Xa kuyilwa igumbi lokucoca i-GMP yokutya, ukuhamba kwabantu kunye nezinto kufuneka kwahlulwe, ukuze nokuba kukho ungcoliseko emzimbeni, lungadluliselwa kwimveliso, kwaye kunjalo nakwimveliso.
Imigaqo ekufuneka iqatshelwe
1. Abaqhubi kunye nezinto ezingena kwindawo ecocekileyo abanakwabelana ngomnyango omnye. Abaqhubi kunye neendlela zokungena zezinto kufuneka zibonelelwe ngokwahlukeneyo. Ukuba izinto eziluhlaza kunye nezinto ezincedisayo kunye nezinto zokupakisha ezidibana ngqo nokutya zipakishwe ngokuthembekileyo, aziyi kubangela ungcoliseko komnye nomnye, kwaye ukuhamba kwenkqubo kufanelekile, ngokomgaqo, kungasetyenziswa umnyango omnye. Kwizinto kunye nenkunkuma enokuthi ingcolise okusingqongileyo, njengekhabhoni esebenzayo kunye neentsalela ezisetyenzisiweyo okanye eziveliswayo ngexesha lenkqubo yemveliso, kufuneka kubekwe iindlela zokungena ezikhethekileyo kunye neendlela zokuphuma ukuze kuthintelwe ungcoliseko lwezinto eziluhlaza, izinto ezincedisayo okanye izinto zokupakisha zangaphakathi. Kungcono ukuseta iindlela zokungena ezahlukeneyo kunye neendlela zokuphuma zezinto ezingena kwindawo ecocekileyo kunye neemveliso ezigqityiweyo ezithunyelwa ngaphandle kwendawo ecocekileyo.
2. Abasebenzi kunye nezixhobo ezingena kwindawo ecocekileyo kufuneka bamisele amagumbi abo okucoca okanye bathathe amanyathelo okucoca afanelekileyo. Umzekelo, abaqhubi banokungena kwindawo yemveliso ecocekileyo nge-airlock emva kokuhlamba, benxibe iimpahla zokusebenza ezicocekileyo (kubandakanya iikepusi zokusebenza, izihlangu zokusebenza, iiglavu, iimaski, njl.njl.), ukuhlamba ngomoya, ukuhlamba izandla, kunye nokubulala iintsholongwane ngezandla. Izixhobo zinokungena kwindawo ecocekileyo nge-air lock okanye ibhokisi yepasipoti emva kokususa ukupakisha kwangaphandle, ukuhlamba ngomoya, ukucoca umphezulu, kunye nokubulala iintsholongwane.
3. Ukuze kuthintelwe ukungcoliswa kokutya zizinto zangaphandle, xa kuqulunqwa uyilo lwezixhobo zenkqubo, kufuneka kubekwe izixhobo ezinxulumene nemveliso, izakhiwo kunye namagumbi okugcina izinto kwindawo ecocekileyo yemveliso kuphela. Izixhobo zokuncedisa zikawonke-wonke ezifana neecompressors, ii-cylinders, ii-vacuum pumps, izixhobo zokususa uthuli, izixhobo zokususa ubumanzi, iifeni zokukhupha umoya zegesi ecinezelweyo kufuneka zibekwe kwindawo yemveliso ngokubanzi logama nje iimfuno zenkqubo zivuma. Ukuze kuthintelwe ngempumelelo ukungcoliswa phakathi kokutya, ukutya okuneempawu ezahlukeneyo kunye neentlobo ezahlukeneyo akunakuveliswa kwigumbi elinye elicocekileyo ngaxeshanye. Ngenxa yesi sizathu, izixhobo zalo zemveliso kufuneka zibekwe kwigumbi elahlukileyo elicocekileyo.
4. Xa uyila indlela yokungena kwindawo ecocekileyo, qiniseka ukuba indlela yokungena ifikelela ngqo kwindawo nganye yokuvelisa, indawo yokugcina izinto eziphakathi okanye izinto zokupakisha. Amagumbi okusebenzela okanye amagumbi okugcina ezinye izithuba awanakusetyenziselwa iindlela zokungena kwezinto kunye nabaqhubi kule ndawo, kwaye izixhobo ezifana ne-oven azinakusetyenziselwa iindlela zabasebenzi. Oku kunokuthintela ngempumelelo ukungcoliswa kweentlobo ezahlukeneyo zokutya okubangelwa kukuthuthwa kwezinto kunye nokuhamba komqhubi.
5. Ngaphandle kokuchaphazela ukuhamba kwenkqubo, imisebenzi yenkqubo, kunye noyilo lwezixhobo, ukuba iiparameter zenkqubo yokupholisa umoya zamagumbi okusebenza acocekileyo akufutshane ziyafana, iingcango zingavulwa kwiindonga zokwahlulahlula, iibhokisi zokuhambisa zingavulwa, okanye iibhanti zokuhambisa zingasetwa ukuhambisa izinto. Zama ukusebenzisa indlela encinci okanye engahlanganyelwanga ngaphandle kwegumbi lokusebenza elicocekileyo.
