Biopharmaceuticals amatchula mankhwala opangidwa pogwiritsa ntchito sayansi ya sayansi, monga kukonzekera kwachilengedwe, mankhwala achilengedwe, mankhwala achilengedwe, ndi zina zotero. Kapangidwe, kamangidwe ndi kagwiridwe ka biopharmaceutical GMP chipinda choyera chimafuna kutsatira mosamalitsa mfundo za GMP, kuphatikiza kuwongolera ukhondo wapachipinda choyera, kutentha, chinyezi, kusiyana kwapakatikati ndi magawo ena, komanso kasamalidwe ka ogwira ntchito, zida, zida ndi zinyalala m'chipinda choyera. Nthawi yomweyo, matekinoloje apamwamba am'chipinda choyera ndi zida, monga fyuluta ya hepa, shawa ya mpweya, benchi yoyera, ndi zina zotere zimafunikanso kuwonetsetsa kuti mpweya wabwino ndi ma microbial m'chipinda choyera amakwaniritsa zofunikira.
Mapangidwe a chipinda choyera cha gmp pharmaceutical
1. Kukonzekera kwa chipinda choyera sikungakwaniritse zosowa zenizeni za kupanga. Pantchito zatsopano zokhala ndi zipinda zoyera kapena ntchito zazikulu zokonzanso zipinda zoyera, eni ake nthawi zambiri amalemba ganyu mabungwe okonza mapulani. Pazinthu zazing'ono ndi zazing'ono zazing'ono zoyera, poganizira mtengo wake, Mwiniwake nthawi zambiri amasaina mgwirizano ndi kampani ya uinjiniya, ndipo kampani ya uinjiniya ndiyo imayang'anira ntchito yokonza.
2. Kusokoneza cholinga cha kuyesa kwa chipinda choyera, kuyezetsa kachitidwe ka chipinda choyera ndi ntchito yowunikira ndi sitepe yofunikira kwambiri kuti muwone ngati zofunikira zapangidwe zimakwaniritsidwa (kuyesa kuvomereza) ndikuwonetsetsa kuti chipinda choyera chimagwira ntchito bwino (kuyesa nthawi zonse) pamene ntchito yomanga chipinda choyera itatha. Mayeso ovomerezeka ali ndi magawo awiri: kutsiriza ntchito ndi kuwunika mwatsatanetsatane momwe chipinda choyeretsera chikuyendera.
3. Mavuto akugwira ntchito m'chipinda chaukhondo
①Ubwino wampweya siwoyenera
②Kugwira ntchito mosakhazikika
③Kukonza zida sinthawi yake
④Kuyeretsa kosakwanira
⑤Kutaya zinyalala molakwika
⑥Chikoka cha zinthu zachilengedwe
Pali magawo angapo ofunikira omwe muyenera kulabadira popanga chipinda choyera chamankhwala cha GMP.
1. Ukhondo wa mpweya
Vuto la momwe mungasankhire moyenera magawo mumisonkhano yazinthu zaluso. Malinga ndi zinthu zosiyanasiyana zaluso, momwe mungasankhire moyenera magawo apangidwe ndi nkhani yofunika kwambiri pakupanga. GMP imayika patsogolo zizindikiro zofunika, ndiye kuti, milingo yaukhondo wa mpweya. Gome lotsatirali likuwonetsa milingo yaukhondo wa mpweya yomwe idafotokozedwa mu 1998 GMP ya dziko langa: Nthawi yomweyo, WHO (World Health Organisation) ndi EU (European Union) onse ali ndi zofunikira zosiyanasiyana paukhondo. . Miyezo yomwe ili pamwambayi yasonyeza momveka bwino chiwerengero, kukula, ndi chikhalidwe cha tinthu tating'onoting'ono.
Zitha kuwoneka kuti ukhondo wa fumbi lapamwamba ndi lochepa, ndipo ukhondo wa fumbi lochepa kwambiri ndilokwera. Mulingo waukhondo mumlengalenga ndiye chizindikiro chachikulu chowunika momwe mpweya ulili. Mwachitsanzo, mulingo wa 300,000 umachokera pamapaketi atsopano operekedwa ndi Medical Bureau. Pakalipano ndizosayenera kugwiritsidwa ntchito pazogulitsa zazikulu, koma zimagwira ntchito bwino zikagwiritsidwa ntchito m'zipinda zina zothandizira.
