I-Biopharmaceuticals ibhekisela kumayeza avelisiweyo kusetyenziswa i-biotechnology, njengamalungiselelo e-biological, iimveliso ze-biological, iziyobisi ze-biological, njl. Ekubeni ubunyulu, umsebenzi kunye nokuzinza kwemveliso kufuneka kuqinisekiswe ngexesha lokuveliswa kwe-biopharmaceuticals, iteknoloji yegumbi elicocekileyo kufuneka isetyenziswe kwinkqubo yokuvelisa ukuqinisekisa umgangatho wemveliso kunye nokhuseleko. Uyilo, ukwakhiwa kunye nokusebenza kwe-biopharmaceutical GMP igumbi elicocekileyo lifuna ukuthotyelwa ngokungqongqo kunye neenkcukacha ze-GMP, kubandakanywa nokulawulwa kwegumbi elicocekileyo lokucoceka komoya, ubushushu, umswakama, ukuhlukana koxinzelelo kunye nezinye iiparitha, kunye nokulawulwa kwabasebenzi, izixhobo, izixhobo kunye nenkunkuma kwigumbi elicocekileyo. Kwangaxeshanye, ubuchwephesha begumbi elicocekileyo eliphambili kunye nezixhobo, ezifana nesihluzi se-hepa, ishawa yomoya, ibhentshi ecocekileyo, njl.
Uyilo lwegumbi elicocekileyo le-gmp lamayeza
1. Uyilo lwegumbi olucocekileyo alukwazi ukuhlangabezana neemfuno zangempela zemveliso. Kwiiprojekthi zamagumbi amatsha acocekileyo okanye iiprojekthi ezinkulu zokulungiswa kwegumbi elicocekileyo, abanini ngokubanzi badla ngokuqesha amaziko ayilo asesikweni ukuba ayilwe. Kwiiprojekthi zamagumbi amancinci naphakathi, ngokuqwalasela iindleko, Umnini ngokuqhelekileyo uya kusayina isivumelwano kunye nenkampani yobunjineli, kwaye inkampani yobunjineli iya kuba noxanduva lomsebenzi woyilo.
2. Ukubhidanisa injongo yovavanyo lwegumbi elicocekileyo, uvavanyo lwentsebenzo yegumbi elicocekileyo kunye nomsebenzi wovandlakanyo linyathelo eliyimfuneko kakhulu lokulinganisa ukuba ngaba iimfuno zoyilo ziyafezekiswa (uvavanyo lokuvuma) nokuqinisekisa ubume obuqhelekileyo bokusebenza begumbi elicocekileyo (uvavanyo lwarhoqo) xa ukwakhiwa kwegumbi elicocekileyo kugqityiwe. Uvavanyo lokuvuma lubandakanya izigaba ezibini: ukugqitywa kokugunyaziswa kunye novavanyo olubanzi lwentsebenzo ebanzi yegumbi elicocekileyo.
3. Iingxaki ekusebenzeni kwegumbi elicocekileyo
①Umgangatho womoya awukho kumgangatho
②Ukusebenza ngokungaqhelekanga kwabasebenzi
③Ugcino lwezixhobo aluloxesha
④Ukucoca okungaphelelanga
⑤Ukulahlwa kwenkunkuma ngokungafanelekanga
⑥Impembelelo yeemeko zokusingqongileyo
Kukho iiparitha ezininzi ezibalulekileyo ekufuneka uzithathele ingqalelo xa uyila igumbi le-GMP elicocekileyo lamayeza.
1. Ucoceko lomoya
Ingxaki yendlela yokukhetha ngokuchanekileyo iiparamitha kwiworkshop yeemveliso zobugcisa. Ngokweemveliso ezahlukeneyo zobugcisa, ukukhetha ngokuchanekileyo iiparamitha zoyilo ngumba osisiseko kuyilo. I-GMP ibeka phambili izikhombisi ezibalulekileyo, oko kukuthi, amanqanaba ococeko lomoya. Itheyibhile elandelayo ibonisa amanqanaba okucoceka komoya achazwe kwilizwe lam le-GMP ye-1998: Ngelo xesha, i-WHO (i-World Health Organization) kunye ne-EU (i-European Union) zombini zineemfuno ezahlukeneyo kumanqanaba okucoceka. . La manqanaba angasentla abonise ngokucacileyo inani, ubungakanani, kunye nemeko yamasuntswana.
Ingabonwa ukuba ukucoceka kothuli oluphezulu luphantsi, kwaye ukucoceka koxinzelelo oluphantsi lothuli luphezulu. Inqanaba lokucoceka komoya luphawu oluphambili lokuvavanya indawo ecocekileyo yomoya. Umzekelo, umgangatho we-300,000-level uvela kwinkcazo entsha yokupakisha ekhutshwe yi-Medical Bureau. Okwangoku akufanelekile ukusetyenziswa kwinkqubo yemveliso ephambili, kodwa isebenza kakuhle xa isetyenziswe kumagumbi athile ancedisayo.
