Umurongo wo gukora Ampoule naumurongo wuzuye. Kubintu byombi bifunze umunwa kandi bifunguye umunwa, dutanga imirongo ya ampule y'amazi. Dutanga byombi byikora byikora na kimwe cya kabiri cyikora ampoule yuzuza imirongo, ikwiranye numurongo muto wuzuye ampule. Ibikoresho byose mumirongo yuzuza byikora byahujwe kuburyo bikora nka sisitemu imwe, ihuza. Kugirango cGMP yubahirize, ibice byose byitumanaho byubatswe mubikoresho byemewe na FDA cyangwa ibyuma bitagira umwanda 316L.

Automatic Ampoule Yuzuza Umurongo

Automatic Ampoule Yuzuza Imirongobigizwe n'imashini zo kuranga, kuzuza, gufunga, no gukaraba. Imashini yose ihujwe no gukora nka sisitemu imwe, ihuza. Automation ikoreshwa mubikorwa byo gukuraho intervention yabantu. Iyi mirongo izwi kandi nka Production Scale Ampoule Yuzuza Imirongo cyangwa Imirongo Yihuta Yihuta. Ibikoresho muri ubu bwoko bwo kuzuza urutonde hepfo:

Imashini yo gukaraba Ampoule

Intego yo gukaraba ampule yikora, izwi kandi nka animashini imesa ampoule,ni ugusukura ampules mugihe ugabanya ibice byimashini guhuza na ampules kugirango ukurikize amabwiriza ya cGMP. Gukaraba neza kwa ampoule byemezwa na mashini ifite sisitemu ya Gripper yateye imbere ifata ampule mu ijosi ikayihindura kugeza igihe cyo gukaraba kirangiye. Ampule noneho irekurwa kuri sisitemu yibiryo byihuta mumwanya uhagaze nyuma yo gukaraba. Ukoresheje ibice byasimbuwe, imashini irashobora kweza ampules kuva kuri mililitiro 1 kugeza kuri 20.

Umuyoboro wa Sterilisation

Ampule amadirishya hamwe nudukono twahanaguweho sterisile na depyrogene kumurongo ukoresheje umuyoboro wa sterilisation na depyrogenation, uzwi kandi nka farumasisterilizing tunnel. Ampules hamwe nudusanduku twimurwa tuvuye mumashini imesa yikora (idafite sterile) yerekeza kumurongo woherejwe (akarere ka sterile) mumurongo unyuze mumashanyarazi.

Imashini yuzuza no gufunga imashini

Imiti y ibirahuri ya farumasi yuzuye kandi ipakirwa ukoresheje animashini yuzuza no gufunga imashini, bizwi kandi nkuzuza ampoule. Amazi asukwa muri ampules, hanyuma akajyanwa hanze akoresheje gaze ya azote hanyuma agafungwa na gaze yaka. Imashini ifite pompe yuzuye yakozwe kugirango yuzuze amazi neza mugihe uhuza ijosi mugihe cyo kuzuza. Amazi akimara kuzuzwa, ampule irafunzwe kugirango wirinde kwanduza. Yakozwe hubahirizwa amabwiriza ya cGMP ukoresheje ibyuma bitagira ibyuma 316L.

Imashini yo kugenzura Ampoule

Ampule amadirishya ashobora guterwa irashobora kugenzurwa ukoresheje imashini isuzuma ampule. Inzira enye zaImashini yo kugenzura Ampoulebikozwe mumurongo wa nylon-6, kandi bazanye inteko izunguruka irimo AC Drive Rejection Units hamwe na 24V DC. Byongeye kandi, ubushobozi bwo guhindura umuvuduko byashobokaga hamwe na disiki ihindagurika ya AC. Ibice byose byo guhuza imashini bigizwe na polimeri yemewe yemewe nicyuma kidafite ingese, hubahirijwe amabwiriza ya cGMP.

Imashini iranga Ampoule

Ibikoresho byo mu rwego rwo hejuru, bizwi nka animashini yerekana ibimenyetsocyangwa ampoule labeler, ikoreshwa mukirango ibirahuri by'ibirahure, vial, n'amacupa atonyanga amaso. Gucapa icyiciro, itariki yo gukora, nandi makuru kuri labels, shyira printer kuri mudasobwa yawe. Ubucuruzi bwa farumasi bufite uburyo bwo kongeramo barcode yogusuzuma hamwe na sisitemu yo kureba. Hariho ubwoko butandukanye bwibirango bushobora gukoreshwa, harimo impapuro zanditseho, ibirango bibonerana, hamwe na BOPP ibirango hamwe nubwoko bwiziritse.