinobwino kwa nyumba yosungiramo zinthu 10 ℃ ~ 30 ℃, nyumba yosungiramo zinthu yozizira 0 ℃ ~ 20 ℃, malo osungiramo zinthu ozizira 2 ℃ ~ 8 ℃);
2. Chinyezi cha mankhwala osungidwa ndi 35% ~ 75%. Nthawi yomweyo, ndi kusintha kosalekeza kwa malamulo oyenera, zofunikira pakupanga malo osungiramo mankhwala ozizira zimakonzedwanso nthawi zonse. Mu Okutobala 2013, China Food and Drug Administration idatulutsa zowonjezera zisanu, kuphatikizapo kuyang'anira kusungira ndi kunyamula mankhwala oziziritsidwa ndi ozizira, makina apakompyuta a mabizinesi amalonda a mankhwala, kuyang'anira kutentha ndi chinyezi chokha, komanso kuyang'anira kulandira ndi kutsimikizira mankhwala, monga zikalata zothandizira za "Ubwino wa Bizinesi ya Mankhwala". Zofotokozera za Management". Pakati pawo, zofunikira mwatsatanetsatane zimaperekedwa pakupanga, ntchito, kuchuluka, kugwiritsa ntchito ndi kugwiritsa ntchito njira za malo ndi zida zosungiramo mankhwala ozizira.
3. Zofunikira pa kasamalidwe ka chidziwitso cha pakompyuta, kuyang'anira kutentha ndi chinyezi chosungira, komanso kasamalidwe ka unyolo wozizira wa mankhwala zawonjezeredwa ku GSP, ndipo mabizinesi oyenerera akuyenera kupereka zikalata zotsimikizira kuti mankhwala agwiritsidwa ntchito bwino komanso moyenera panthawi yoziziritsa kuti atsimikizire kuti mankhwala ndi abwino. Chifukwa chake, kumanga ndi kukweza malo osungiramo zinthu zozizira a mankhwala kukukhala kufunikira kwa msika.
3. Kukhazikitsa, kuyambitsa ndi kumanga zida zosungiramo zinthu zozizira zachipatala kumatsatira miyezo ya dziko lonse.
“Mafotokozedwe Aukadaulo Otsimikizira Kutsimikizika kwa Magwiridwe Antchito a Malo Owongolera Kutentha ndi Zipangizo za Zinthu Zamankhwala Zozizira” (GB/T 34399-2017) “Malamulo Omanga ndi Kuvomereza Uinjiniya Wokhazikitsa Zida Zoziziritsira ndi Zipangizo Zolekanitsa Mpweya” (GB50274-2010) “Malo Opangira Madzi ndi Uinjiniya Wothira Madzi ndi Kutentha” Mafotokozedwe Ovomerezeka a Ubwino wa Kapangidwe” (GB50242-2002) “Malo Opumulira ndi Uinjiniya Woziziritsa Mpweya Kapangidwe I Mafotokozedwe Ovomerezeka a Ubwino” (GB50243-2016) “Malo Osungiramo Zinthu Zozizira Okonzedwa M'nyumba” (SB/T10797-2012) ndi atlasi yoyenera yomwe yawonetsedwa muzojambula zomanga, muyezo.
Kuphatikiza apo, pa Novembala 6, 2012, Boma lidatulutsa "Quality Management Specification for Pharmaceutical Business", "Vaccine Storage and Transportation Management Specification" ndi "Quality Management Standard for Plasma Collection Stations", zomwe zidafotokoza zofunikira za miyezo yosungiramo zinthu zozizira m'makampani opanga mankhwala.
Tsatanetsatane wake ndi uwu: Nkhani 49 ya “Good Management Practice for Drug Distribution” yomwe imagulitsa mankhwala oziziritsa ndi ozizira iyenera kukhala ndi zipangizo ndi zipangizo zotsatirazi:
(1) Ogwira ntchito za katemera ayenera kukhala ndi malo osungiramo zinthu ziwiri kapena zingapo zodziyimira pawokha zozizira;
(2) Zipangizo zowunikira kutentha zokha, zowonetsera, malamulo ndi alamu m'malo ozizira osungiramo zinthu;
(3) Ma jenereta okhazikika kapena makina opangira magetsi okhala ndi ma circuit awiri a zida zosungiramo zoziziritsa kuzizira;
(4) Pa mankhwala omwe ali ndi zofunikira zapadera kutentha kochepa, zipangizo ndi zida zomwe zimakwaniritsa zofunikira zawo zosungira ziyenera kuperekedwa;
(5) Malole osungiramo zinthu mufiriji ndi mafiriji kapena ma incubator oyikidwa m'galimoto
Nthawi yotumizira: Epulo-25-2022
