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IZINTO EZIQHELEKILEYO EZINGAKUMBI KWI-A CLEAN ROOM EXABISO LOKUHLANZA NAMAQHINGA OKUPHUCULA OKUSETYENZISWAYO

Kwimveliso yamayeza angenabungozi, ukuqinisekiswa kwepateni yokuhamba komoya kwigumbi lokucoca leklasi A yinkqubo ebalulekileyo yokuqinisekisa ukuhamba komoya kwicala elinye kunye nokugcina isiqinisekiso sokungabi nazintsholongwane. Nangona kunjalo, ngexesha lemisebenzi yokuqinisekiswa nokuqinisekiswa kwehlabathi lokwenyani, abavelisi abaninzi babonisa izikhewu ezibalulekileyo kuyilo kunye nokusebenza kophando lokuhamba komoya—ingakumbi kwiindawo zeklasi A ezisebenza ngaphakathi kweklasi B—apho iingozi zokuphazamiseka komoya ezinokubakho zihlala zingathathelwa ngqalelo okanye zingavavanywa ngokwaneleyo.

Eli nqaku lihlalutya iziphene eziqhelekileyo ezibonwa ngexesha lezifundo zokubona ukuhamba komoya kwiindawo zeklasi A kwaye libonelela ngeengcebiso ezisebenzayo zokuphucula ezihambelana ne-GMP.

igumbi elicocekileyo leklasi A
igumbi elicocekileyo leklasi ye-100

Izikhewu kunye neengozi ekuqinisekisweni kwepateni yokuhamba komoya

Kwimeko ehloliweyo, indawo yeklasi A yakhiwe ngemiqobo yomzimba engaphelelanga, ishiya izithuba zesakhiwo phakathi kophahla olubiyelweyo kunye nenkqubo yomoya yokubonelela nge-FFU (Fan Filter Unit). Nangona olu lwakhiwo, uphando lokubona ukuhamba komoya aluphumelelanga ukuvavanya ngokucwangcisiweyo iimeko ezininzi ezibalulekileyo, kuquka:

1. Impembelelo yokuhamba komoya phantsi kweemeko ezingashukumiyo nezitshintshatshintshayo

Olu phononongo aluzange luvavanye indlela imisebenzi eqhelekileyo—efana nokuhamba kwabasebenzi, ukungenelela ngesandla, okanye ukuvuleka kweengcango—ngaphakathi kwendawo ejikelezileyo yeklasi B enokuchaphazela ngayo uzinzo lokuhamba komoya kwindawo yeklasi A.

2. Iingozi zokungqubana komoya kunye nokuxinana komoya

Akukho kuqinisekiswa kwenziweyo ukuze kuqinisekiswe ukuba ukuhamba komoya kweklasi B, emva kokuchaphazela izithintelo zeklasi A, izixhobo, okanye abaqhubi, kunokubangela ingxolo nokungena komoya ohambayo kwiklasi A ngokusebenzisa izikhewu zesakhiwo.

3. Iindlela zokuhamba komoya ngexesha lokuvulwa kocango kunye nokungenelela komqhubi

Uphononongo lokuhamba komoya aluzange luqinisekise ukuba ukuhamba komoya ngasemva okanye iindlela zokungcola zinokwenzeka xa iingcango zivuliwe okanye xa abasebenzi besenza ukungenelela kwiindawo ezikufutshane zeklasi B.

Ezi zinto zishiyiweyo zenza kube nzima ukubonisa ukuba ukuhamba komoya kwicala elinye kwindawo yeklasi A kunokugcinwa rhoqo ngexesha leemeko zokwenyani zemveliso, ngaloo ndlela kwazisa umngcipheko wokungcola kweentsholongwane kunye neenxalenye.

 

Iintsilelo kuYilo loVavanyo lokuBonakala koMoya kunye nokuSebenza

Uphononongo lweengxelo zokubona ukuhamba komoya kunye neerekhodi zevidiyo lutyhile imiba eliqela ephindaphindayo:

1. Uvavanyo olungaphelelanga

Kwimiqolo emininzi yemveliso—kuquka ukuzaliswa, ukucutshungulwa kwesirinji esele igcwalisiwe, kunye nokuvala—uphando lokuhamba komoya aluzange lukwazi ukugubungela ngokwaneleyo iindawo ezinobungozi obukhulu nezibalulekileyo, ezinje:

✖Iindawo ezingaphantsi kweendawo zokungenisa amanzi kwi-FFU zeklasi A

✖Iindawo zokuphuma kwi-oven yokususa i-pyrogenation kwi-tunnel, Iindawo zokususa iibhotile, Izitya zokumisa kunye neenkqubo zokutya, Iindawo zokukhupha izinto kunye neendawo zokuhambisa

