Buku Lotsogolera la Mainjiniya la ASME BPE: Kodi SF1 Kupyolera mu SF6 Imatanthauza Chiyani Kwenikweni?

Tiyeni tifotokoze tanthauzo la SF1 mpaka SF6 kuchokera pamalingaliro aukadaulo.

Choyamba, muyezo wa ASME BPE (BioProcessing Equipment) umagwiritsa ntchito mayina awa kugawa zigawo kutengera momwe zimagwiritsidwira ntchito munjira yamadzimadzi komanso mulingo wotsimikizira khalidwe ndi zikalata zoperekedwa ndi wopanga.

Si chinthu chofunikira pa zinthu zakuthupi. Cholumikizira cha chitsulo chosapanga dzimbiri cha 316L chingapangidwe kuti chikhaleMlingo wa SF1, SF3, kapena SF5.Kusiyana kwake kuli m'mene zidapangidwira, kufufuzidwa, ndi kulembedwa.

SF1 - Giredi Yamalonda / Yamafakitale

· Zoona Zake: Izi ndi zokhazikika, zogwiritsidwa ntchito popanga mapaipi, mapaipi, ndi zolumikizira. Zilibe ziphaso zapadera ndipo sizinapangidwe kuti zigwiritsidwe ntchito pokhudzana mwachindunji ndi mankhwala m'malo olamulidwa ndi biopharma.

· Nthawi Yogwiritsira Ntchito: Pa mizere yamagetsi yomwe siikhudzana ndi chinthu (monga nthunzi ya zomera, madzi ozizira, mafelemu othandizira mpweya wa chipangizo). Kugwiritsa ntchito SF1 mu mzere wa chinthu kapena CIP/SIP (Clean-in-Place / Steam-in-Place) ndi chiopsezo chachikulu chotsata malamulo.

SF2 - Yomalizidwa Mochepa

· Zoona: Ili ndi gulu lomwe siligwiritsidwa ntchito kawirikawiri. Zigawo zake zimapangidwa kuchokera ku zinthu zopangira zomwe zimakwaniritsa zofunikira za BPE chemistry, koma chinthu chomaliza chokha sichinatsimikizidwe mokwanira. Taganizirani izi ngati sitepe yoposa SF1 koma sichinayeneretsedwe mokwanira.

· Nthawi Yogwiritsira Ntchito: Ndi "malo otuwa." Nthawi zambiri samaloledwa kugwiritsa ntchito makina ofunikira. Angapezeke m'makina ena othandizira omwe si ofunikira kwenikweni komwe kuyera kwa zinthu si nkhani yayikulu koma satifiketi yonse ya BPE siyoyenera.

SF3 - Chogulitsa Chokhazikika cha BPE

· Zoona Zake: Iyi ndi ntchito yaikulu ya makampani opanga zinthu zamoyo. Ngati kujambula kumafuna "kuyenerera kwa BPE," nthawi zambiri kumakhala kuganiza kuti SF3 ndi yocheperako. Iyi ndi giredi yovomerezeka pa kukhudzana kulikonse kwa chinthu kapena CIP/SIP system.

· Nthawi Yogwiritsira Ntchito: Kulikonse munjira ya chinthucho. Zopangira, zoyeretsera zinthu, zotchingira chromatography, matanki osungira, ndi mapaipi onse okhudzana ndi chinthucho, buffer, ndi madzi a CIP/SIP.

SF4 - Chogulitsa cha BPE Chopanikizika Kwambiri

· Zoona Zake: Iyi ndi SF3 yomwe imayesedwa kuti ikhale ndi kalasi yokwera kwambiri. Zofunikira zonse za SF3 ndi zolemba zimagwira ntchito.

Nthawi Yogwiritsira Ntchito: Mu makina opanikizika kwambiri, monga omwe amapezeka mu ma skid ena osefera, chromatography yopanikizika kwambiri, kapena ntchito iliyonse yomwe kuthamanga kwa kapangidwe kumapitirira muyezo wokhazikika wa zigawo za SF3.

SF5 - Kuyang'anira Kulandira Kukonza Zinthu Zamoyo

· Zoona Zake: Ichi ndi gawo la SF3 lomwe wogwiritsa ntchito (inu, kampani ya biopharma) mwaliyang'ana ndikuvomereza payekhapayekha. Wopanga amapereka gawolo ndi ziphaso zake, koma inuyo mumachita kafukufuku wanu wowonjezera komanso wokhwima.

· Nthawi Yogwiritsira Ntchito: Pa ntchito zofunika kwambiri pomwe kulephera si njira yabwino (monga mizere yomaliza yopangira zinthu, mizere yodzaza). Izi zimawonjezera mtengo ndi nthawi yambiri koma zimapereka chidaliro chachikulu pa khalidwe la gawolo.

SF6 - Wogulitsa Wopezeka ndi Wovomerezeka

· Zoona Zake: Ichi ndi satifiketi ya "black box". Mukukhulupirira wopanga zinthu (wogulitsa) kuti achite kafukufuku wofanana ndi womwe mungachitire SF5. Wogulitsayo amapereka satifiketi yosonyeza kuti chinthucho chikukwaniritsa zofunikira zonse za SF5.

· Nthawi Yogwiritsira Ntchito: Ngati mukufuna chitsimikizo cha khalidwe la SF5 koma mulibe luso loyang'anira mkati mwa kampani kapena mukufuna kusintha unyolo wogulira. Zimafunika kudalirika kwambiri komanso mgwirizano wolimba wa khalidwe ndi wogulitsa.

Mukamvetsetsa magulu awa, mutha kupanga zisankho zodziwikiratu, zotsika mtengo, komanso zotsatizana ndi kapangidwe ka makina anu opangira zinthu zamoyo.