Ukuhamba kolwelo akunakwahlulwa kwisiphumo "soxinzelelo loxinzelelo".Kwindawo ecocekileyo, umahluko woxinzelelo phakathi kwegumbi ngalinye ngokumalunga nomoya wangaphandle ubizwa ngokuba "ngumahluko opheleleyo woxinzelelo".Umahluko woxinzelelo phakathi kwegumbi ngalinye elimeleneyo kunye nommandla omeleneyo ubizwa ngokuba "ngumohluko woxinzelelo ohambelanayo", okanye "umahluko woxinzelelo" ngokufutshane.Ukwahlukana koxinzelelo phakathi kwegumbi elicocekileyo kunye namagumbi adibeneyo adibeneyo okanye iindawo ezijikelezileyo ziyindlela ebalulekileyo yokugcina ukucoceka kwangaphakathi okanye ukunciphisa ukusasazeka kwezinto ezingcolileyo zangaphakathi.Imizi-mveliso eyahlukeneyo ineemfuno ezahlukeneyo zokwahluka koxinzelelo kumagumbi acocekileyo.Namhlanje, siza kwabelana nawe ngeemfuno zomahluko woxinzelelo kwiinkcukacha ezininzi eziqhelekileyo zegumbi elicocekileyo.
Ishishini lamachiza
①I "Imveliso elungileyo yoMveliso yeeMveliso zaMayeza" ichaza: Umahluko woxinzelelo phakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga kwaye phakathi kweendawo ezahlukeneyo ezicocekileyo akufanele zibe ngaphantsi kwe-10Pa.Xa kuyimfuneko, ii-gradients zoxinzelelo ezifanelekileyo kufuneka kwakhona zigcinwe phakathi kweendawo ezahlukeneyo zokusebenza (amagumbi okusebenza) kwinqanaba elifanayo lokucoceka.
②I-"Veterinary Drug Manufacturing Practice Good Manufacturing Practice" ichaza: Umahluko we-static woxinzelelo phakathi kwamagumbi akufutshane acocekileyo (iindawo) ezinamaqondo ahlukeneyo ococeko lomoya kufuneka ube mkhulu kune-5 Pa.
Umahluko woxinzelelo lwe-static phakathi kwegumbi elicocekileyo (indawo) kunye negumbi elingacocekanga (indawo) kufuneka libe likhulu kune-10 Pa.
Umahluko wexinzelelo lwe-static phakathi kwegumbi elicocekileyo (indawo) kunye ne-atmosphere yangaphandle (kubandakanywa neendawo ezixhunywe ngokuthe ngqo ngaphandle) kufuneka zibe mkhulu kune-12 Pa, kwaye kufuneka kubekho isixhobo sokubonisa ukuhluka koxinzelelo okanye inkqubo yokubeka iliso kunye ne-alamu.
Kwiindibano zocweyo zamagumbi ezicocekileyo zeemveliso zebhayoloji, ixabiso elipheleleyo lomahluko omileyo woxinzelelo oluxelwe ngasentla kufuneka umiselwe ngokweemfuno zenkqubo.
③ "IMigangatho yoYilo lweGumbi eliCocekileyo kwi-Pharmaceutical" ichaza: Umahluko woxinzelelo lwe-air static phakathi kwamagumbi acocekileyo onyango anamanqanaba ahlukeneyo okucoceka komoya naphakathi kwamagumbi acocekileyo kunye namagumbi angacocekanga akufuneki abe ngaphantsi kwe-10Pa, kunye noxinzelelo olusisigxina phakathi kwamagumbi acocekileyo onyango kunye umoya wangaphandle akufanele ube ngaphantsi kwe-10Pa.
