GMP-Yujuje indege ya Farma ninganda zikora ibiribwa

Niki gituma gusya Jet ihitamo neza kumiti ya farumasi nibiryo? Wigeze wibaza uburyo imiti ninyongeramusaruro ikorwa mubifu ya ultra-nziza itabuze ubuziranenge? Mu nganda nka farumasi n'ibiribwa, ubuziranenge n'isuku ntabwo ari byiza kugira - birasabwa n'amategeko. Aho niho hasya urusyo.

Gusya indege ninzira yubuhanga buhanitse ikoresha imigezi yihuta yihuta yo gusya ibikoresho mubifu nziza. Bitandukanye nuburyo busanzwe bwo gusya bukoresha ibyuma cyangwa ibizunguruka, gusya indege nta bice byimuka bikora ku bicuruzwa. Ibi bituma biba byiza mubisabwa bisaba isuku ihamye hamwe nuduce duto-nka farumasi n’ibicuruzwa.

Kuki kubahiriza GMP ari ngombwa cyane?

GMP, cyangwa uburyo bwiza bwo gukora, ni igipimo cyisi yose kugirango ubuziranenge bwumutekano n'umutekano. Mu nganda zombi zibiribwa na farumasi, gukurikira GMP ntabwo ari ngombwa. Ni ngombwa.

Sisitemu yo gusya indege ya GMP igomba kuba:

1.Isuku: Yagenewe gukumira umwanda kuri buri cyiciro

2.Byoroshye guhanagura: Korohereza imbere imbere no gusenya ibikoresho

3.Ibisobanuro: Bashoboye kugumana ingano ihamye ya buri cyiciro

4.Ibyangombwa: Bifite ibikoresho byuzuye byo kugenzura no kugenzura ibyiciro

Ibikoresho byo gusya indege bitujuje ibi bipimo birashobora guhura nibibazo, gutsindira ibicuruzwa, cyangwa ibihano bigenga.

Uburyo Jet Milling ikora-n'impamvu ari nziza

Gusya indege ikora byihutisha umwuka wangiritse cyangwa gaze ya inert ikoresheje nozzles mucyumba cyo gusya. Ibice by'imbere bigongana n'umuvuduko mwinshi, bigabanyamo ubunini buhebuje-akenshi nka microne 1-10.

Kuki iyi nzira ari nziza kubidukikije bya GMP?

1.Ntabwo kubyara ubushyuhe: Byuzuye kubintu byangiza ubushyuhe

2.Nta ngaruka zo kwanduza: Kuberako nta bitangazamakuru bisya bikoreshwa

3.Gucunga ibice byingirakamaro: Nibyingenzi mukunywa ibiyobyabwenge cyangwa ibiryo

4.Ibisubizo bifatika: Kuva muri laboratoire-nini kugeza ku nganda zinganda

Gusya Jet mubikorwa: Farma nibisabwa

Muri farumasi, gusya indege bikoreshwa cyane kuri API (Ibikoresho bifatika bya farumasi). Kurugero, ubushakashatsi bwasohotse muri Pharmaceutical Development and Technology bwerekanye ko ibuprofen yasunitswe nindege yageze ku gipimo cya 30% yihuta ugereranije n’urusyo rusanzwe rusya, rutezimbere ibiyobyabwenge.

Mu rwego rw’ibiribwa, gusya indege bikoreshwa mu gutunganya ifu y uburyohe, enzymes, hamwe n’inyongeramusaruro y’ibiribwa nka calcium karubone cyangwa proteine yitaruye, aho uburinganire n’isuku ari ngombwa. Akarorero kerekana: raporo yo mu 2022 yakozwe n’ikigo cy’ibihugu by’Uburayi gishinzwe umutekano w’ibiribwa (EFSA) yashimangiye uruhare rwa micronisation mu kuzamura bioavailable y’ibiribwa bikora.

Ibyingenzi byingenzi bya GMP-yujuje ibikoresho byo gusya

Sisitemu yo gusya indege yakozwe mugukoresha imiti nibiryo byo murwego birimo:

1.Ibishushanyo mbonera byuzuye ibyuma (304 cyangwa 316L)

2.Ubuso bukabije Ra ≤ 0.4μm kugirango bisukure byoroshye

3.CIP (Isuku-mu-mwanya) na SIP (Sterilize-mu-mwanya) guhuza

4.ATEX yubahiriza kandi iturika-iturika ryumutekano

5.Gusobanura neza ibyiciro byemeza gukwirakwiza ibice bito

Izi sisitemu zifasha ababikora kuzuza ibisabwa FDA, EU GMP, na CFDA mugihe bagabanya igihe cyo hasi no kunoza ubudahwema.

Kuki uhitamo Qiangdi kubyo ukeneye byo gusya?

Ku bikoresho byo gusya bya Kunshan Qiangdi, tuzobereye mugutanga ibisubizo bya GMP byujuje ibisubizo byujuje ibisabwa byihariye mu nganda zimiti n’ibiribwa. Dore impamvu abayobozi b'inganda batwizera:

1.Ibicuruzwa byinshi:

Kuva ku ruganda rutemba rwamazi kugeza kuri ultra-nziza itondekanya, dutanga amahitamo manini ya laboratoire, umuderevu, nibikorwa byuzuye.

2. Ibishushanyo by'isuku & byemejwe:

Sisitemu yacu yo mu rwego rwa farumasi yujuje ubuziranenge bwa GMP / FDA, kandi igaragaramo 304 / 316L kubaka ibyuma bitagira umwanda, gusiga indorerwamo, no gusenya byoroshye.

3. Guturika-Ibihamya na Sisitemu Yangiza Ibidukikije:

Dutanga ATEX yemewe, idafite umukungugu, hamwe na sisitemu yo kugenzura ubwenge ikwiriye ibyago byinshi kandi byogusukura.

4. Ubuhanga bwihariye:

Ukeneye gushiraho bidasanzwe? Itsinda ryacu R&D rirashobora guhinduranya ikirere, umuvuduko wa classifier, hamwe no gusya ingano yicyumba kugirango uhuze intego zawe.

5. Kugera kwisi yose, Inkunga yibanze:

Twakoreye abakiriya mu bihugu birenga 40 mu nganda nka farumasi, imiti y’ubuhinzi, intungamubiri, n’imiti myiza.

Kuzamura ifu neza hamwe na GMP Jet Milling

Mu nganda zigenzurwa cyane nka farumasi n’ibiribwa, gusya indege ya GMP ntabwo yujuje ubuhanga gusa - ni inyungu zo guhatanira. Ubushobozi bwayo bwo gutanga ultra-nziza, idafite umwanda, kandi ifu yuzuye yashyizwe mubikorwa bituma iba uburyo bwizewe kubabikora badasaba ikindi usibye kuba indashyikirwa.

Kuri Qiangdi, duhuza ubumenyi bwinganda bwimbitse nudushyaurusyoikoranabuhanga ryujuje ubuziranenge bwo hejuru ku isi. Waba uri kugabanya ibiyobyabwenge APIs cyangwa gutunganya ibiryo byongera ibiryo bikora, sisitemu yo gusya indege yemewe na GMP itanga isuku, imikorere, nicyizere cyo gukora - igihe cyose.