I-Bioreactor
I-VEN ihlinzeka ngezinsizakalo zobuchwepheshe ekwakhiweni kobunjiniyela, ukucubungula nokukhiqiza, ukuphathwa kwephrojekthi, ukuqinisekiswa, kanye nensizakalo yokuthengisa ngemuva kokuthengisa. Ihlinzeka izinkampani ze-biopharmaceutical ezifana nemithi yokugoma, imishanguzo ye-monoclonal antibody, imithi ye-protein recombinant, nezinye izinkampani ze-biopharmaceutical ngomuntu ngamunye kusuka elabhorethri, ukuhlolwa komshayeli kuya esikalini sokukhiqiza. Uhla olugcwele lwama-mammalian cell culture bioreactors kanye nezixazululo zobunjiniyela ezisha. Ukuklanywa nokukhiqizwa kwama-bioreactors alandela ngokuqinile imithetho ye-GMP kanye nezimfuneko ze-ASME-BPE, kwamukele umklamo ochwepheshile, osebenziseka kalula, osetshenziswayo, kanye nezinhlanganisela zedizayini eziphelele nezivumelana nezimo ukuze kuhlangatshezwane nezidingo zesiko leqoqo lamaseli.
Yakhiwe iyunithi yethangi, iyunithi eshukumisayo, iyunithi yokulawula izinga lokushisa lejazi, iyunithi ye-air inlet yezindlela ezine, iyunithi yokukhipha umoya, iyunithi yokudla nokugcwalisa, iyunithi yokusampula nokuvuna, iyunithi yokulawula ezishintshayo kanye neyunithi evamile ephakathi. Uhlelo lokuzithiba luhambisana nendinganiso yamazwe ngamazwe ye-S88, enesakhiwo esicacile, ukuqoshwa kwedatha yomlando ephelele, ukugcinwa, ukuphatha, ukuboniswa kwegrafu ethrendayo kanye nemisebenzi yokuhlaziya idatha yokuqeqeshwa, ngokuhambisana ne-GAMP5; umsebenzi wokulandela umkhondo (irekhodi le-elekthronikhi/isiginesha ye-elekthronikhi), ngokuhambisana ne-CFR 21 PART11.
Umkhiqizo ulungele isiko lokumiswa ngokugcwele, isiko lokuthwala amashidi kanye nesiko le-microcarrier lemithi yebhayoloji enjengamasosha omzimba kanye nemithi yokugoma (njengomuthi wokugomela amarabi, i-FMD) neminye imithi yebhayoloji esikalini sokuhlola nokukhiqiza.
