Intshukumo yolwelo ayinakwahlulwa kwisiphumo "somahluko woxinzelelo". Kwindawo ecocekileyo, umahluko woxinzelelo phakathi kwegumbi ngalinye xa kuthelekiswa nomoya wangaphandle ubizwa ngokuba "ngumahluko woxinzelelo olupheleleyo". Umahluko woxinzelelo phakathi kwegumbi ngalinye elikufutshane nendawo ekufutshane ubizwa ngokuba "ngumahluko woxinzelelo oluhambelanayo", okanye "umahluko woxinzelelo" ngamafutshane. Umahluko woxinzelelo phakathi kwegumbi elicocekileyo kunye namagumbi adibeneyo akufutshane okanye iindawo ezingqongileyo yindlela ebalulekileyo yokugcina ucoceko lwangaphakathi okanye ukunciphisa ukusasazeka kongcoliseko lwangaphakathi. Amashishini ahlukeneyo aneemfuno ezahlukeneyo zomahluko woxinzelelo kumagumbi acocekileyo. Namhlanje, siza kwabelana nawe ngeemfuno zomahluko woxinzelelo kwiinkcukacha ezininzi eziqhelekileyo zegumbi elicocekileyo.
Ishishini lamayeza
①I-"Good Manufacturing Practice for Pharmaceutical Products" icacisa oku: Umahluko woxinzelelo phakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga kunye naphakathi kweendawo ezahlukeneyo ezicocekileyo akufuneki ube ngaphantsi kwe-10Pa. Xa kuyimfuneko, kufuneka kugcinwe i-gradients efanelekileyo yoxinzelelo phakathi kweendawo ezahlukeneyo ezisebenzayo (amagumbi okusebenzela) ezikumgangatho ofanayo wococeko.
②I-"Veterinary Drug Manufacturing Good Manufacturing Practice" ichaza oku: Umahluko phakathi kwamagumbi acocekileyo akufutshane (iindawo) anamanqanaba ahlukeneyo okucoceka komoya kufuneka abe ngaphezulu kwe-5 Pa.
Umahluko phakathi koxinzelelo olungashukumiyo phakathi kwegumbi elicocekileyo (indawo) kunye negumbi elingacocekanga (indawo) kufuneka libe ngaphezulu kwe-10 Pa.
Umahluko phakathi koxinzelelo olungashukumiyo phakathi kwegumbi elicocekileyo (indawo) kunye nomoya ongaphandle (kuquka iindawo eziqhagamshelwe ngqo ngaphandle) kufuneka ube ngaphezulu kwe-12 Pa, kwaye kufuneka kubekho isixhobo esibonisa umahluko woxinzelelo okanye inkqubo yokubeka esweni kunye ne-alamu.
Kwiiworkshops zegumbi elicocekileyo leemveliso zebhayoloji, ixabiso elipheleleyo lomahluko woxinzelelo olungaguqukiyo oluchazwe apha ngasentla kufuneka limiselwe ngokweemfuno zenkqubo.
③Imigangatho yoYilo lweGumbi lokuCoca aMachiza icacisa oku kulandelayo: Umahluko phakathi kwamagumbi acocekileyo ezonyango anamanqanaba ahlukeneyo okucoceka komoya kunye naphakathi kwamagumbi acocekileyo namagumbi angacocekanga akufuneki abe ngaphantsi kwe-10Pa, kwaye umahluko phakathi kwamagumbi acocekileyo ezonyango kunye nomoya ongaphandle akufuneki ube ngaphantsi kwe-10Pa.
