Mu nganda zikora imiti ku isi zigenda zitera imbere vuba, ubuvuzi bwo gutera imiti mu mitsi (IV), nk'ikintu cy'ingenzi mu buvuzi bw'imiti, bwashyizeho amahame akomeye adasanzwe yerekeye umutekano w'imiti, ituze, n'imikorere myiza y'umusaruro. Igikapu cya Multi Chamber IV, gifite imiterere yihariye y'igice cyacyo, gishobora kuvanga imiti n'ibinyabutabire ako kanya, bikanoza cyane uburyo imiti ikoreshwa mu gupfunyika no koroshya imiti. Cyabaye uburyo bwiza bwo gupfunyika mu buryo bugoye nko kugaburira abana, imiti ya chimiotherapie, imiti irwanya udukoko, nibindi. Ariko, gukora ibyo bicuruzwa bisaba ibisabwa bikomeye cyane ku ikoranabuhanga ry'ibikoresho, ibidukikije bisukuye, no kubahiriza amategeko. Abatanga serivisi z'ubuhanga gusa bafite ubumenyi bwinshi mu bya tekiniki n'uburambe ku mishinga ku isi nibo bashobora gutanga ibisubizo byizewe koko.

Nk'umuyobozi mpuzamahanga mu bijyanye n'ubuhanga mu by'ubuvuzi, IVEN Pharmatech Engineering, ifite uburambe bw'imyaka irenga 30 mu nganda zikora imiti, yiyemeje guha abakiriya bo ku isi serivisi z'ubuhanga zidasanzwe kuva ku gushushanya inzira, guhuza ibikoresho kugeza ku kwemeza ko bikurikiza amategeko.Umurongo wo gukora imifuka myinshi y'icyumba cya kaneNtabwo ihuza gusa ikoranabuhanga rigezweho ryo kwikora, ahubwo inafite inyungu nyamukuru yo kubahiriza 100% amabwiriza mpuzamahanga nka EU GMP na US FDA cGMP, bifasha amasosiyete y’imiti gukora neza ibicuruzwa bifite agaciro gakomeye no gukoresha amahirwe yo ku isoko mpuzamahanga.

Umurongo w'Ibikorwa by'Amasashi y'Inzu N ...

Umuyoboro wa IVEN wo gukora udufuka tw’ibirahuri byinshi wagenewe guhangana n’imbogamizi zo gukora ifumbire igoye. Binyuze mu matsinda ane y’ikoranabuhanga rigezweho, ufasha abakiriya guca mu mbogamizi zisanzwe zo gukora:

1. Gutunganya byumba byinshi hamwe n'ikoranabuhanga ryo kuzuza neza
Imifuka gakondo y’icyumba kimwe ikoresha inzira zo kuvanga hanze, ibyo bikaba byatera ibyago byo kwanduzwa n’ibindi kandi ntibikora neza. IVEN ikoresha uburyo bwo gupima ikirere bufite ibice byinshi. Binyuze mu buryo bwo kugenzura ubushyuhe n’ubukonje, ibice 2-4 byigenga bishobora gukorwa mu buryo bumwe, bifite imbaraga zirenga 50N/15mm hagati y’ibyumba, bigatuma nta gusohoka kw’amazi mu gihe cyo gutwara no kubika. Uburyo bwo kuzuza butanga pompe y’amazi ifite imiyoboro myinshi itwarwa na moteri ikoresha ikoranabuhanga rya magnetic levitation linear, ifite ubushobozi bwo kuzuza nibura ± 0.5%, ishyigikira uburyo bwo guhindura kuva kuri 1mL kugeza kuri 5000mL, ihuye neza n’ibikenewe mu gupfunyika ibikomoka ku ruhu bitandukanye nk’ibinyabutabire n’imiti ya chemotherapy.