2. Kusinthana kwa mpweya
Chiwerengero cha kusintha kwa mpweya mu dongosolo la air-conditioning ndi 8 mpaka 10 kokha pa ola, pamene chiwerengero cha kusintha kwa mpweya m'chipinda choyera cha mafakitale ndi nthawi 12 pamtunda wotsika kwambiri komanso maulendo mazana angapo pamtunda wapamwamba kwambiri. Mwachiwonekere, kusiyana kwa kuchuluka kwa kusintha kwa mpweya kumayambitsa kuchuluka kwa mpweya Kusiyana kwakukulu pakugwiritsa ntchito mphamvu. Pakukonza, pamaziko a malo olondola a ukhondo, nthawi zokwanira zosinthira mpweya ziyenera kutsimikiziridwa. Kupanda kutero, zotsatira za opareshoni sizikhala zofananira, kuthekera kothana ndi kusokoneza kwa chipinda choyera kudzakhala kocheperako, mphamvu yodziyeretsa idzakulitsidwa molingana, ndipo mavuto angapo adzaposa zomwe apeza.
3. Kusiyanasiyana kwa static pressure
Pali mndandanda wa zofunikira monga mtunda pakati pa zipinda zoyera zamagulu osiyanasiyana ndi zipinda zosayera sizingakhale zosakwana 5Pa, ndipo mtunda wa pakati pa zipinda zoyera ndi kunja sungakhale wosakwana 10Pa. Njira yowongolera kusiyana kwa kuthamanga kwa static ndikupereka voliyumu ya mpweya wabwino. Zida zokakamiza zabwino zomwe zimagwiritsidwa ntchito popanga ndi ma valve otsalira otsalira, zowongolera mphamvu zamagetsi zamagetsi zamagetsi ndi zigawo zonyowetsa mpweya zomwe zimayikidwa pamalo obwereranso mpweya. M'zaka zaposachedwa, njira yosayika chipangizo chokakamiza koma kupanga voliyumu yopereka mpweya kukhala wamkulu kuposa voliyumu yobwerera ndi mpweya wotulutsa mpweya panthawi yotumiza koyamba nthawi zambiri imagwiritsidwa ntchito popanga, ndipo mawonekedwe owongolera ogwirizana nawo amathanso kukwaniritsa zomwezi.
4. Bungwe la Airflow
Ndondomeko ya kayendetsedwe ka mpweya m'chipinda choyera ndi chinthu chofunika kwambiri poonetsetsa kuti pali ukhondo. Fomu ya bungwe loyendetsa ndege yomwe nthawi zambiri imatengedwa pamapangidwe apano imatsimikiziridwa potengera ukhondo. Mwachitsanzo, zipinda zoyera za kalasi 300,000 nthawi zambiri zimagwiritsa ntchito mpweya wabwino komanso wobwerera kumtunda, kalasi ya 100000 ndi mapangidwe a zipinda zoyera za kalasi 10000 nthawi zambiri amagwiritsa ntchito mpweya wopita kumtunda komanso kutsika kwapang'onopang'ono, ndipo zipinda zoyeretsera zapamwamba zimagwiritsa ntchito njira yopingasa kapena yowongoka.
5. Kutentha ndi chinyezi
Kuphatikiza pa ukadaulo wapadera, pakuwona kutentha, mpweya wabwino ndi mpweya wabwino, makamaka umakhala ndi chitonthozo cha opareshoni, ndiko kuti, kutentha koyenera ndi chinyezi. Kuonjezera apo, pali zizindikiro zingapo zomwe ziyenera kukopa chidwi chathu, monga kuthamanga kwa mphepo yamkuntho ya tuyere duct, phokoso, kuthamanga kwa mphepo yamkuntho ya tuyere duct, phokoso, kuunikira, ndi chiŵerengero cha voliyumu ya mpweya wabwino, ndi zina zotero. lingalirani.
Mapangidwe a chipinda choyera cha Biopharmaceutical
Zipinda zoyera zachilengedwe zimagawidwa m'magulu awiri; zipinda zoyera zachilengedwe komanso zipinda zachitetezo chachilengedwe. Opanga mainjiniya a HVAC nthawi zambiri amakumana ndi akale, omwe makamaka amawongolera kuipitsidwa kwa oyendetsa ndi tinthu tamoyo. Kumbali ina, ndi chipinda choyera cha mafakitale chomwe chimawonjezera njira zotsekera. Kwa zipinda zoyera zamafakitale, mwaukadaulo wamapangidwe a HVAC, njira yofunikira yowongolera ukhondo ndikusefera ndi kukakamizidwa kwabwino. Pazipinda zoyera za biological, kuphatikiza kugwiritsa ntchito njira zofananira ndi zipinda zoyera za mafakitale, ndikofunikiranso kuganizira zachitetezo chachilengedwe. Nthawi zina ndikofunikira kugwiritsa ntchito kukakamiza koyipa kuti zinthu zisawononge chilengedwe.
Nthawi yotumiza: Dec-25-2023