Ukongeza, la magumbi alandelayo acocekileyo amayeza kufuneka axhotyiswe ngezixhobo ezibonisa umahluko woxinzelelo:
Phakathi kwegumbi elicocekileyo kunye negumbi elingacocekanga;
Phakathi kwamagumbi acocekileyo anamanqanaba ahlukeneyo okucoceka komoya
Kwindawo yemveliso ekumgangatho ofanayo wococeko, kukho amagumbi otyando abaluleke ngakumbi ekufuneka agcine uxinzelelo olubi okanye uxinzelelo olulungileyo;
Isitshixo somoya kwindawo ecocekileyo yezinto kunye noxinzelelo oluhle okanye uxinzelelo olubi lokuvala umoya ukuvala ukuhamba komoya phakathi kwamagumbi okutshintsha amanqanaba ahlukeneyo okucoceka kwigumbi elicocekileyo labasebenzi;
Iindlela zoomatshini zisetyenziselwa ukuthutha izinto ngokuqhubekayo ngaphakathi nangaphandle kwegumbi elicocekileyo.
La magumbi alandelayo acocekileyo kwezonyango kufuneka agcine uxinzelelo olubi olunxulumene namagumbi akufutshane acocekileyo onyango:
amagumbi acocekileyo amayeza akhupha uthuli ngexesha lemveliso;
amagumbi acocekileyo amayeza apho i-solvents eziphilayo zisetyenziselwa inkqubo yokuvelisa;
Amagumbi acocekileyo onyango avelisa isixa esikhulu sezinto eziyingozi, iigesi ezishushu nezinomswakama kunye nezivumba ngexesha lenkqubo yokuvelisa;
Ukusulungekiswa, ukomisa kunye namagumbi okupakisha iipenicillins kunye namanye amayeza akhethekileyo kunye namagumbi azo okupakisha ukulungiselela.
Ishishini lezonyango kunye nezempilo
"IiNgcaciso zobuGcisa zoKwakha amaSebe oTyando oluCocekileyo eZibhedlele" ichaza:
● Phakathi kwamagumbi acocekileyo adityanisiweyo anamanqanaba ahlukeneyo okucoceka, amagumbi anococeko oluphezulu kufuneka agcine uxinzelelo olulungileyo kumagumbi anococeko oluphantsi.Ubuncinci be-static umahluko woxinzelelo kufuneka ube mkhulu okanye ulingane ne-5Pa, kwaye umahluko omkhulu woxinzelelo lwe-static kufuneka ube ngaphantsi kwe-20Pa.Ukwahlukana koxinzelelo akufanele kubangele impempe okanye kuchaphazele ukuvulwa kocango.
● Kufuneka kubekho umahluko ofanelekileyo woxinzelelo phakathi kwamagumbi acocekileyo adityanisiweyo akumgangatho ofanayo wococeko ukugcina icala elifunekayo lokuhamba komoya.
● Igumbi elingcoliseke kakhulu kufuneka ligcine uxinzelelo olubi kumagumbi adityanisiweyo akufutshane, kwaye umahluko omncinci we-static woxinzelelo kufuneka ube mkhulu okanye ulingane ne-5Pa.Igumbi lotyando elisetyenziselwa ukulawula usulelo oluphuma emoyeni kufuneka libe ligumbi lokusebenza loxinzelelo olungalunganga, kwaye igumbi lokusebenza loxinzelelo olubi kufuneka ligcine umahluko ongalunganga woxinzelelo ongaphantsi kancinane kuno "0" kwi-mezzanine yobugcisa kwisilingi yayo exhonyiweyo.
● Indawo ecocekileyo kufuneka igcine uxinzelelo olulungileyo kwindawo engacocekanga edityaniswe kuyo, kwaye umehluko omncinci we-static kufuneka ube mkhulu okanye ulingane ne-5Pa.
Ishishini lokutya
"IiNgcaciso zobuGcisa zoLwakhiwo lwamagumbi acocekileyo kuShishino lokuTya" ichaza:
● Umahluko we-static pressure ye-≥5Pa kufuneka ugcinwe phakathi kwamagumbi acocekileyo adibeneyo kunye naphakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga.Indawo ecocekileyo kufuneka igcine umahluko oqinisekileyo woxinzelelo lwe-≥10Pa ukuya ngaphandle.
● Igumbi apho ungcoliseko lwenzeka khona kufuneka ligcinwe kuxinzelelo olubi ngokwentelekiso.Amagumbi aneemfuno eziphezulu zolawulo longcoliseko kufuneka agcine uxinzelelo olulungileyo.