6. Ukuba indawo yokutyumza, yokuhluza, yokufumba, yokuzalisa, yokumisa i-API kunye nezinye iindawo ezivelisa uthuli oluninzi azinakuvalwa ngokupheleleyo, ukongeza kwizixhobo ezifunekayo zokubamba uthuli kunye nokususa uthuli, kufuneka kwenziwe igumbi elingaphambili lokusebenza. Ukuze kuthintelwe ukungcoliswa kwamagumbi akufutshane okanye iindlela zokuhamba ezihlanganyelweyo. Ukongeza, kwiindawo ezinobushushu obuninzi kunye nokusasazeka komswakama, njengokulungiselela ulusu oluqinileyo kunye nokulungiselela uxinaniso lwenaliti, ukongeza ekuyileni isixhobo sokususa umswakama, igumbi elingaphambili linokwenziwa ukuze kuthintelwe ukuchaphazela ukusebenza kwegumbi elicocekileyo elikufutshane ngenxa yokusasazeka komswakama okukhulu kunye nokusasazeka kobushushu kunye neeparamitha zomoya opholileyo.
7. Kungcono ukwahlula ii-lifti zokuthutha izinto kunye nee-lifti kwiifektri ezinamagumbi amaninzi. Oku kungenza kube lula ukubekwa kokuhamba kwabasebenzi kunye nokuhamba kwezinto. Ngenxa yokuba ii-lifti kunye nee-shafts zingumthombo omkhulu wongcoliseko, kwaye umoya kwii-lifti kunye nee-shafts kunzima ukuzicoca. Ke ngoko, akufanelekanga ukufaka ii-lifti kwiindawo ezicocekileyo. Ukuba ngenxa yeemfuno ezikhethekileyo zenkqubo okanye imida yesakhiwo sefektri, izixhobo zenkqubo kufuneka zicwangciswe ngokwemilinganiselo emithathu, kwaye izixhobo kufuneka zithuthwe ukusuka phezulu ukuya ezantsi okanye ezantsi ukuya phezulu kwindawo ecocekileyo yi-lifti, kufuneka kufakwe i-airlock phakathi kwe-lifti kunye nendawo yemveliso ecocekileyo. Okanye uyile amanye amanyathelo okuqinisekisa ukucoceka komoya kwindawo yemveliso.
8. Emva kokuba abantu bengene kwindawo yokusebenzela ngegumbi lokuqala lokutshintshela kunye negumbi lesibini lokutshintshela, kwaye izinto zingene kwindawo yokusebenzela ngegumbi lokuhamba kwezinto kunye negumbi lokuhamba kwabasebenzi kwi-GMP igumbi elicocekileyo alinakwahlulwa. Zonke izinto zicutshungulwa ngabantu. Umsebenzi awungqongqo kangako emva kokungena.
9. Indlela yokuhamba kwabasebenzi nayo kufuneka yenziwe ngokuthathela ingqalelo indawo iyonke kunye nokusetyenziswa kwempahla. Amanye amagumbi okutshintshela abasebenzi benkampani, amagumbi okulala, njl.njl. enzelwe iimitha ezimbalwa zesikwere, kwaye indawo yokwenyani yokutshintsha impahla incinci.
10. Kubalulekile ukuthintela ngempumelelo ukudibana kokuhamba kwabasebenzi, ukuhamba kwezinto, ukuhamba kwezixhobo, kunye nokuhamba kwenkunkuma. Akunakwenzeka ukuqinisekisa ukuba nengqondo egqibeleleyo kwinkqubo yoyilo. Kuya kubakho iintlobo ezininzi zeeworkshops zemveliso ye-collinear, kunye neendlela ezahlukeneyo zokusebenza kwezixhobo.
11. Kunjalo nakwizinto ezisetyenziswayo. Kuya kubakho iingozi ezahlukeneyo. Iindlela zokutshintsha azimiselwanga mgangatho, ukufikelela kwizinto akumiselwanga mgangatho, kwaye ezinye zinokuba neendlela zokubaleka ezingacwangciswanga kakuhle. Ukuba kwenzeka iintlekele ezifana neenyikima kunye nemililo, xa ukwindawo yokufaka impahla okanye kwindawo ekufutshane apho kufuneka utshintshe impahla izihlandlo ezininzi, eneneni kuyingozi kakhulu kuba indawo eyilwe yi-GMP clean room incinci kwaye akukho festile yokuphuma ekhethekileyo okanye indawo enokuqhekeka.
Ixesha lokuthumela: Septemba-26-2023
