Wolemba: Smartweigh-Multihead Weighter
Zosankha zinayi zapaketi za aseptic zomwe muyenera kuziganizira. Masiku ano, matekinoloje osiyanasiyana omwe amayang'ana opanga mankhwala ndi biopharmaceutical ndi awa: (1) zipinda zoyera za 100, (2) zodzipatula, (3) zotchinga zotchinga (RABS), (4) makina ogwiritsa ntchito kamodzi. Ndi iti yomwe ili yabwino kwa inu? 1. Chipinda Choyera cha Class 100: Tekinoloje ya Cleanroom idapangidwa koyambilira m'ma 1960 kuti igwiritsidwe ntchito m'mafakitale apamlengalenga ndi zamagetsi kuti apewe kuipitsidwa ndi tizigawo tating'ono.
Mabakiteriya ndi particles, ndipo makampani opanga mankhwala posakhalitsa anazindikira kuti luso limeneli likhoza kupereka mpweya wosabala. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Zipinda zoyera za M'kalasi 100 ndizofala kwambiri popanga aseptic (ISO 5 ndi A/B Class performance ndi yofanana), pogwiritsa ntchito fyuluta yamphamvu kwambiri ya particulate air (HEPA) kuchotsa tinthu tating'onoting'ono ndi mabakiteriya. Laminar voliyumu yayikulu kapena kutuluka kwa mpweya unidirectional kumachepetsa kusamutsidwa kwa tinthu tating'onoting'ono kuchokera kumalo ena kupita kwina.
M'zaka za m'ma 1970, kudzazidwa kwa aseptic kunachitika pamakina apadera pansi pa mapanelo a HEPA. Zigawo zamakina zomwe zili pamwamba pa chidebecho ndizomwe zimatha kuipitsidwa, ndipo pakapita nthawi zimasunthidwa momwe zingathere pansi pamlingo wogwirira ntchito. Kuti muyike bwino mpweya wosefedwa pamakina, zophimba zawindo zapulasitiki zawonjezeredwanso.
Nsalu yazenera imakumbutsanso woyendetsa kuti asagwire makina kapena mankhwala. Opanga adatembenukira ku 100% denga la HEPA kuti azilamulira zipinda zonse mpaka kalasi ya 100. Izi zimathandizira kuwongolera, koma kumawonjezera ndalama zoyendetsera ntchito, makamaka makina oyendetsera mpweya.
2. Opto-Isolators: M'zaka za m'ma 80 ndi 90, odzipatula adapangidwa kuti apititse patsogolo chotchinga pakati pa anthu ndi katundu pamene amachepetsa ndalama. Wodzipatula amafotokozedwa ngati chipinda choyera m'bokosi. Njira yonseyi imatsekedwa mu kabati yosindikizidwa, yopanikizidwa ndi mpweya wosefedwa ndi zosefera za HEPA.
Panthawi yogwira ntchito, palibe wogwiritsa ntchito yemwe amaloledwa kulowa kupatula kudzera mu mawonekedwe a glove. Chithunzi mwachilolezo cha chase-logeman anchaselogeman-isolator-web.jpg for isolation system (pamwamba unit HEPA fyuluta sikuwonetsedwa). Chithunzi mwachilolezo cha chase-logeman anchase-logman-isolator-inside-web.jpg amadyetsa zodzipatula zamkati zowonetsa doko la magolovu.
Pambuyo pakupanga, chopatulacho chidzatsegulidwa, kutsukidwa, ndikukonzekera kuthamanga kwina. Ikasindikizidwanso, chopatulacho chimadzazidwa ndi sterilant, yomwe nthawi zambiri imakhala vapor hydrogen peroxide (VHP), kuti iwononge chilichonse mkati. Mosiyana ndi kupopera kwachikale kapena kupopera tizilombo toyambitsa matenda, VHP imalowa m'ming'alu yaying'ono kwambiri.
Akatsekeredwa, kukhazikitsidwa kulikonse komaliza kumachitika kudzera pa doko la magulovu. Mwachidziwitso, ziyenera kukhala zotheka kugwiritsa ntchito wodzipatula pamalo osalamulirika, monga nyumba yosungiramo katundu, ndi wogwira ntchito atavala malaya a labu. Mwangongole izo ziri.
M'malo mwake, makampani ambiri adayika zodzipatula m'zipinda zoyera za 100. Izi zimapereka gawo lowonjezera la kuyeretsa, koma phindu ndikukhazikitsa chodzipatula kuti mupewe. 3. Restricted Access Barrier System (RABS): RABS ndi mgwirizano pakati pa dongosolo lotseguka ndi dongosolo lapadera, RABS ili ndi ndondomeko mkati mwa mpanda wolimba.
Zochita zogwirira ntchito zimalowa kudzera pa doko la glove. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg RABS yotseguka imafikira padenga, kudalira makina oyendetsera mpweya ndi kusefera. RABS yotsekedwa imakhala ndi makina ake ogwiritsira ntchito mpweya ndi kusefera.
RABS ili ndi zabwino zambiri zotsika mtengo kuposa zodzipatula chifukwa cha kuphweka kwake. Izi zili choncho makamaka ngati angapezeke m’zipinda zaukhondo zomwe zilipo kale ndiyeno n’kuchepetsa ndalama zomanga. Kufunika komanga chipinda chaukhondo kumachotsa ndalama zina poyerekeza ndi zodzipatula.
4. Makina otayira: Makina opangira zinthu zotayidwa akuchulukirachulukira m'mapulogalamu a aseptic. Makinawa amakhala ndi thumba lapulasitiki lolowa m'malo mwa chitini chachitsulo chachikhalidwe. Chikwamacho chimabwera chodzaza ndi zosefera zonse, machubu, madoko, ma nozzles, ndi zina zofunika.
Imasindikizidwa mu thumba loteteza ndi chosawilitsidwa. Chopangacho chimamaliza dongosolo losabala ndikukonzekera kugwira ntchito. Chithunzi mwachilolezo cha sartorioussaritus Img_OctoPlus-_4154-web.jpg Opanga ena amapereka makina ogwiritsira ntchito kamodzi, kuphatikiza Sartorius (yake PreVAS - yovomerezeka, yosonkhanitsidwa kale, yosawilitsidwa - Project Syntegon), Pall Corporation (Biotech yake kamodzi Kugwiritsa Ntchito Kugonana System) etc.
Malinga ndi Marion Monstier, Sartorius Freeze-Thaw Products Manager, ubwino wa makina ogwiritsira ntchito kamodzi ndi awa: • Makina otsekedwa amachepetsa kusamutsa katundu ndi kusamalira, kuchepetsa chiopsezo cha kuipitsidwa. • Kusintha machitidwe ogwiritsira ntchito kamodzi pakati pa kayendetsedwe ka mankhwala kumathetsa kuthekera kwa kuipitsidwa chifukwa cha kuyeretsa kosakwanira kapena kosayenera. • Poyerekeza ndi machitidwe ogwiritsidwanso ntchito, machitidwe enawa amachepetsa kusintha ndi nthawi yokhazikitsa.
• Amachotsa zofunikira zotsimikizira kuyeretsa. • Iwo kukhetsa bwino, potero kuwonjezera mankhwala kuchira.
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