Kodi njira yopumira mpweya ya GMP Clean room ingazimitsidwe usiku wonse?

Makina opumulira mpweya a denga loyera amagwiritsa ntchito mphamvu zambiri, makamaka mphamvu ya fani yopumulira mpweya, mphamvu yoziziritsira ndi kuchotsa chinyezi m'firiji nthawi yachilimwe komanso kutentha kuti kutenthetse ndi nthunzi kuti chinyezi chikhale m'nyengo yozizira. Chifukwa chake, funso limabuka mobwerezabwereza ngati munthu angazimitse mpweya m'zipinda usiku wonse kapena pamene sizikugwiritsidwa ntchito kuti asunge mphamvu.

Sikulangizidwa kuzimitsa makina opumira mpweya kwathunthu, koma kumalangizidwa kuti musachite zimenezo. Malo, mikhalidwe ya kupanikizika, sayansi ya tizilombo toyambitsa matenda, chilichonse chidzakhala chosalamulirika panthawiyo. Izi zingapangitse njira zotsatizana zokonzanso mkhalidwe wotsatira wa GMP kukhala zovuta kwambiri chifukwa nthawi iliyonse kuvomerezedwanso kungafunike kuti mufike pamlingo woyenera wa GMP.

Koma kuchepetsa magwiridwe antchito a makina opumira mpweya (kuchepetsa kuchuluka kwa mpweya mwa kuchepetsa magwiridwe antchito a makina opumira mpweya) n'kotheka, ndipo kukuchitika kale m'makampani ena. Komabe, apanso, malamulo otsatira GMP ayenera kukwaniritsidwa musanagwiritsenso ntchito chipinda choyera ndipo njirayi iyenera kutsimikiziridwa.

Pachifukwa ichi, mfundo zotsatirazi ziyenera kutsatiridwa:

Kuchepetsa kumeneku kungachitike pokhapokha ngati malire enieni a chipinda choyera omwe aperekedwa pankhaniyi asaphwanyidwe mokwanira. Malire awa ayenera kufotokozedwa pazochitika zonse kuti agwirizane ndi momwe ntchito ikuyendera komanso momwe njira yochepetsera ikuyendera kuphatikiza mitengo yocheperako komanso yapamwamba yovomerezeka, monga kalasi ya chipinda choyera (chiwerengero cha tinthu tofanana ndi kukula kwa tinthu), mitengo yeniyeni ya chinthu (kutentha, chinyezi), mikhalidwe ya kupanikizika (kusiyana kwa kupanikizika pakati pa zipinda). Dziwani kuti mitengo yomwe ili mu njira yochepetsera iyenera kusankhidwa mwanjira yoti malowo afike pamlingo wogwirizana ndi GMP panthawi yake kupanga kusanayambe (kuphatikiza pulogalamu ya nthawi). Mkhalidwewu umadalira magawo osiyanasiyana monga zida zomangira ndi magwiridwe antchito a dongosolo ndi zina zotero. Mikhalidwe ya kupanikizika iyenera kusungidwa nthawi zonse, izi zikutanthauza kuti kubweza njira yoyendera sikuloledwa.

Kuphatikiza apo, kuyika njira yodziyimira payokha yowunikira chipinda choyera kumalimbikitsidwa mulimonse momwe zingakhalire kuti nthawi zonse muziyang'anira ndikulemba zomwe zatchulidwa pamwambapa. Chifukwa chake, mikhalidwe ya dera lomwe likukhudzidwa ikhoza kuyang'aniridwa ndikulembedwa nthawi iliyonse. Pankhani ya kupotoka (kufika pamalire) komanso payokha, ndizotheka kupeza ukadaulo woyezera ndi kuwongolera makina opumira ndikuchita zosintha zoyenera.

Pa nthawi yochepetsa, chisamaliro chiyenera kuperekedwa kuti chitsimikizire kuti palibe zinthu zina zosayembekezereka monga kulowa kwa anthu zomwe zikuloledwa. Pachifukwa ichi, kuyika chowongolera cholowera kumalangizidwa. Pankhani ya makina otsekera amagetsi, chilolezo cholowera chikhoza kulumikizidwa ndi pulogalamu yanthawi yomwe yatchulidwa pamwambapa komanso ndi makina odziyimira pawokha owunikira zipinda zoyera kotero kuti kulowa kuloledwa pokhapokha ngati kutsatiridwa ndi zofunikira zomwe zafotokozedwa kale.

Mwachidule, mayiko onse awiri ayenera kukhala oyenerera kaye kenako n’kusinthidwanso nthawi ndi nthawi ndipo miyeso yachizolowezi ya momwe ntchito ikuyendera monga kuyeza nthawi yobwezeretsa ngati malo alephera kwathunthu iyenera kuchitika. Ngati pali njira yowunikira chipinda choyera, sikofunikira - monga tafotokozera pamwambapa - kuchita miyeso ina kumayambiriro kwa ntchito pambuyo pa njira yochepetsera ngati njirayo yatsimikiziridwa. Kuyang'ana kwambiri kuyenera kuyikidwa pa njira yoyatsiranso chifukwa kusintha kwakanthawi kwa njira yoyendera n’kotheka, mwachitsanzo.

Mwachidule, pafupifupi 30% ya ndalama zamagetsi zimatha kusungidwa kutengera momwe ntchito ikuyendera komanso mtundu wa kusintha kwa magetsi, koma ndalama zina zowonjezera ndalama zingafunike kulipidwa.