● Xa umsebenzi wokuhamba kwemveliso ufuna ukuvula umngxuma eludongeni lwegumbi elicocekileyo, kuyacetyiswa ukuba kugcinwe ukuhamba komoya okuya ngqo kumngxuma ukusuka kwicala elinomgangatho ophezulu wegumbi elicocekileyo ukuya kwicala elisezantsi legumbi elicocekileyo. umngxuma.Umyinge wesantya somoya wokuhamba komoya kumngxuma kufuneka ube ≥ 0.2m/s.
Ukwenziwa ngokuchanekileyo
① "IKhowudi yoYilo lweGumbi loShishino lwe-elektroniki" ikhomba ukuba umahluko othile woxinzelelo oluzinzileyo kufuneka ugcinwe phakathi kwegumbi elicocekileyo (indawo) kunye nendawo ejikelezileyo.Umahluko omileyo woxinzelelo kufuneka uhlangabezane nale migaqo ilandelayo:
● Umahluko we-static yoxinzelelo phakathi kwegumbi ngalinye elicocekileyo (indawo) kunye nendawo ejikelezileyo kufuneka igqitywe ngokweemfuno zenkqubo yokuvelisa;
● Umahluko we-static yoxinzelelo phakathi kwamagumbi acocekileyo (iindawo) zamanqanaba ahlukeneyo kufuneka abe mkhulu okanye alingane ne-5Pa;
● Umahluko woxinzelelo lwe-static phakathi kwegumbi elicocekileyo (indawo) kunye negumbi elingacocekanga (indawo) kufuneka libe likhulu kune-5Pa;
● Umahluko woxinzelelo lwe-static phakathi kwegumbi elicocekileyo (indawo) kunye nangaphandle kufuneka libe likhulu kune-10Pa.
② "Coca iKhowudi yoYilo lweGumbi" imisela:
Umahluko othile woxinzelelo kufuneka ugcinwe phakathi kwegumbi elicocekileyo (indawo) kunye nendawo ejikelezileyo, kwaye umahluko ofanelekileyo okanye ongalunganga woxinzelelo kufuneka ugcinwe ngokweemfuno zenkqubo.
Ukwahlukana koxinzelelo phakathi kwamagumbi acocekileyo amanqanaba ahlukeneyo akufanele kube ngaphantsi kwe-5Pa, ukuhlukana koxinzelelo phakathi kweendawo ezicocekileyo kunye neendawo ezingacocekanga akufanele zibe ngaphantsi kwe-5Pa, kwaye ukuhlukana koxinzelelo phakathi kweendawo ezicocekileyo nangaphandle akufanele kube ngaphantsi kwe-10Pa.
Umoya ohlukeneyo woxinzelelo olufunekayo ukuze kugcinwe amaxabiso ahlukeneyo oxinzelelo loxinzelelo kwigumbi elicocekileyo kufuneka ligqitywe ngendlela yokuthunga okanye indlela yokutshintsha umoya ngokweempawu zegumbi elicocekileyo.
Ukuvulwa kunye nokuvala umoya wokubonelela kunye neenkqubo zokukhupha kufuneka zivalelwe.Kuluhlu oluchanekileyo oludibeneyo oludibeneyo lwegumbi, i-fan yokuhambisa umoya kufuneka iqalwe kuqala, kwaye emva koko i-air fan yokubuya kunye ne-exhaust fan kufuneka iqalwe;xa uvala, ukulandelelana okudibeneyo kufuneka kuguqulwe.Inkqubo edibeneyo yoxinzelelo olubi amagumbi acocekileyo kufuneka achasane nalapha ngasentla kumagumbi acocekileyo acocekileyo oxinzelelo.
Kumagumbi acocekileyo kunye nokusebenza okungaqhubekiyo, ukunikezelwa kwe-air-on-duty kunokusekwa ngokweemfuno zenkqubo yokuvelisa, kunye nokucoca umoya kufuneka kwenziwe.
Ixesha lokuposa: Sep-19-2023