✖Iindlela zomoya ngokubanzi kulo lonke indawo yokuzalisa kunye neendawo zokuhambisa umoya, ingakumbi kwiindawo zokutshintsha kweenkqubo

2. Iindlela zoVavanyo ezingezizo ezeSayensi

✖Ukusetyenziswa kweejenereyitha zomsi ezinenqaku elinye kuthintele ukubonakala kweepateni zokuhamba komoya ngokubanzi kulo lonke icandelo A

✖Umsi ukhutshwe ngqo ezantsi, nto leyo ephazamisa indlela yomoya ohamba ngayo ngokwendalo

✖Ukungenelela okuqhelekileyo kwabaqhubi (umz., ukungena kwengalo, ukudluliselwa kwezinto) akuzange kwenziwe ngendlela eqikelelweyo, nto leyo eyabangela uvavanyo olungekho ngqiqweni lokusebenza komoya

3. Uxwebhu lwevidiyo olunganelanga

Iividiyo azizange zichaze ngokucacileyo amagama egumbi, iinombolo zemigca, kunye neempawu zexesha

Ukurekhoda kwaqhekeka kwaye akuzange kuqhubeke nokubhala ukuhamba komoya kulo lonke umgca wemveliso.

Iividiyo zigxile kwiindawo zokusebenza ezizimeleyo ngaphandle kokubonelela ngembono yehlabathi jikelele yokuziphatha komoya kunye nokusebenzisana

 

Iingcebiso kunye namaqhinga okuphucula ahambelana ne-GMP

Ukuze kuboniswe ngokuthembekileyo ukusebenza komoya kwicala elinye kwigumbi lokucoca leklasi A kwaye kuhlangatyezwane nolindelo olusemthethweni, abavelisi kufuneka basebenzise olu phuculo lulandelayo:

✔Uyilo lweMeko yoVavanyo oluPhucukileyo

Ukuboniswa komoya kufuneka kwenziwe phantsi kweemeko eziguquguqukayo neziguquguqukayo ezininzi, kubandakanya ukuvulwa kweminyango, ukungenelela komqhubi okulinganisayo, kunye nokudluliselwa kwezinto, ukuze kuboniswe iimeko zokwenyani zemveliso.

✔Chaza ngokucacileyo iimfuno zobugcisa ze-SOP

Iinkqubo zokusebenza eziqhelekileyo kufuneka zichaze ngokucacileyo iindlela zokuvelisa umsi, umthamo womsi, indawo yokubeka ikhamera, iindawo zovavanyo, kunye nemigangatho yokwamkelwa ukuqinisekisa ukuhambelana nokuphindaphindwa.

✔Dibanisa imbonakalo yeHlabathi neyeNdawo yoMoya

Kucetyiswa ukusetyenziswa kwezixhobo zokuvelisa umsi ezinamanqaku amaninzi okanye iinkqubo zokubonisa umsi ezisebenza ngokupheleleyo ukuze ngaxeshanye kuthathwe iipatheni zokuhamba komoya ngokubanzi kunye nokuziphatha kokuhamba komoya kwindawo ethile kufutshane nezixhobo ezibalulekileyo.

✔Qinisa ukuRekhodwa kweVidiyo kunye noBulungisa beDatha

Iividiyo zokubonisa ukuhamba komoya kufuneka zilandelelwe ngokupheleleyo, ziqhubeke, kwaye zibhalwe ngokucacileyo, zigubungele yonke imisebenzi yeklasi A kwaye zibonise ngokucacileyo iindlela zokuhamba komoya, ukuphazamiseka, kunye neendawo ezinokubakho zomngcipheko.

igumbi elicocekileyo le-ffu
igumbi elicocekileyo

Isiphelo

Ukuqinisekiswa kwepateni yokuhamba komoya akufuneki kuthathwe njengenkqubo eqhelekileyo. Yinto esisiseko yokuqinisekisa ukungabi nazintsholongwane kwigumbi lokucoca leklasi A. Kuphela ngoyilo lovavanyo oluvakalayo ngokwesayensi, ukugubungela indawo ngokubanzi, kunye namaxwebhu aqinileyo—okanye ngokusebenzisa iinkonzo zovavanyo zobungcali ezifanelekileyo—apho abavelisi banokubonisa ngokwenene ukuba ukuhamba komoya kwicala elinye kugcinwa phantsi kweemeko zokusebenza eziyilwe neziphazamisekileyo.

Icebo eliqinileyo lokubona ukuhamba komoya libalulekile ekwakheni umqobo othembekileyo wokulawula ungcoliseko kunye nokukhusela umgangatho kunye nokhuseleko lweemveliso zamayeza ezicocekileyo.


Ixesha leposi: Disemba-29-2025