2. Utshintshiselwano lomoya
Inani leenguqu zomoya kwi-air-conditioning system jikelele yi-8 kuphela ukuya kwi-10 ngamaxesha ngeyure, ngelixa inani lokutshintsha komoya kwindawo ecocekileyo yoshishino ngamaxesha angama-12 kwinqanaba eliphantsi kunye namaxesha angamakhulu amaninzi kwinqanaba eliphezulu. Ngokucacileyo, umahluko kwinani lotshintsho lomoya lubangela umthamo womoya Umahluko omkhulu ekusebenziseni amandla. Kuyilo, ngesiseko sokubeka ngokuchanekileyo ukucoceka, amaxesha aneleyo okutshintshana komoya kufuneka aqinisekiswe. Ngaphandle koko, iziphumo zokusebenza aziyi kuba kumgangatho, amandla okuthintela ukuphazamiseka kwegumbi elicocekileyo aya kuba mbi, amandla okuzihlambulula aya kwandiswa ngokuhambelanayo, kwaye uchungechunge lweengxaki luya kuba ngaphezu kweenzuzo.
3. Umahluko woxinzelelo oluzinzileyo
Kukho uluhlu lweemfuno ezifana nomgama phakathi kwamagumbi acocekileyo amanqanaba ahlukeneyo kunye namagumbi angacocekanga awakwazi ukuba ngaphantsi kwe-5Pa, kwaye umgama phakathi kwamagumbi acocekileyo nangaphandle awukwazi ukuba ngaphantsi kwe-10Pa. Indlela yokulawula umahluko we-static yoxinzelelo kukubonelela ngomthamo othile womoya woxinzelelo olulungileyo. Izixhobo zoxinzelelo olulungileyo oluqhele ukusetyenziswa kuyilo ziivalvu zoxinzelelo olushiyekileyo, ii-different pressure volume regulators zombane kunye neeleya zokudambisa umoya ezifakwe kwiindawo zokubuya zomoya. Kwiminyaka yakutshanje, indlela yokungafaki isixhobo soxinzelelo olulungileyo kodwa ukwenza umthamo womoya wonikezelo ube mkhulu kunomthamo womoya wokubuya kunye nokukhupha umthamo womoya ngexesha lokugunyaziswa kokuqala kudla ngokusetyenziswa kuyilo, kwaye inkqubo yolawulo oluzenzekelayo ehambelana nayo inokufezekisa umphumo ofanayo.
4. Umbutho wokuhamba komoya
Ipateni yombutho womoya wegumbi elicocekileyo yinto ephambili ekuqinisekiseni umgangatho wococeko. Ifom yentlangano ye-airflow ehlala yamkelwa kuyilo lwangoku inqunywe ngokusekelwe kwinqanaba lokucoceka. Ngokomzekelo, iklasi ye-300,000 igumbi elicocekileyo lihlala lisebenzisa i-top-feed kunye ne-top-return-airflow, iklasi ye-100000 kunye neklasi ye-10000 yokuyila i-cleanroom designs ngokuqhelekileyo isebenzisa i-airflow ephezulu kunye ne-low-side return airflow, kwaye amagumbi acocekile aphezulu asebenzisa ukuhamba okuthe tye okanye okuthe nkqo unidirectional.
5. Ubushushu kunye nokufuma
Ukongeza kwitekhnoloji ekhethekileyo, ukusuka kumbono wokufudumeza, ukungena komoya kunye ne-air conditioning, ngokukodwa igcina induduzo yabaqhubi, oko kukuthi, ukushisa okufanelekileyo kunye nomswakama. Ukongezelela, kukho izikhombisi ezininzi ezimele zitsale ingqalelo yethu, ezifana nesantya somoya we-cross-sectional we-tuyere duct, ingxolo, isantya somoya we-cross-sectional we-tuyere duct, ingxolo, ukukhanya, kunye nomlinganiselo womthamo womoya omtsha, njl. Le miba ayinakungahoywa kuyilo. qwalasela.
Uyilo lwegumbi elicocekileyo le-Biopharmaceutical
Amagumbi acocekileyo ebhayoloji ahlulwe kakhulu abe ziindidi ezimbini; amagumbi acocekileyo ebhayoloji kunye nokhuseleko lwebhayoloji amagumbi acocekileyo acocekileyo. Abaqulunqi bobunjineli be-HVAC bahlala bevezwa ngaphambili, eyona nto ilawula ukungcoliseka komsebenzi ngamasuntswana aphilayo. Ukuya kumlinganiselo othile, ligumbi elicocekileyo lemizi-mveliso elongeza iinkqubo zokuvala inzala. Kumagumbi acocekileyo oshishino, kuyilo lobuchwephesha benkqubo ye-HVAC, indlela ebalulekileyo yokulawula inqanaba lokucoceka kukuhluza kunye noxinzelelo oluhle. Kumagumbi acocekileyo ebhayoloji, ukongeza ekusebenziseni iindlela ezifanayo njengamagumbi acocekileyo akwimizi-mveliso, kuyafuneka ukuba kuthathelwe ingqalelo umba wokhuseleko lwebhayoloji. Ngamanye amaxesha kuyimfuneko ukusebenzisa uxinzelelo olubi ukuthintela iimveliso ekungcoliseni indalo.
Ixesha lokuposa: Dec-25-2023