labarai

Gano Mai Leaching Oxidizing daga Ma'ajin Rubber Syringe Na Asibiti

Ana ƙara amfani da kayan polymeric guda ɗaya a cikin matakai daban-daban na sarrafa biopharmaceutical.Ana iya danganta wannan ga fa'idodin aikace-aikacensu da yawa da sassaucin ra'ayi da daidaitawa, da kuma ƙarancin farashinsu kuma saboda ba a buƙatar ingantaccen tsaftacewa.[1][2]

Gabaɗaya, a ƙarƙashin yanayin amfani na yau da kullun ana kiran mahaɗan sinadarai masu ƙaura da “leachables,” yayin da com-pounds waɗanda ke ƙaura ƙarƙashin ƙayyadaddun yanayin dakin gwaje-gwaje galibi ana kiransu “masu iya cirewa.”Abubuwan da ke faruwa na leachables na iya zama damuwa musamman game da masana'antar likitanci, saboda sunadaran warkewa galibi suna fuskantar gyare-gyaren tsarin da ke iya haifar da kasancewar gurɓatattun abubuwa, idan waɗanda ke ɗaukar ƙungiyoyin aiki.[3][4]Leaching daga kayan gudanarwa ana iya ɗaukar babban haɗari, ko da yake tsawon lokacin tuntuɓar ba zai daɗe sosai idan aka kwatanta da adana dogon lokaci na samfur.[5]
Game da buƙatun tsari, Dokar Amurka ta Dokokin Tarayya Title 21 ta bayyana cewa masana'anta[6] da kuma rufe akwati[7] ba za su canza aminci, inganci ko tsarkin magani ba.Sakamakon haka kuma don tabbatar da ingancin samfurin da aminci na marasa lafiya, abubuwan da suka faru na waɗannan gurɓataccen abu, wanda zai iya samo asali daga yawancin kayan hulɗar DP, yana buƙatar kulawa da sarrafawa a duk matakan sarrafawa, a lokacin masana'antu, ajiya da gudanarwa na ƙarshe.
Tunda ana rarraba kayan gudanarwa gabaɗaya azaman na'urorin kiwon lafiya, masu kaya da masana'anta galibi suna tantancewa da kimanta faruwar baƙin hauren sinadarai gwargwadon abin da aka yi niyya na wani samfur, misali, don jakunkuna, kawai maganin ruwa ya ƙunshi, misali, 0.9% (w) /v) NaCl, an bincika.Duk da haka, an nuna a baya cewa kasancewar sinadarai na halitta tare da kaddarorin solubilizing, irin su furotin na warkewa kanta ko wadanda ba su da ionic surfactants na iya canzawa da haɓaka halayen ƙaura na mahaɗan da ba na polar ba idan aka kwatanta da mafita mai sauƙi na ruwa.[7][8] ]
Don haka makasudin aikin yanzu shine gano abubuwan da za su iya zubar da jini daga sirinji na asibiti da aka saba amfani da su.Don haka, mun yi karatun siminti na in-amfani da za a iya amfani da su ta amfani da 0.1% mai ruwa (w/v) PS20 azaman maganin maye gurbin DP.Abubuwan da aka samo leachables an yi nazarin su ta daidaitattun abubuwan da za a iya cirewa da hanyoyin nazari na leachables.An tarwatsa abubuwan da suka hada da sirinji don gano tushen fitar da sinadari na farko.[9]
A yayin binciken leachables masu amfani akan wani asibiti da aka yi amfani da shi da kuma CE-certified disposable government syringe wani yuwuwar sinadarin carcinogenic41, wato 1,1,2,2-tetrachloroethane an gano shi a cikin ƙima sama da na ICH M7-wanda aka samo asali na kimanta ƙima (AET). ).An fara cikakken bincike don gano abin da ke dauke da robar a matsayin tushen TCE na farko.[10]
Tabbas, zamu iya nuna babu shakka cewa TCE ba za'a iya cirewa daga ma'aunin roba ba.Bugu da ƙari, gwajin ya nuna cewa wani fili da ba a san shi ba tare da kaddarorin oxidizing yana zubewa daga madaidaicin roba, wanda ke da ikon yin oxidize DCM zuwa TCE.[11].
Domin gane leaching fili, da roba stopper da tsantsa aka halin da daban-daban analytical methodologies.Different Organic peroxides, da za a iya amfani da polymerization initiators a lokacin masana'antu na filastik, kayan da aka bincika don iyawar su oxidize DCM zuwa TCE. Don tabbatar da babu shakka na ingantaccen tsarin Luperox⑧ 101 a matsayin fili mai yuwuwar oxidizing, an yi nazarin NMR.An fitar da tsantsar roba na methanolic da ma'aunin ma'aunin Luperox 101 na methanol zuwa bushewa.An sake gina ragowar a cikin methanol-d4 kuma NMR yayi nazari.An tabbatar da cewa mai ƙaddamar da polymerization Luperox⑧101 shine mai iya yin oxidizing na madaidaicin roba na sirinji.[12]
Tare da binciken da aka gabatar a nan, marubutan suna da nufin wayar da kan jama'a game da haɓakar sinadarai daga kayan aikin gudanarwa na asibiti, musamman game da kasancewar "marasa-ganuwa" amma suna da saurin amsa sinadarai.Sa ido kan TCE na iya zama madaidaicin hanya mai dacewa don saka idanu ingancin DP a duk matakan sarrafawa kuma ta haka yana ba da gudummawa ga amincin marasa lafiya.[13]

