Kodi ASME BPE Tubing ndi chiyani ndipo chifukwa chiyani ndi muyezo wa Pharma?

ASME BPE Tubing (American Society of Mechanical Engineers – Bioprocessing Equipment) ndi mtundu wapadera wa makina opangira mapaipi ndi mapaipi opangidwa ndi kupangidwa kuti akwaniritse zofunikira zaukhondo, chiyero, komanso kusinthasintha kwa mafakitale opanga mankhwala, biotech, ndi chakudya ndi zakumwa.

Imayendetsedwa ndi ASME BPE Standard (kope laposachedwa ndi 2022), lomwe limatanthauzira zipangizo, miyeso, zomaliza pamwamba, kulekerera, ndi ziphaso za zigawo zonse mu machitidwe amadzimadzi oyera kwambiri.

Makhalidwe Ofunika a Machubu a ASME BPE:

1. Zipangizo & Kapangidwe:

· Chopangidwa makamaka ndi zitsulo zosapanga dzimbiri za austenitic monga 316L (kuchepa kwa mpweya woipa ndikofunikira kwambiri kuti tipewe "kukhudzidwa" ndi dzimbiri pa ma welds).

· Zimaphatikizaponso zinthu zina monga 316LVM (Vacuum Melted) kuti zikhale zoyera kwambiri, ndi zitsulo zosapanga dzimbiri ziwiri zomwe zimagwiritsidwa ntchito pazinthu zina.

· Kuwongolera mwamphamvu pa mankhwala a zinthu ndi kutentha.

2. Kumaliza Pamwamba (Mtengo wa Ra):

· Ichi mwina ndi chinthu chofunikira kwambiri. Mbali yamkati (yomwe imakhudzana ndi chinthu) iyenera kukhala yosalala kwambiri komanso yopanda mabowo.

· Kutha kumayesedwa mu micro-inchi Ra (avereji ya roughness). Mafotokozedwe odziwika bwino a BPE ndi awa:

· ≤ 20 µ-in Ra (0.5 µm): Ya bioprocessing yokhazikika.

· ≤ 15 µ-in Ra (0.38 µm): Kuti mugwiritse ntchito bwino kwambiri.

· Yopukutidwa ndi electropolished: Kumaliza kokhazikika. Njira yamagetsi iyi sikuti imangosalala pamwamba komanso imachotsa chitsulo chopanda kanthu ndikupanga gawo la chromium oxide lomwe limakana dzimbiri ndi tinthu tomwe timamatira.

3. Kusasinthasintha ndi Kulekerera:

· Ili ndi ma dayamita akunja opapatiza kwambiri (OD) ndi makulidwe a khoma poyerekeza ndi machubu wamba a mafakitale (monga ASTM A269).

Izi zimatsimikizira kuti zinthu zikugwirizana bwino panthawi yolumikiza zinthu, zomwe zimapangitsa kuti zinthu zizikhala zosalala, zopanda ming'alu, komanso zogwirizana zomwe ndizofunikira kuti zinthu zikhale zoyera komanso zosabala.

4. Kutsata ndi Chitsimikizo:

· Kutalika kulikonse kwa chubu kumabwera ndi kutsata kwathunthu kwa zinthu (Nambala ya Kutentha, Kusungunuka kwa Chemistry, Malipoti Oyesera a Mill).

· Zikalata zotsimikizira kuti zikukwaniritsa zofunikira zonse za muyezo wa BPE.

Chifukwa chiyani ASME BPE Tubing ndiye muyezo wa Pharma?

Makampani opanga mankhwala, makamaka mankhwala obayidwa jakisoni (parenteral) ndi biologics, ali ndi zofunikira zomwe sizingakambiranedwe zomwe mapaipi wamba sangakwaniritse.

1. Zimaletsa Kuipitsidwa ndi Kuonetsetsa Kuti Zinthu Zili Zoyera:

2. Kuthandiza Kuyeretsa ndi Kuyeretsa Kovomerezeka:

3. Kuonetsetsa Kuti Dongosolo Lili Logwirizana Ndi Kukhulupirika:

4. Kukwaniritsa Zoyembekezeka Zoyang'anira:

5. Yoyenera Njira Zosiyanasiyana Zofunikira:

Mwachidule, ASME BPE chubu ndi muyezo chifukwa chapangidwa kuyambira pansi kuti chikhale choyeretsedwa, choyeretsedwa, chokhazikika, komanso chosavuta kutsatira. Sizongoganizira zinthu zokha; ndi muyezo wophatikizidwa womwe umayang'ana mwachindunji zofunikira zazikulu za khalidwe ndi chitetezo cha kupanga mankhwala, zomwe zimapangitsa kuti chikhale gawo lofunikira kwambiri pakutsata malamulo amakono a GMP (Good Manufacturing Practice).