Kuyini i-ASME BPE Tubing futhi Kungani Kuyindinganiso Ye-Pharma?

I-ASME BPE Tubing (i-American Society of Mechanical Engineers – Imishini Yokucubungula Izinto Eziphilayo) uhlobo olukhethekile lwesistimu yamapayipi namapayipi eklanyelwe futhi yakhiqizwa ukuze ihlangabezane nezidingo zokuhlanzeka okukhulu, ubumsulwa, kanye nokuvumelana kwezimboni zemithi, ze-biotech, kanye nezokudla neziphuzo.

Ilawulwa yi-ASME BPE Standard (uhlelo lwakamuva lungo-2022), oluchaza izinto zokwakha, ubukhulu, ukuqedwa kwendawo, ukubekezelelana, kanye nezitifiketi zazo zonke izingxenye ezinhlelweni zoketshezi oluhlanzekile kakhulu.

Izici Eziyinhloko Zokusebenzisa Amapayipi E-ASME BPE:

1. Izinto Nokwakheka:

· Yenziwe ngokuyinhloko ngezinsimbi ezingagqwali ze-austenitic ezifana ne-316L (okuqukethwe okuphansi kwekhabhoni kubalulekile ukuvimbela "ukuzwela" kanye nokugqwala kuma-welds).

· Kuhlanganisa nezinye izinhlobo ze-alloy ezifana ne-316LVM (Vacuum Melted) ukuze kube nobumsulwa obukhulu nakakhulu, kanye nezinsimbi ezingagqwali ezimbili zezinhlelo zokusebenza ezithile.

· Ukulawulwa okuqinile kwe-chemistry yezinto ezibonakalayo kanye nokwelashwa kokushisa.

2. Ukuqeda Okungaphezulu (Inani le-Ra):

· Lesi yisici esibaluleke kakhulu. Ingaphakathi (indawo yokuxhumana komkhiqizo) kumele libe bushelelezi kakhulu futhi lingabi nezimbobo.

· Ukuphela kukalwa ngamasentimitha amancane uRa (isilinganiso sobukhali). Imininingwane evamile ye-BPE yile:

· ≤ 20 µ-in Ra (0.5 µm): Yokucubungula okujwayelekile kwe-bio.

· ≤ 15 µ-in Ra (0.38 µm): Ukuze kusetshenziswe ubumsulwa obuphezulu.

· I-Electropolished: Ukuphela okujwayelekile. Le nqubo ye-electrochemical ayigcini nje ngokushelela ubuso kodwa futhi isusa insimbi yamahhala futhi idale ungqimba lwe-chromium oxide olungasebenzi olumelana nokugqwala kanye nokunamathela kwezinhlayiya.

3. Ukuvumelana Nokubekezelelana Okunezilinganiso:

· Ine-diameter yangaphandle eqinile (OD) kanye nokubekezelela ukujiya kodonga uma kuqhathaniswa namapayipi ajwayelekile ezimboni (njenge-ASTM A269).

Lokhu kuqinisekisa ukulingana okuphelele ngesikhathi sokushisela kwe-orbital, okudala ukushisela okubushelelezi, okungenamifantu, nokungaguquguquki okubalulekile ekuhlanzekeni nasekungazalisi.

4. Ukulandelela kanye Nesitifiketi:

· Ubude ngabunye bepayipi buhambisana nokulandeleka okugcwele kwezinto (Inombolo Yokushisa, I-Melt Chemistry, Imibiko Yokuhlolwa Kwesigayo).

· Izitifiketi ziqinisekisa ukuthi ziyahlangabezana nazo zonke izidingo zezinga le-BPE.

Kungani i-ASME BPE Tubing iyindinganiso ye-Pharma?

Imboni yezemithi, ikakhulukazi yemithi ejovwayo (engadingi ukujova) kanye ne-biologics, inezidingo ezingaxoxiswana ngazo ezingenakukwazi ukuhlangabezana namapayipi ajwayelekile.

1. Kuvimbela Ukungcola Futhi Kuqinisekisa Ukuhlanzeka Komkhiqizo:

2. Ivumela Ukuhlanza Nokuhlanza Okuqinisekisiwe:

3. Kuqinisekisa Ubuqotho Nokungaguquguquki Kwesistimu:

4. Ihlangabezana Nokulindelekile Kwemithetho:

5. Kufanelekela Izinqubo Ezibanzi Ezibucayi:

Ngamafuphi, ipayipi le-ASME BPE liyindinganiso ngoba lakhiwe kusukela phansi ukuze lihlanzeke, lihlanzwe, lihambisane, futhi lilandeleleke. Akuyona nje imininingwane yezinto ezibonakalayo; kuyindinganiso yesistimu ehlanganisiwe ebhekana ngqo nezidingo zekhwalithi kanye nokuphepha okuyinhloko kokukhiqizwa kwemithi, okwenza kube yingxenye ebalulekile yokuhambisana ne-GMP (Good Manufacturing Practice) yesimanje.