Magana

[1] Shukla AA, Gottschalk U. fasahohin da za a iya zubar da su guda ɗaya don masana'antar biopharmaceutical.Trends Biotechnol.2013;31 (3): 147-154.

[2] Lopes AG.Amfani guda ɗaya a cikin masana'antar biopharmaceutical: bita na tasirin fasahar-nology na yanzu, ƙalubale da iyakoki.Tsarin Abinci Bioprod.2015; 93: 98-114.

[3] Paskiet D, Jenke D, Ball D, Houston C, Norwood DL, Markovic I. The Product QualityResearch Institute (PQRI) leachables da extractables aiki kungiyar initiatives forparenteral da ophthalmic miyagun ƙwayoyi samfurin (PODP).PDA] Pharm Sci Technol.2013;67 (5):430- 447.

[4] Wang W, Ignatius AA, Thakkar SV.Tasirin ragowar ƙazanta da gurɓataccen abu akan kwanciyar hankali na furotin.J Pharmaceut Sci.2014; 103 (5): 1315-1330.

[5] Paudel K, Hauk A, Maier TV, Menzel R. Ƙididdigar ƙididdiga na leachables suna nutsewa a cikin sarrafa biopharmaceutical na ƙasa.Eur J Pharmaceut Sci.2020; 143: 1 05069.

[6] Hukumar Abinci da Magunguna ta Amurka FDA.21 CFR Sec.211.65, Gina kayan aiki.An sabunta shi daga Afrilu 1, 2019.

[7] Hukumar Abinci da Magunguna ta Amurka FDA.21 CFR Sec.211.94, Akwatunan samfuran ƙwayoyi da rufewa.An sabunta shi daga Afrilu 1, 2020.

[8] Jenke DR, Brennan J, Doty M, Poss M. Amfani da binaryar ethanol / samfurin samfurin ruwa don kwatanta hulɗar tsakanin kayan filastik da magungunan magunguna.[Appl Polvmer Sci.2003:89 (4): 1049- 1057.

[9] Ƙungiyar Ayyukan Ayyukan BioPhorum BPOG.Mafi kyawun jagorar aiki don gwajin abubuwan cirewa na abubuwan amfani guda ɗaya na polymeric da aka yi amfani da su a masana'antar biopharmaceutical.BioPhorum Operations Group Ltd (buga kan layi);2020.

[10] Khan TA, Mahler HC, Kishore RS.Maɓallin hulɗar masu amfani da surfactants a cikin tsarin furotin na warkewa: bita.Farashin jari na FurJ Pharm Riopharm.2015;97 (Pt A): 60- -67.

[11] Ma'aikatar Kiwon Lafiya ta Amurka da Sabis na Dan Adam, Gudanar da Abinci da Magunguna FDA, Cibiyar Nazarin Magunguna da Bincike CDER, Cibiyar Nazarin Halittu da Bincike CBER.Jagora ga masana'antu - kimantawar rigakafi

[12] Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN.Tasirin saman da leachables akan kwanciyar hankali na biopharmaceuticals.J Pharmaceut Sci.2011; 100 (10): 4158- -4170.

[13] Kishore RS, Kiese S, Fischer S, Pappenberger A, Grauschopf U, Mahler HC.Lalacewar polysorbates 20 da 80 da tasirin sa akan kwanciyar hankali na biotherapeutics.Pharm Res.2011;28 (5): 1194-1210.