I-OEB5 I-Oncology ye-Oncology Vial City
I-Iven pharmatechNgumthengisi wobuvulindlela wezityalo ze-Studingy ezibonelela ngesisombululo senjineli esihlanganisiweyo soMzi-mveliso wase-IV ofana nesisombululo se-IV, isitofu sokugonya, i-Oncology njl njl, i-US FDA CMMP, i-fecs ye-US.
Sinikezela ngowona uyilo lweprojekthi olusengqiqweni, izixhobo ezisemgangathweni kunye nenkonzo eyakhiwe ngokwezixhobo ezahlukeneyo kunye ne-IT ye-IV ye-IT ye-IV, i-GP ye-IV ye-IV, i-Ampoupe, ityhubhu yegazi, ityhubhu yegazi, ityhubhu yegazi.
Ithini i-Iven Active Taial vial vial vial vial vial vial rating ibandakanya:
I-Inshoring ye-Inven ye-Iven ye-Iven yeFowuni ye-Encology eNgcolileyo iquka igumbi elicocekileyo, inkqubo yokuhambisa amanzi, i-vial yokusasaza, inkqubo yokuhambisa amanzi, iLebhu yokuLawula imigangatho, iLebhu ephakathi kunye ne-Nt. njl. Njl. Izinto ezifunekayo kubathengi
I-1.Inza i-Oncology Vial Vial Vial Vial-Ukuzibulala kunye ne-tollyrogenation-ukugcwalisa - ukumisa - i-capping-i-capping-intambo yokuhlamba intambo yangaphandle:
Lo mgca usetyenziselwa ukuvelisa i-Vials eqingqiweyo ye-Oncology, equka oomatshini abayi-5: i-servo egcweleyo eqhutywa nkqo i-Ultrasosonic Home, i-rion ye-versogen evuthayo kunye nomatshini wokugcwala kwe-vial, umatshini wokumisa ophumeleleyo we-vial, umatshini wokuhlamba we-vial.
Emva kokugcwalisa, iya kuya e-Semi-Diating kwaye ilungele ukomisa umatshini, emva koko uye kumatshini wokuthumela, emva koko, iya kumatshini wokuhlamba wangaphandle. Simkele inkqubo yobunzima be-intanethi yokugcwalisa umatshini wokugcwalisa, iimveliso ezingalunganga ziya kukhatywa ngokuzenzekelayo.
1. Ukuhlamba
I-2. Ukubulala i-Destilines
3. Ukuzalisa kunye nokuyeka
I-4. Ikhephu
5. Ukuhlamba kwangaphandle
6. Igqityiwe
I-2FreeE slorter kunye nokulayisha ngokuzenzekelayo kunye nokulayisha inkqubo:
Kwiimveliso zeLoophil, emva kokugcwalisa kwaye kunqanyulwe ukukhulula i-Free Staf (Liophilizer) ngokuzenzekelayo ngenkqubo yokulayisha ngokuzenzekelayo, emva kwe-LOOPICATER, iya kudluliselwa kumatshini wokufaka i-Auto-I-Auto-Commang Sysurang Sysurs Sysuning Systems.
Inkqubo yokuThumela:
Njengoko i-oncoglogy yimveliso enetyhefu, sinokuxhobisela i-isolator ukugcina ukhuseleko lwabasebenzi kwiimveliso, ukuqinisekisa ukuba inkqubo yemveliso ikhuselwe ngokupheleleyo kwinkqubo yokungasebenzi.
Intshayelelo emfutshane
I-1.operator ihlulekile ngokupheleleyo kwindawo yemveliso ephambili ye-Stele.
I-2.A yenqanaba lemveliso yangaphakathi. C / D Igumbi langaphandle elicocekileyo.
3.Ukuvula i-ISHOATOR emva kokuvalwa kwenkqubo, ukuqinisekiswa kubalulekile ukuze uqalise kwakhona.
4.CustomIz ye-HPVs ye-steriliza yangaphakathi.
Inkqubo yokujikeleza kwenziwe.
I-6.Adop ye-hepa yomoya, i-membrane inokukhusela ukuhamba komoya kunye nefilitha.
Isakhiwo sangaphakathi esingasasebenziyo, uyilo lokujikeleza.
8.Adopt itywina elinemikhono yeminyango evulekileyo kunye neefestile zegloves.
9. Imveliso yetyhefu, sebenzisa uyilo lwegqwirha kwingxowa.
Eminye imisebenzi
I-1.CCIP / Inkqubo ye-SPIP (i-SIP yi-VHP).
2.Pargaricle i-overper kwi-intanethi.
I-3.Airborne esebenzayo.
