Yintoni i-ASME BPE Tubing kwaye kutheni iyindlela eqhelekileyo ye-Pharma?

I-ASME BPE Tubing (i-American Society of Mechanical Engineers – iBioprocessing Equipment) luhlobo olukhethekileyo lwenkqubo yepayipi kunye nemibhobho eyilwe kwaye yenziwe ukuze ihlangabezane neemfuno zococeko olugqithisileyo, ubunyulu, kunye nokuhambelana kwemizi-mveliso yamayeza, i-biotech, kunye nokutya neziselo.

Ilawulwa yi-ASME BPE Standard (uhlelo lwamva nje yi-2022), echaza izixhobo, ubukhulu, ukugqitywa komphezulu, ukunyamezela, kunye neziqinisekiso zazo zonke izinto kwiinkqubo zolwelo olucocekileyo kakhulu.

Iimpawu eziphambili ze-ASME BPE Tubing:

1. Izinto kunye noKwakhiwa:

· Yenziwe ngokuyintloko ngeentsimbi ezingenasici ze-austenitic ezifana ne-316L (umxholo ophantsi wekhabhoni ubalulekile ukuthintela "ukuzwela" kunye nokugqwala kwii-welds).

· Ikwabandakanya nezinye ii-alloys ezifana ne-316LVM (iVacuum Melted) ukuze zibe nobunyulu obuphezulu, kunye neentsimbi eziqinileyo ezimbini zezixhobo ezithile.

· Ulawulo olungqongqo kwikhemistri yezinto kunye nonyango lobushushu.

2. Ukugqitywa komphezulu (Ixabiso leRa):

· Olu lolona phawu lubalulekileyo. Umphezulu wangaphakathi (umphezulu wokudibana kwemveliso) kufuneka ube mpuluswa kakhulu kwaye ungabi namingxuma.

· Ukugqitywa kulinganiswa nge-micro-intshi Ra (umyinge woburhabaxa). Iinkcukacha eziqhelekileyo ze-BPE zezi:

· ≤ 20 µ-in Ra (0.5 µm): Ye-bioprocessing eqhelekileyo.

· ≤ 15 µ-in Ra (0.38 µm): Kwizicelo zokucoca okuphezulu.

· I-Electropolished: Isiphelo esiqhelekileyo. Le nkqubo ye-electrochemical ayipheleli nje ekugudiseni umphezulu kodwa ikwasusa i-iron ekhululekileyo kwaye idala umaleko we-chromium oxide ongasebenziyo omelana nokugqwala kunye nokunamathela kwamasuntswana.

3. Ukungaguquguquki kunye nokunyamezelana okunemilinganiselo:

· Ine-diameter yangaphandle eqine kakhulu (OD) kunye nokumelana nobukhulu bodonga xa kuthelekiswa neetyhubhu eziqhelekileyo zemizi-mveliso (njenge-ASTM A269).

· Oku kuqinisekisa ukulingana ngokugqibeleleyo ngexesha lokuwelda kwe-orbital, kudala ukuwelda okugudileyo, okungenamiqolo, kunye nokungaguquguqukiyo okubalulekileyo ekucocekeni nasekungazalisi.

4. Ukulandelelana kunye neSatifikethi:

· Ubude ngabunye betyhubhu buza nokulandeleka kwezinto ezifunekayo (Inombolo yoBushushu, iKhemistri yokuNcibilika, iiNgxelo zoVavanyo lweMill).

· Iziqinisekiso ziqinisekisa ukuba ziyahlangabezana nazo zonke iimfuno zomgangatho we-BPE.

Kutheni i-ASME BPE Tubing iyimigangatho yePharma?

Ishishini lamayeza, ingakumbi amayeza afakwa kwi-injection (parenteral) kunye ne-biologics, lineemfuno ezingaxoxiswaniyo ezingenakukwazi ukuhlangabezana ne-generic tube.

1. Ithintela ukungcoliseka kwaye iqinisekisa ukucoceka kwemveliso:

2. Ivumela ukuCoca kunye nokubulala iintsholongwane okuQinisekisiweyo:

3. Ukuqinisekisa uBulungisa kunye nokuNgaguquguquki kweNkqubo:

4. Ihlangabezana nolindelo lweMithetho:

5. Ifanelekile kwiinkqubo ezininzi ezibalulekileyo:

Ngamafutshane, i-ASME BPE tubes ngumgangatho kuba yenzelwe ukusuka emhlabeni ukuya phezulu ukuze icoceke, ingabi namagciwane, ihambelane, kwaye ilandeleke. Ayisiyo nje inkcazo yezinto ezibonakalayo; ngumgangatho wenkqubo edibeneyo ejongana ngqo neemfuno eziphambili zomgangatho kunye nokhuseleko lwemveliso yamayeza, okwenza ukuba ibe yinxalenye ebalulekileyo yokuthobela i-GMP yanamhlanje (i-Good Manufacturing Practice).