ASME BPE Tubing yog dab tsi thiab vim li cas nws thiaj yog tus qauv rau Pharma?

ASME BPE Tubing (American Society of Mechanical Engineers - Bioprocessing Equipment) yog ib hom tubing thiab piping system tshwj xeeb uas tsim thiab tsim los ua kom tau raws li qhov yuav tsum tau ua kom huv si, huv si, thiab sib xws ntawm cov lag luam tshuaj, biotech, thiab zaub mov & dej haus.

Nws yog tswj hwm los ntawm ASME BPE Standard (tsab tshiab tshaj plaws yog 2022), uas txhais cov ntaub ntawv, qhov ntev, qhov chaw tiav, kev kam rau siab, thiab daim ntawv pov thawj rau txhua yam khoom hauv cov kua dej ntshiab siab.

Cov yam ntxwv tseem ceeb ntawm ASME BPE Tubing:

1. Khoom siv & Cov khoom xyaw:

· Ua los ntawm cov hlau tsis xeb austenitic xws li 316L (cov pa roj carbon tsawg yog qhov tseem ceeb rau kev tiv thaiv "kev rhiab heev" thiab xeb ntawm cov vuam).

· Kuj suav nrog lwm cov hlau xws li 316LVM (Nqus Tsev Yaj) rau qhov huv dua, thiab cov hlau tsis xeb duplex rau qee yam kev siv.

· Kev tswj hwm nruj ntawm cov khoom siv tshuaj lom neeg thiab kev kho cua sov.

2. Qhov Chaw Tiav (Ra Tus Nqi):

· Qhov no yog qhov tseem ceeb tshaj plaws. Sab hauv (qhov chaw sib cuag ntawm cov khoom) yuav tsum du thiab tsis muaj qhov.

· Qhov tiav yog ntsuas hauv micro-inches Ra (roughness average). Cov lus qhia BPE feem ntau yog:

· ≤ 20 µ-in Ra (0.5 µm): Rau kev ua bioprocessing txheem.

· ≤ 15 µ-in Ra (0.38 µm): Rau cov ntawv thov purity siab dua.

· Electropolished: Qhov tiav txheem. Cov txheej txheem electrochemical no tsis yog tsuas yog ua kom du qhov chaw xwb tab sis kuj tshem tawm cov hlau dawb thiab tsim cov txheej chromium oxide passive uas tiv taus kev xeb thiab cov khoom me me lo rau.

3. Kev Sib Xws thiab Kev kam rau siab ntawm qhov ntev:

Muaj qhov sib txawv ntawm txoj kab uas hla sab nraud (OD) thiab phab ntsa tuab dua piv rau cov kav dej kev lag luam txheem (xws li ASTM A269).

· Qhov no ua kom ntseeg tau tias muaj kev sib haum xeeb zoo thaum lub sijhawm vuam orbital, tsim kom muaj kev vuam du, tsis muaj qhov tawg, thiab sib xws uas tseem ceeb rau kev ntxuav thiab tsis muaj kab mob.

4. Kev taug qab thiab Daim Ntawv Pov Thawj:

Txhua qhov ntev ntawm cov kav dej muaj qhov taug qab tag nrho cov khoom siv (Tus lej kub, Melt Chemistry, Mill Test Reports).

· Cov ntawv pov thawj lees paub tias nws ua tau raws li txhua yam uas yuav tsum tau ua ntawm tus qauv BPE.

Vim li cas ASME BPE Tubing thiaj yog Tus Qauv rau Pharma?

Kev lag luam tshuaj, tshwj xeeb tshaj yog rau cov tshuaj txhaj (parenteral) thiab cov tshuaj biologics, muaj cov kev cai uas tsis tuaj yeem sib tham tau uas cov yeeb nkab generic tsis tuaj yeem ua tau.

1. Tiv Thaiv Kev Ua Phem & Xyuas Kom Cov Khoom Huv Si:

2. Ua kom muaj kev ntxuav thiab tua kab mob uas tau lees paub:

3. Xyuas kom meej tias lub kaw lus muaj kev ncaj ncees thiab kev sib xws:

4. Ua tau raws li kev cia siab ntawm txoj cai:

5. Haum rau ntau yam txheej txheem tseem ceeb:

Hauv kev xaus lus, ASME BPE tubing yog tus qauv vim nws tau tsim los ntawm hauv av kom huv si, sterilizable, sib xws, thiab taug qab. Nws tsis yog tsuas yog cov lus qhia txog cov khoom siv xwb; nws yog ib qho qauv kev sib koom ua ke uas hais txog qhov tseem ceeb ntawm kev tsim tshuaj, ua rau nws yog ib feem tseem ceeb ntawm kev ua raws li GMP (Good Manufacturing Practice) niaj hnub no.