Amagotyeni Okulula Amagotyeni okulula zilungiselela isiqephu esisodwa sokugcina kweSihloko saseMethiso & Isifundo Sokuqala neziqhuthu zikhona ukuba zingaphambili lokusebenzela ngokuphakamisayo imibiko yezinto ezizibophekileyo njengebulali obuchwephesha; amavhakhi wehlangu, iziphetho eziphophazekileyo. Amagotyeni (Okulula) Zinikwe umnikelo wokuba zingaphambili lapho uzokusetyenziswa ukugcina amanye amandla okulula, ezivunyelwe ngokubanzi ukuba lemgotyeni aluhlale ukukholelwa ngeendlu engasenzi kontolo nokuphathelana nokuphatha amagotyeni okulula ngokuphakamisa ukuze usure usesenza isenzo sesiphambili esiphambiliyo nokuvumela amanye amandla asepharmasiya. Ngaba yintoni ukusetshenziswa nokugcina amagotyeni okulula ngokuyaziyo kunye nokuba yintoni umnikelo wokuhlinza okusetyenziswa ngokuba kufanele.
Izicatshulwa zakho ezilondoloziwe zikunjalo kwinani lezinye iindlela, kufuneka uthole ukuba uzihlinzelelwanga wonke amandla apha ukuba azifane kwindawo yokuziphatha ngokuphephandelayo. Izilondolozi zidlule kwi ndawo engasetyenziswa, engasetyenziswa. Leli ndawo alithathe inye into esingazityelwa ngaphandle kokuba ngamandla amandla amalondoloziweyo / umsebenzi.
Inxalenye ngoku ngingene ukuyithetha ngokuba ngaba yintlanganiso ukugcina amathumbu aqhelekileyo. Lokhu kungabangeli phakathi kwezinto ezaziwayo kunye nokusetyenziswa. Kodwa, ngokulandelayo, kubekwa ukuba amathumbu aqhelekileyo akhuselekelwe ngomphoyiso womlilo & akwazi ukufika eziphumleni lokuhlola. Ukuthi oku kuziphindaphinda ukukholela ukusuka komphilo we-sample noma iimbali phakathi kwezithumbu ezahlolakele.
Manje ungazazi lamanzi labe lalayithi zizikhundla ezinikezela ezidinga izinto eziningi kunye nezinye izidluko ezivamileyo ezilandelwe ngemvondo ofanele kunye nenkinga enkulu. Schott AG, Gerresheimer AG, West Pharmaceutical Services, Inc., SGD Pharma baye basebenzisa ngokuphi ndawonye lokushesha lemkhonto wokusetyenziswa kwamathumbu aqhelekileyo. Ngokwesiphi Stryker kunye noDePuy bazibophelele ngendlela yabo ngokungavumelekanga ngezithumbu zakhe.
Umbonisi wesiqephu somthombo wamathumba aqhelekileyo
Amathetho amahlukileyo kwiLab ayithandana nembikha yezinto ezisetyenziswa. Umbikha wesithombo (kubalulekile kulokhu okanye umbhali wesintsho noma amaninzi okanye amasolosheni apha umntu wamaphandle angayazi ukuba ufuna ukugcina ngomoya, engavumelelwe yintlizyo) ngoko ke ithi ingakho esp kwiindlela zokuthetha ezindala nokuthi zikhona imicrobiology. Ukugcina ukufundiswa kunye nomphilo wendlabathi phakathi kwezinto ezisetyenziswa zeSterile Vials
Ukushintsha KweVial Ngemali - Umnotho Wokuxhasa Lwamagqibela Wesithombo Ngenqanawe
Ukuba uqinisekile ukulingana nendawo, qinisekisa futhi gcinisa ukuba kune veyilayithi ezizilinganiswe - uphetho - phambi kokufumaneka. Ngokulungile, kuhlu lokusebenza ngokwesintu kulwa amaxwebhu we-steril baby aziphakamisela ukubuyiselwa ngumthwalo (njenge-EO no gamma irradiation). Umthwalo (amasimu asingaphambili) nokubuyiselwa kwe-EO (igas engavunyelwe i-microorganisms). Ngaphezulu, ukubuyiselwa nge-gamma irradiation kunye nesiXhumanisi esifundekayo ukubuyiselwa. Kune zinto ezininzi ezidingiswa ngabanye abasebenzi xa zikhetha umthetho wokuqinisekiswa, ubuciko obudingeka ukugcina kwaye ungenzi lokuhlola.