2. Sisitemu yo guhuza idafite umwanda ifunze neza
Kugira ngo ikibazo cyo kugenzura mikorobe mu dukapu tw’imyuga twinshi twavanzwe mbere, IVEN yakoze igikoresho cya SafeLink ™ Aseptic gifite patenti. Iki gikoresho gikoresha imiterere y’urwego rwo kugabanya ubukana bwa laser, hamwe n’uburyo bwo gutera umuvuduko wa mashini. Abaganga bagomba gukanda ukuboko kumwe gusa kugira ngo bagere ku itumanaho ridafite uburibwe hagati y’imyuga, birinda ibyago by’imyanda y’ibirahure ishobora guterwa na valve zisanzwe zipfunyika. Nyuma yo kugenzura umuntu wa gatatu, imikorere yo gufunga imikoranire ikora yujuje ibipimo bya ASTM F2338-09, kandi amahirwe yo kwinjira kwa mikorobe ni munsi ya 10 ⁻⁶.

3. Sisitemu yo kugenzura no gukurikirana ubuhanga bw'ubukorano
Umuyoboro w’umusaruro uhuza sisitemu yo gutahura ya AI X-ray ifite uburyo bubiri, isuzuma mu buryo bumwe inenge za firime, kuzuza ibinyuranyo by’amazi, no gufunga neza ibyumba binyuze muri kamera za CCD zifite ubushobozi bwo hejuru hamwe n’amashusho ya X-ray yoroshye. Algorithm zo kwiga cyane zishobora kumenya mu buryo bwikora inenge z’umwobo w’inyuma ku rugero rwa 0.1mm, hamwe n’igipimo cyo kumenya kitari cyo kiri munsi ya 0.01%. Muri icyo gihe, buri gakapu gashyirwamo RFID chip kugira ngo haboneke uburyo bwo gukurikirana neza kuva ku bikoresho fatizo, ibipimo by’umusaruro kugeza ku bushyuhe bwo kuzenguruka kw’amazi, byujuje ibisabwa na FDA DSCSA (Drug Supply Chain Safety Act).

4. Uburyo bwo kwirinda indwara zifata igihe kirekire mu buryo bwo kuzigama ingufu
Akabati gasanzwe ko gusukura amazi gakoresha ingufu nyinshi kandi gafite aho kababaza cyane, gakoresha ingufu nyinshi kandi gakora igihe kirekire. IVEN n'abafatanyabikorwa bayo b'Abadage bafatanyije gutegura sisitemu ya Rotary Steam in Place (SIP), ikoresha igishushanyo mbonera cy'umunara uzenguruka kugira ngo ikore imihindagurikire mu cyumba cy'umwuka gishyushye cyane. Ishobora kurangiza gusukura amazi mu minota 15 kuri 121 ℃, igakiza ingufu 35% ugereranije n'uburyo gakondo. Sisitemu ifite icyuma gipima B&R PLC cyikorera, gishobora kwandika no kubika amakuru y'ubushyuhe bwa buri cyiciro (agaciro ka F ₀ ≥ 15), kandi kigakora inyandiko z'ikoranabuhanga zikurikiza 21 CFR Igice cya 11.

Umuhango wa IVEN: umuyoboro wa serivisi ku isi ushingiye ku ntsinzi y'abakiriya

Tuzi neza ko ibikoresho byo mu rwego rwa mbere bigomba guhuzwa na serivisi yo mu rwego rwa mbere.IVEN yashinze ibigo by’ikoranabuhanga mu bihugu 12 ku isi, itanga serivisi zo gusuzuma indwara zikorerwa kure amasaha 7 kuri 24 n’ubufasha bwo gusubiza indwara mu gihe cy’amasaha 48. Itsinda ryacu rishobora gutanga serivisi zihariye nyuma yo kugurisha hashingiwe ku itandukaniro ry’amategeko agenga uturere dutandukanye.

Muri iki gihe cy’ubuvuzi bugezweho n’imiti yihariye, udupfunyika two gutera imiti mu byumba byinshi turimo kuvugurura imipaka y’ubuvuzi bushingiye ku mikorobe. IVEN Pharmatech Engineering yubaka ikiraro cy’ejo hazaza ku bigo by’imiti ku isi kubera ubuhanga bwayo buhebuje mu by’ubuhanga no gukurikirana kubahiriza amategeko. Byaba ari imishinga mishya cyangwa kuvugurura ubushobozi, umurongo wacu w’inzobere mu gukora uzaba umufatanyabikorwa wawe wizeye cyane.

Vugana na IVENitsinda ry'impuguke rihita ritanga ibisubizo byihariye n'inkuru z'intsinzi ku isi!