M'makampani opanga mankhwala, njira iliyonse yopanga imakhudzana ndi chitetezo cha odwala. Kuchokera ku zosankha zopanga njira zopangira, kuchokera ku zida kuyeretsa kuwongolera zachilengedwe, kuwonongeka kulikonse komwe kungayambitse zoopsa zamankhwala. Mwa maulalo ofunikira awa,Poneraserical yoyera yamafutayakhala imodzi mwazida zopambana zowonetsetsa chitetezo cha mankhwala chifukwa cha udindo wawo wosankha. Sikuti zimangotsimikizira zodalirika za asepric, komanso ndi mwala wofunika kwambiri wamakampani amakono opanga zamakono kuti azisunthira kumiyeso yapamwamba komanso yapamwamba kwambiri.

STALE YOSAVUTA: Niceline wa zopangidwa ndi mankhwala

Zofunikira zaukhondo pakupanga mankhwala opanga mankhwala zimakhala ngati zikopa. Kaya ndi jakisoni, biologics, katemera, kapena mankhwala, zida, ziphuphu, ziphuphu, ngakhale malo omwe amakhudzidwa ndi ntchito sizimatha kukhala zomatira. Stute yoyera (yodziwikanso ngati "Pulogalamu ya Pulogalamu ya Plarmaceumical") yakhala yosasunthika pakati pa malonda ogulitsa mankhwala chifukwa cha zotsalira zake kwambiri komanso kusowa kwa zotsalira zamankhwala.

Chonyamula chapamwamba cha chosawilitsidwa

Stuam yoyera imatha kulowa makhoma a cell acrobial ndikupha kwathunthu mabakiteriya, ma virus, ndipo amasungunuka kutentha kwambiri (nthawi zambiri pamwamba pa 121 ℃) komanso kukakamizidwa kwambiri. Poyerekeza ndi mankhwala opha mankhwala, otenthetsera osakhazikika alibe chiopsezo, makamaka zida ndi zotengera zomwe zimakumana ndi mankhwala osokoneza bongo. Mwachitsanzo, kuphatikiza kwa zida zofunikira monga jakisoni kudzaza mizere, makina owuma, ndipo bioreacrors amadalira malo oyenera a Steam Oyera.

Kukhazikika kwa miyezo yapamwamba

Malinga ndi GMP Zofunikira, Stermacial Prosem Lice iyenera kukumana ndi zisonyezo zitatuzi:

Palibe gwero lotentha: gwero lotentha limayamba chifukwa chodetsa matenda olimbirana mwa odwala ndipo ziyenera kuchotsedwa kwathunthu.

Madzi ophatikizidwa amakumana ndi muyeso: Madzi am'madzi atatha kutsimikizika kwathunthu kuyenera kukumana ndi madzi a jakisoni (WFI) muyezo, wokhala ndi moyo wa ≤ 1.3 μ s / cm.

Mtengo woyenerera: kuuma kwa nthunzi kuyenera kukhala ≥ 9% kupewa madzi omwe akukhudzidwa ndi zotsatira zosankhiratu.

Kugwiritsa ntchito bwino ntchito

Kuchokera pa intaneti (sip) mwa zida zopanga kuti mpweya wabwino ukhale chipinda choyera mu chipinda choyera, kuchokera ku zovala zosalala kuti usayendetse matenda opangira mankhwala opangira mankhwala. Makamaka m'lingaliro la Aseptic Pokonzekera, jenereta yoyera ndi "gwero lamphamvu" lomwe limayenda pafupifupi maola 24 patsiku osasokoneza

Ufulu Waukadaulo Wopanga Mafuta Oyera

Ndi ntchito yowonjezereka kuti ikhale yabwino, yochita bwino, komanso kuteteza chilengedwe m'makampani opanga mankhwala, ukadaulo wamafuta angwiro nthawi zonse umadutsa. Zipangizo zamakono zakwaniritsa chitetezo chapamwamba komanso mphamvu zoyendetsera mphamvu kudzera mwanzeru komanso zopangidwa modekha.

Kugonjera M'maluso Pachilengedwe

Kusintha kwaukadaulo wambiri: Kudzera muyezo wochiritsidwa, madzi osaphika (nthawi zambiri madzi oyeretsedwa) amasandutsidwa kukhala nthunzi yoyera, kuchepetsa mphamvu zoposa 30% poyerekeza ndi zida zachikhalidwe.

Kuwongolera Kwanzeru: Kudziwika ndi makina owunikira okhathamiritsa, kutentha kwa nthawi yayitali, kutentha, komanso kukakamizidwa kwanthawiyo, kusinthidwa kwanthawi zonse, kupewa zolakwika za anthu.

Mapangidwe a kaboni otsika: Kutengera zida zonyansa kutentha kuti muchepetse zinyalala zamphamvu, mogwirizana ndi kusintha kwa malonda obiriwira.

'Inshuwaransi Inallo' ya Chitsimikizo Chachikulu

Mitundu yamakono yamakono imakhala ndi njira zotsimikizika ziwiri:

Kuwunika kwa pa intaneti: Kuyang'anira nthawi yeniyeni yoyeza matenthedwe kudzera pazida monga machitidwe a mamita ndi openda toc.
Desictive: Kalupu kakang'ono kambiri, kafukufuku wambiri ndi mapangidwe ena awonetsetse kuti akugwiritsa ntchito zida ngati zolephera mwadzidzidzi.

Kusinthasintha poyankha zofuna zovuta

Kupanga kwamatumbo koyera kumatha kusintha minda yotuluka monga biopharmaceuticals ndi cell mankhwala. Mwachitsanzo, zida zomwe zimagwiritsidwa ntchito popanga katemera katemera zimafunikira kukwaniritsa zofunika kwambiri, ndipo makampani ena akhazikitsa "ukadaulo wa ultra weniweni" kuti athe kuwongolera gawo la endotoxin mu 0,001 eu / ml.
Ndi chitukuko chachangu cha biopharmaceuticals, zofunikira zapamwamba zakhala zikuyikidwa patsogolo pa mtundu wa nthunzi yoyera. Kupanga kwa mankhwala atsopano monga mankhwala osokoneza bongo komanso ma antibodies amafunikira malo otetezeka. Izi zikuwonetsa zovuta zatsopano zamitundu yamitundu yoyera.

Lingaliro lopanga zobiriwira zikusintha kapangidwe kake kamene kamapanga majeremusi oyera. Kugwiritsa ntchito zida zopulumutsa mphamvu, zinthu zachilengedwe zachilengedwe, komanso kukula kwa magwiridwe antchito anzeru ndikuyendetsa mabizinesi kuti ikhale yolingana.

Kugwiritsa ntchito mwaluso mwaluso kumayambitsa njira yogwiritsira ntchito makina opanga matenthedwe. Kukhazikitsa kwa kuwunikira zakutali, kusintha kwanzeru, kusintha kwanzeru komanso ntchito zina sizimangosintha bwino ntchito zamagetsi, komanso zimatipatsa chitsimikizo chabwino chothandizira kupanga mankhwala.

Masiku ano, monga chitetezo chamankhwala chikufunika kwambiri, kufunikira kwaMitundu ya mankhwala osokoneza bongoikukulirakulira. Sichinthu chofunikira chokha chopanga mankhwala osokoneza bongo, komanso cholepheretsa kuwonetsetsa kuti anthu amagwiritsa ntchito. Ndi kupititsa patsogolo kupititsa patsogolo ukadaulo, mayiko sakhala ndi gawo lalikulu m'makampani opanga mankhwala ndikupanga zopereka zazikulu za thanzi la anthu.