Ukukhetha amaninzi okucacileyo kweemayilini ezisetyenzisiweyo kunye nokuba ngaphi umlayezo wokugcinwa olusemva lokhu uhlala ukuba kusukelele (ngakwesiphi ngenxa yokuba, ngazo zonke izinto ezimfanele), eziphumaphi ukuthi siyazi singafika ndawonye xa esebenza naye kunye nokuba yintoni inani leqinisekiso lomoya lokuhlola. Zikhetho ezimbili zifuneka zibhekiseleyo umbhizinisi weemayili efana ne-2 ml noma emayili engasheya elihlanu ml. Ngaparaphu kwedlulintsimbi, ukukhetha komlayezo wesithathu kufuneka kubheke phakathi kwezinto ezizama ukumelwa ngeenkonzo ezichemikali kunye nokuba kungabhediswa ngempumelelo etc.
Izivayile ezisetyenziswa zinale nto yokugcina olunye ulwandle olubanzi olubungxenywa ngokuphakamiswayo ukusurela ukuthi amaservisi akhawulezi amandla kwezinto ezininzi kwi-health, kufanele kuhlola izinto ezinethunywa ezinethunyelwa phakathi nemibhulapha nokuhlola ngendlela eyahlukene yokuhandleni nokugcwalisa leso sonto sokuthi lokhu kudingeka ukuze uhlobo lwenqanawe lolu hluke kulandelwe. Ngokushesha, ukugcina nalendlela lokusebenza kunokungena ngevayile elithileyo kanye nokuba ubani okudingekayo. Ngoko ke, ukugcina nalendlela lokusebenza kunokungena ngevayile elithileyo kunokuba ubani okudingekayo.
Ubuhle ubungene yinto yokuhlola ukusithumela isesha. Ubuncinci obunquma kuloo moya wokuqala kwesikhashana sokuhlola amaviala ezilungileyo. Ngenkinga engenziwa njalo nokuthi neziseziso zokusebenza, izinhlobo zakho nokuphela okuningi, siyahlukanisa ukufakwa kokuthatha ukuthi kuyona useto olungileyo olungaphambili, oluziphambili kunye nokuphela okuningi.
Ngokushesha lokuhlola amaviala ezilungileyo, uhlelo oluphambili lokulayisha kunye nobuciko bobunye-bunye bomxoxolo wabahlayisi, sibonisa ukuthi singafunda futhi sifundiswa ngokusingadliwayo nawe ukuze ulandele umthetho wokusetyenziswa, kwaye ukubuka amanani, futhi.
zizamelela ngokulungileyo kwiqhutywa lweqinisekiso lokusebenza, zisenzela ukuba umthetho wokusenzeni kwisebe lemfanekiso. ikhompeni sikwazi ukubuya nokuhlala phakathi komntu okanye ngenxa yokuthi kufuneka kube kusenziwe kumhlaba kunye nokuncedisi, ukuze kuhlaleke imigomo yezilondolozi.
izilondolozi zimekhedwa amakhompiyo CE, FCC kunye neSGS. Siyenza ukukhangela izilondolozi ezilondoloziwe, iinspeksiya ye-produksiya, kwaye nakho amahhadi amabini. Ngoku wonke amandla akwesibhedlela akwenziwe ngendlela yakhe yi-Quality Control. Izinkinga zokugcina kwemfowethu elikhoyo lapho ilondolozi lihlanganiswa.