Ukongeza, amagumbi acocekileyo alandelayo eyeza kufuneka axhotyiswe ngezixhobo ezibonisa umahluko kuxinzelelo:
Phakathi kwegumbi elicocekileyo negumbi elingacocekanga;
Phakathi kwamagumbi acocekileyo anamanqanaba ahlukeneyo okucoceka komoya
Ngaphakathi kwendawo yemveliso ekumgangatho ofanayo wococeko, kukho amagumbi okusebenzela abaluleke ngakumbi ekufuneka agcine uxinzelelo olubi okanye uxinzelelo oluhle;
Isitshixo somoya kwigumbi elicocekileyo lezinto eziphathekayo kunye nesitshixo somoya esinoxinzelelo okanye esinoxinzelelo olubi ukuthintela ukuhamba komoya phakathi kwamagumbi okutshintshela amanqanaba ahlukeneyo ococeko kwigumbi elicocekileyo labasebenzi;
Izixhobo zoomatshini zisetyenziselwa ukuthutha rhoqo izinto zingena kwaye ziphuma kwigumbi elicocekileyo.
Amagumbi alandelayo acocekileyo kwezonyango kufuneka agcine uxinzelelo olubi xa esetyenziswa kumagumbi acocekileyo kwezonyango akufutshane:
Amagumbi acocekileyo amachiza akhupha uthuli ngexesha lokwenziwa;
Amagumbi acocekileyo amachiza apho kusetyenziswa khona izinyibilikisi zendalo kwinkqubo yemveliso;
Amagumbi acocekileyo kwezonyango avelisa inani elikhulu lezinto eziyingozi, iigesi ezishushu nezifumileyo kunye namavumba ngexesha lenkqubo yokuvelisa;
Amagumbi okucoca, okomisa kunye nokupakisha iipenicillins kunye nezinye iziyobisi ezikhethekileyo kunye namagumbi okupakisha awo ukuze kulungiselelwe.
Ishishini lezonyango nezempilo
"Iinkcukacha zoBugcisa zoKwakha amaSebe otyando olucocekileyo lweZibhedlele" zichaza oku:
● Phakathi kwamagumbi acocekileyo adibeneyo anamanqanaba ahlukeneyo ococeko, amagumbi anococeko oluphezulu kufuneka agcine uxinzelelo oluhle kumagumbi anococeko oluphantsi. Umahluko omncinci woxinzelelo oluzinzileyo kufuneka ube mkhulu okanye ulingane ne-5Pa, kwaye umahluko omkhulu woxinzelelo oluzinzileyo kufuneka ube ngaphantsi kwe-20Pa. Umahluko woxinzelelo akufuneki ubangele umlozi okanye uchaphazele ukuvulwa kocango.
● Kufuneka kubekho umahluko ofanelekileyo woxinzelelo phakathi kwamagumbi acocekileyo adibeneyo anezinga elifanayo lococeko ukuze kugcinwe icala elifunekayo lokuhamba komoya.
● Igumbi elingcoliswe kakhulu kufuneka ligcine uxinzelelo olubi kumagumbi adibeneyo akufutshane, kwaye umahluko omncinci woxinzelelo oluzinzileyo kufuneka ube mkhulu okanye ulingane ne-5Pa. Igumbi lokusebenza elisetyenziselwa ukulawula usulelo oluphuma emoyeni kufuneka libe ligumbi lokusebenza loxinzelelo olubi, kwaye igumbi lokusebenza loxinzelelo olubi kufuneka ligcine umahluko woxinzelelo olubi ungaphantsi kancinci kune-"0" kwi-mezzanine yobugcisa eluphahleni lwayo oluxhonyiweyo.
● Indawo ecocekileyo kufuneka igcine uxinzelelo oluhle kwindawo engacocekanga edibene nayo, kwaye umahluko omncinci woxinzelelo oluzinzileyo kufuneka ube mkhulu okanye ulingane ne-5Pa.
Ishishini lokutya
"Iinkcukacha zobugcisa zokwakhiwa kwamagumbi acocekileyo kwishishini lokutya" zithi:
● Umahluko woxinzelelo olungaguqukiyo we-≥5Pa kufuneka ugcinwe phakathi kwamagumbi acocekileyo adibeneyo kunye naphakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga. Indawo ecocekileyo kufuneka igcine umahluko woxinzelelo oluhle we-≥10Pa ngaphandle.
● Igumbi apho ungcoliseko lwenzeka khona kufuneka ligcinwe kuxinzelelo oluphantsi. Amagumbi aneemfuno eziphezulu zokulawula ungcoliseko kufuneka agcine uxinzelelo oluphantsi.
