I-ISO 7 gmp yegumbi elicocekileyo

Inkcazo emfutshane:

Ngaphezulu kweminyaka engama-20 kumava acocekileyo kwigumbi elicocekileyo, siqulethe amatyala aphesheya kwihlabathi liphela. Singabonelela ngenkonzo yokumisa enye yokucwangciswa kokusebenza kokuqala kokusebenza kwegumbi lakho le-ESMAYICATION ngokwe-ISO STATE ye-ISO 14644, i-GMP, i-GDA, i-vem.

Thumela i-imeyile kuthi

Iinkcukacha zemveliso

Iimpawu zeMveliso

Ingcaciso yeMveliso

Igumbi elicocekileyo lamayeza ikakhulu lisetyenziswa ikakhulu kwi-ostints, eqinileyo, isiraphu, iseti, njl njl. Ithagethi kukwakha imeko yegumbi lesayensi kunye nendawo ecocekileyo, inkqubo, yokusebenza kunye nenkqubo yolawulo kwaye isuse kakhulu i-themitor enokubakho kunye nemveliso enqamlezileyo kunye nemveliso yeziyobisi ecocekileyo. Kufuneka ugxile kwinqanaba eliphambili lolawulo lokusingqongileyo kwaye usebenzise itekhnoloji yogcino lwamandla njengoko inketho. Xa ekugqibeleni iqinisekisiwe kwaye ifanelekile, kufuneka ivunywe kutyalo lokutya lwasekhaya kunye neziyobisi kuqala ngaphambi kokubekwa kwimveliso. Itekhnoloji ye-GMP yeGumbi yeGumbi yeGumbi yeGuzi le-GMP yeGumbi yeGunya kunye neTekhnoloji yoLawulo loNgcoliseko yenye yeyona ndlela iphambili yokuqinisekisa ukuphunyezwa ngempumelelo kwe-GMP. Njengomnikezeli wegumbi lokucoca igumbi lokucoca igumbi lokucoca igumbi, sinokubonelela ngenkonzo ye-GMP yokumisa ukusuka ekucwangcisweni kokugqibela njengokuhamba kwegumbi, igumbi lokuhlambela igumbi, igumbi lokucoca igumbi, inkqubo yokuhlola igumbi lokucoca igumbi , inkqubo ye-piidiel, kunye nezinye iinkonzo zokuxhasa ukufakelwa, njl njl.

Iphepha ledatha lobugcisa

Iklasi ye-ISO	I-max sunt / m3				I-bacteria edadayo / m3	Ifakwe i-bacteria (Ø900mm) CFU / 4h	I-microorganism yomphezulu
	I-Static State		I-Dynamic State				Chukumisa (Ø55mm) cf / dish	Iigloves ezi-5 zeminwe ze-CFU / iigloves
	≥0.5 μm	≥5.0 μm	≥0.5 μm	≥5.0 μm			Chukumisa (Ø55mm) cf / dish	Iigloves ezi-5 zeminwe ze-CFU / iigloves
ISO 5	I-3520	20	I-3520	20	<1	<1	<1	<1
ISO 6	I-3520	29	352000	2900	10	5	5	5
ISO 7	352000	2900	3520000	29000	I-100	50	25	/
ISO 8	3520000	29000	/	/	200	I-100	50	/

Iinkcukacha zemveliso

Ulwakhiwo Icandelo
• Igumbi lokucoca igumbi kunye nephaneli yophahla
• Igumbi lokucoca igumbi kunye nefestile
• Ukucoca iprofayili ye-ROM kunye ne-hanger
Umgangatho we-Epoxy

Inxalenye ye-HVAC
Iyunithi yokuphatha umoya
• Khuphela i-Inlet yomoya kunye kwaye ubuyisele ngaphandle
• I-duct yomoya
• Izixhobo zokuthambisa

Icandelo lombane
Ukucoca igumbi lokucoca
• Tshintshela kunye nesokethi
• Intambo kunye nentambo
Ibhokisi yokuhambisa amandla

Inxalenye yolawulo
Ukucoceka komoya
• Iqondo lokushisa kunye nokufuma ngokuhambelana
•Ukuhamba komoya
• Ingcinezelo eyahlukileyo

Izisombululo zeSpeckey

UCwangciso
Singabonelela ngeengcebiso zobungcali
kunye nesisombululo sezoBunjineli.

Imveliso kunye nokuHanjiswa
Singabonelela ngemveliso esemgangathweni ephezulu
Kwaye ukuhlolwa ngokupheleleyo ngaphambi kokuhanjiswa.

Ufakelo kunye nokugunyazisa
Singanika amaqela phesheya
Ukuqinisekisa ukusebenza ngempumelelo.

Ukuqinisekiswa kunye noQeqesho
Singabonelela ngeempahla zokuvavanywa
fezekise umgangatho oqinisekisiweyo.

Ngathi

• ngaphezulu kweminyaka engama-20, edityaniswe ne-R & D, uyilo, ukuvelisa kunye nokuthengisa;

• abathengi abangaphezulu kwe-200 kumazwe angaphezu kwama-60;

Ukugunyaziswa yi-ISO 9001 kunye ne-ISO 14001 yolawulo.

• Umnikezeli wePhepha lePhambili yePhepha leShedy project;

Inkonzo yokumisa enye ukusuka kuyila lokuqala lokusebenza;

• Imimandla emi-6 efana nezamachiza, elebhu, elektroniki, isibhedlele, isixhobo, isixhobo sonyango, njl.njl.

• Ukucoceka kwegumbi lokucoca igumbi kunye nomthengisi;

• ufumana amalungelo obunikazi kunye nezatifikethi ze-CE kunye ne-CQC;

• Iimveliso ezi-8 ezifana nephaneli yegumbi elicocekileyo, ucango lwegumbi lokucoca, i-HEPA, i-FFU, ibhokisi ye-FFU, iBhokisi yeBhola, iBhonki ye-Air, njl njl.