Chii chinonzi ASME BPE Tubing uye Nei Iri Ndiyo Standard yePharma?

ASME BPE Tubing (American Society of Mechanical Engineers – Bioprocessing Equipment) imhando yakasarudzika yemasisitimu emapaipi nemachubhu akagadzirwa uye akagadzirwa kuti asangane nehutsanana hwakanyanya, kuchena, uye kuenderana kwezvinodiwa zvemaindasitiri emishonga, biotech, uye chikafu nezvinwiwa.

Inotongwa neASME BPE Standard (yazvino 2022), iyo inotsanangura zvinhu, saizi, kupedzisa kwepamusoro, kushivirira, uye zvitupa zvezvikamu zvese muhurongwa hwemvura hwakachena zvakanyanya.

Hunhu Hukuru hweASME BPE Tubing:

1. Zvinhu & Kuumbwa:

· Inonyanya kugadzirwa nesimbi dzisina ngura dzakaita se316L (kabhoni shoma yakakosha kudzivirira "kunzwa" uye ngura pazvishandiso zvewelds).

· Inosanganisirawo mamwe ma alloys akaita se316LVM (Vacuum Melted) kuti inyatsochena, uye simbi dzisina tsvina mbiri dzinoshandiswa pakushandisa mamwe mashandisirwo.

· Kudzora kwakasimba pamakemikari ezvinhu uye kurapwa kwekupisa.

2. Kupedzisa Pamusoro (Kukosha kweRa):

· Ichi chingangove chinhu chakakosha zvikuru. Nzvimbo yemukati (nzvimbo yekubata chigadzirwa) inofanira kunge yakapfava zvikuru uye isina maburi.

· Kupera kunoyerwa ne micro-inches Ra (avhareji yeroughness). Maitiro akajairika eBPE ndeaya:

· ≤ 20 µ-in Ra (0.5 µm): Yekugadzirisa zvinhu zvakajairwa.

· ≤ 15 µ-in Ra (0.38 µm): Yekushandisa kuchena kwakanyanya.

· Yakagadziriswa nemagetsi: Kupera kwakajairika. Maitiro aya emagetsi haangogadzirisi pamusoro chete asiwo anobvisa simbi yakasununguka uye anogadzira jira rechromium oxide rinodzivirira ngura uye kunamatira kwezvikamu.

3. Kusachinja-chinja uye Kushivirira:

· Ine dhayamita yekunze yakamanikana (OD) uye ukobvu hwemadziro zvichienzaniswa nemachubhu akajairwa eindasitiri (seASTM A269).

· Izvi zvinoita kuti pave nekukwana kwakakwana panguva yekushongedza orbital, zvichiita kuti pave nekushongedza kwakatsetseka, kusina mitswe, uye kwakafanana kunokosha kuti pave nekuchena uye kusabereka.

4. Kutevedza & Kupa Chitupa:

· Hurefu hwese hwechubhu hunouya nekutevedza kwakazara kwezvinhu (Nhamba yekupisa, Melt Chemistry, Mishumo yeMill Test Reports).

· Zvitupa zvinosimbisa kuti zvinosangana nezvose zvinodiwa zveBPE standard.

Sei ASME BPE Tubing iri iyo Standard yePharma?

Indasitiri yemishonga, kunyanya yemishonga inobaiwa jekiseni (parenteral) uye biologics, ine zvinodiwa zvisingakurukurwe izvo zvisingagone kusvikwa nemachubhu akajairika.

1. Inodzivirira Kusvibiswa uye Inoita Kuti Chigadzirwa Chive Chakachena:

2. Inogonesa Kuchenesa & Kuchenesa Zvakasimba:

3. Inovimbisa Kuvimbika uye Kuenderana Kwemasisitimu:

4. Inosangana nezvinodiwa nemutemo:

5. Yakakodzera Maitiro Akasiyana-siyana Akakosha:

Muchidimbu, ASME BPE tube ndiyo yakajairika nekuti yakagadzirwa kubva pasi kuti icheneswe, iome, igare, uye itevedzerwe. Haisi kungotsanangurwa kwezvinhu chete; isystem standard yakabatana inotarisa zvakananga zvinodiwa zvemhando yepamusoro uye kuchengetedzeka kwekugadzira mishonga, zvichiita kuti ive chikamu chakakosha chekutevedzera GMP (Good Manufacturing Practice) yemazuva ano.