● Xa umsebenzi wokuhamba komoya ufuna ukuvula umngxuma eludongeni lwegumbi elicocekileyo, kuyacetyiswa ukuba kugcinwe ukuhamba komoya kwicala elingaphambili emngxunyeni ukusuka ecaleni kunye nenqanaba eliphezulu legumbi elicocekileyo ukuya kwicala elingezantsi legumbi elicocekileyo ngomngxuma. Isantya somoya esiqhelekileyo sokuhamba komoya emngxunyeni kufuneka sibe yi-≥ 0.2m/s.
Ukuveliswa ngokuchanekileyo
① "Ikhowudi yoYilo lweGumbi lokuCoca iShishini le-elektroniki" ikhomba ukuba umahluko othile woxinzelelo oluzinzileyo kufuneka ugcinwe phakathi kwegumbi elicocekileyo (indawo) kunye nendawo ejikelezileyo. Umahluko woxinzelelo oluzinzileyo kufuneka uhlangabezane nale migaqo ilandelayo:
● Umahluko phakathi koxinzelelo olungashukumiyo phakathi kwegumbi ngalinye elicocekileyo (indawo) kunye nendawo ejikelezileyo kufuneka umiselwe ngokweemfuno zenkqubo yokuvelisa;
● Umahluko woxinzelelo olungaguqukiyo phakathi kwamagumbi acocekileyo (iindawo) amanqanaba ahlukeneyo kufuneka ube mkhulu okanye ulingane ne-5Pa;
● Umahluko phakathi koxinzelelo oluzinzileyo phakathi kwegumbi elicocekileyo (indawo) kunye negumbi elingacocekanga (indawo) kufuneka libe ngaphezulu kwe-5Pa;
● Umahluko phakathi koxinzelelo oluzinzileyo phakathi kwegumbi elicocekileyo (indawo) kunye nendawo yangaphandle kufuneka ube ngaphezulu kwe-10Pa.
② "Ikhowudi yoYilo lweGumbi elicocekileyo" ichaza oku:
Umahluko othile woxinzelelo kufuneka ugcinwe phakathi kwegumbi elicocekileyo (indawo) kunye nendawo ejikelezileyo, kwaye umahluko woxinzelelo olulungileyo okanye olubi kufuneka ugcinwe ngokweemfuno zenkqubo.
Umahluko woxinzelelo phakathi kwamagumbi acocekileyo amanqanaba ahlukeneyo akufuneki ube ngaphantsi kwe-5Pa, umahluko woxinzelelo phakathi kweendawo ezicocekileyo neendawo ezingacocekanga akufuneki ube ngaphantsi kwe-5Pa, kwaye umahluko woxinzelelo phakathi kweendawo ezicocekileyo nezangaphandle akufuneki ube ngaphantsi kwe-10Pa.
Umoya woxinzelelo olwahlukileyo ofunekayo ukugcina amaxabiso ahlukeneyo oxinzelelo kwigumbi elicocekileyo kufuneka umiselwe yindlela yokuthunga okanye indlela yokutshintsha umoya ngokweempawu zegumbi elicocekileyo.
Ukuvulwa nokuvalwa komoya ohambisayo kunye neenkqubo zokukhupha umoya kufuneka kudityaniswe. Kwindlela efanelekileyo yokucoca igumbi, kufuneka kuqalwe ifeni yokuhambisa umoya, emva koko kuqalwe ifeni yomoya ebuyayo kunye nefeni yokukhupha umoya; xa kuvalwa, indlela yokuvala kufuneka iguqulwe. Inkqubo yokuvala igumbi elinoxinzelelo olubi kufuneka ihambelane nale ingasentla kumagumbi acocekileyo ngoxinzelelo olulungileyo.
Kumagumbi acocekileyo angasebenzi rhoqo, unikezelo lomoya emsebenzini lunokulungiswa ngokweemfuno zenkqubo yokuvelisa, kwaye kufuneka kwenziwe ukucoca umoya.
Ixesha lokuthumela: Septemba-19-2023