4. I-Hydrogen Dydrogen Dioxide generator.
5.Ukuguqula i-glove yegloves.
6.Ane -anemometer.
I-7.H / T Sensor.
8.Umgangatho wokulinganisa.
Imodyuli yovavanyo lwe-9
Isixhobo seSandisi se-10.Air.
11.Bhala-icebo lokucoca i-11
Inkqubo yeNkqubo:
Ingayigqiba i-vial ye-vial vial oncology ekhanyayo yokuhlola, ilebheli, i-blister enepaki yebhokisi eyintloko, kunye nokuhambisa ibhokisi yokupakisha.
Sinokuxhobisa nge-carton yokuvula ngokuzenzekelayo, incwadana yemiyalelo kunye nokupakishwa kwe-Carton, ibhokisi yokutywina, ibhokisi ye-Carton, inkqubo yokwamkelwa kwedatha, kunye nelebheli engenasisindo, okanye ezona zelebheli engenasiphelo.
I-5.Unyango lwamanzi amaninzi:
Ibandakanya unyango olucocekileyo (2ro + e-Eda), i-diviller yamanzi (i-WFI), kunye noMvelisi weSteam ococekileyo. Itanki ye-PW kunye ne-WFI Tank ibandakanyiwe.
Igumbi le-6.Clean & HVAC
Kubandakanya iiphaneli zodonga zegumbi ezicocekileyo, iiphaneli zentsholongwane, iiwindows, iminyango, indawo yokuphamba, i-hipa ye-Air, inkqubo yokulawula i-Oncology.
7.Black intombi
Kubandakanya inkqubo ye-compressor ye-air compressor kunye nenkqubo ye-Boiler ukubonelela ngomoya ofanelekileyo kunye ne-steam yemveliso ye-vial ye-oncology ye-Oncology.
8.Kla
Ibandakanya zonke iintlobo zezixhobo zokuvavanya iilebhu, kunye nefanitshala yelebhu yokuvavanya iisampulu ze-vial ze-vial ze-vial kunye nezixhobo eziluhlaza, i-HIPC, i-Atoviolet SpectRomar Spectrometer, i-SEERMICE Spectrometer Spectrometer,
9.Dimanisayo kunye nenkqubo yepayitha
Ibandakanya zonke iintlobo ze-piidiel yenkqubo kunye nombhobho womzi-mveliso ofunekayo kwisityalo esingafunekiyo se-vial socology, njengamanzi acocekileyo, amanzi, amanzi acocekileyo, umzi ocinezelweyo, umzi mveliso, umzi wezamashishini.
IvenYiba neqela lezobuchwephesha kwezobugcisa kunye nezobunjineli, uqeqesho lwethu lwe-Onsite kunye nenkxaso yasemva kwentengiso inokunika isiqinisekiso sexesha elide sobuchwephesha kwi-PVC ye-PVC ye-ATV
Uluhlu olupheleleyo lwamaxwebhu lunokukunceda ukuba ufumaneI-GMP kunye neSitifiketi seFDAKwisityalo senu sesityalo (kubandakanywa i-IQ / OQ / PQ / DQ / DQ / IFAY / Sat njl):
Umsebenzi we-Iventi kunye namava kunokukunceda ugqibezele isisombululo se-IV ye-IV kwixesha elifutshane kwaye uphephe zonke iintlobo zomngcipheko:
IvenYiba neqela lezobuchwephesha kwezobugcisa kunye nezobunjineli, uqeqesho lwethu lwe-Onsite kunye nenkxaso yasemva kwentengiso inokunika isiqinisekiso sexesha elide sobuchwephesha kwi-PVC ye-PVC ye-ATV
Ukuza kuthi ga ngoku, sele sinike uninzi lweeseti zamakhulu ezixhobo zamachiza kunye nezixhobo zonyango ukuya kumazwe angaphezu kwama-50.
Ngeli xesha, sanceda abathengi bethu ukubaYakhe eyakhe i-20 + yezityalo ze-sullical kunye nezonyangoE-Uzbekistan, Tajikistan, Indonesia, Thailand, Saudi, I-Nigeria, eUgania, Tanzia, eMyanmar njl njl. Zonke ezi projekthi ziphumelele abathengi bethu kunye norhulumente ophambili.
Siphinde sathumela umgca wokuvelisa isisombululo se-IV kwiJamani.
IV Botle yeBhotle
I-Vietnam iv ibhotile ibhotile ibhotile
IV ye-Uzbekistan iv ibhotile ibhotile
I-Thailand ayinasityalo esingaqhelekanga
I-Tajikististan iv ibhotile ibhotile
