Inganda zikora imiti zisaba igenzura rikomeye ry’ibidukikije kugira ngo habeho ireme ry’ibicuruzwa, ubuziranenge, no kubahiriza amategeko. Muri izo ngamba zose, urwego rw’ubushuhe bukwiye ni ingenzi cyane.Imashini zikuraho ubushuhe mu mitina sisitemu zo gukuraho ubushuhe mu miti bigira uruhare runini mu gukumira ingaruka z'ubushuhe bushobora gutera kwanduzwa na mikorobe, kwangirika kw'imiti, no gutakaza imbaraga z'imiti. Iki gice kivuga ku mpamvu kugenzura ubushuhe ari ingenzi cyane mu nganda z'imiti, icyo imiti igabanya ubushuhe mu miti ikoreshwa cyane, n'uburyo bwo kubona sisitemu ikwiriye ikigo cyawe.

Impamvu kugenzura ubushyuhe n'ubushuhe ari ingenzi muri farumasi

Gukora imiti bisaba ikirere gicungwa neza cyane. Ubushuhe bwinshi butuma habaho:

Gabanura ibicuruzwa– Amazi agabanya ibigize imiti, bigatuma igabanuka.

Ikura ry'ibihumyo na bagiteri– Ibihumyo na bagiteri bikura vuba iyo hari ubushuhe bwinshi kandi bishobora gukurira ahantu handuye.

Kwangirika kw'ibipfunyika– Ibirango n'udupfunyika tw'udusimba birangirika kandi bigasenyuka ahantu hari ubushuhe bwinshi.

Raporo y’Ishami ry’Umuryango w’Abibumbye ryita ku Buzima (OMS) ivuga ko hafi 20% by’imiti isubizwa mu kazi ikomoka ku kudashobora kugenzura ibidukikije, ni ukuvuga kutagira uburyo bwo kugenzura ubushuhe. Kugura imiti ivura ubushuhe mu buryo bwiza ni igikorwa gikomeye cyo kugera ku bikorwa byiza byo gukora (GMP) hamwe no kubahiriza amategeko ya FDA/EMA.

Porogaramu za sisitemu yo gukuraho ubushuhe muri farumasi

Imashini zikuraho ubushuhe mu mikorere ya farumasi zikoreshwa mu bice bike by’ingenzi:

1. Inganda z'imiti

Ibikoresho bikora imiti (APIs) n'ibindi bikoresho bifasha mu gukora imiti ni hygroscopic. Ibikoresho byo gukuraho ubushuhe mu miti bitanga ahantu hadakomeye ho guhumeka (hafi 30-50% bya RH) kugira ngo birinde gupfunyika, amazi abira, no gutakaza imbaraga.

2. Ibigega byo kubikamo ibintu

Ubushuhe bugenzurwa ni ngombwa kugira ngo imiti myinshi ibikwe. Ibikoresho byakuwemo amazi nka penisiline na asipirine bisaba ko bibikwa mu buryo bwumye kugira ngo bibe bihamye. Ubusanzwe ibikoresho bikuraho ubushuhe mu byuma bikoreshwa mu buvuzi bishyirwa mu byumba binini byo kubikamo amazi kugira ngo bibungabunge ubushuhe bw'amasaha 24.

3. Ishami rishinzwe gupakira

Ubushuhe bwangiza udupaki tw'udupira, ibyapa, n'amakarito. Gukuraho ubushuhe birinda kole no kwangirika kw'udupaki, bigatuma ibicuruzwa bigumana ubuzima bwose.

4. Ibyumba byo gusukura no muri laboratwari

Ibyumba byo gusukura bisukuye bigomba kubikwa ahantu hashyushye cyane (munsi ya 40% RH) kugira ngo hirindwe kwanduzwa na mikorobe no gusohora amazi akoresha amashanyarazi (ESD), byangiza ibice by'ikoranabuhanga byoroshye.

Uburyo bwo guhitamo imashini ivura ubushuhe ikwiye mu miti

Ibikoresho bikwiye byo gukuraho ubushuhe mu miti bishingiye ku bintu bitandukanye:

1. Ubushobozi n'uburyo bwo gukwirakwiza amakuru

Barura ingano y'ubushuhe bugomba gukurwamo (mu bipimo ku munsi cyangwa litiro ku munsi).

Tekereza ingano y'icyumba, igipimo cy'ivunjisha ry'umwuka, n'umuvuduko w'ubushuhe (urugero, abagikoresha, ibikoresho).

2. Gukoresha neza ingufu

Koresha ibikoresho byo gukuraho ubushuhe bifite inyenyeri y'ingufu kugira ngo ubone ikiguzi cyo gukora gito. Ibikoresho byo gukuraho ubushuhe bigomba gukoreshwa mu gihe ubushuhe buke cyane, mu gihe ibikoresho byo kongeramo ubushyuhe bishobora gukoreshwa mu gihe cy'ikirere giciriritse.

3. Gukurikiza amahame ngenderwaho y'inganda

Menya neza ko sisitemu yujuje ibisabwa na ISO 14644 (ibipimo ngenderwaho by’icyumba cyo gusukura), FDA, na GMP. Hariho imiti ikuraho ubushuhe irimo HEPA kugira ngo itange umwuka mwiza.

4. Kuramba no Kudakomeza Gufata neza

Ibikoresho by'icyuma kidashonga cyangwa kidashonga ni ingenzi kugira ngo bikoreshwe igihe kirekire. Gusukura ibyuma no koza ibyuma mu gihe runaka bituma bikora neza cyane.

5. Guhindura no guhindura ibintu mu buryo butandukanye

Utwuma duto cyane two gukuraho ubushuhe bwinshi mu nyubako nini dushobora gukorwa hamwe n’ibikoresho byo kugenzura byo hagati kugira ngo bihuze na sisitemu ya HVAC mu buryo bwikora.

Ibyiza byo gukoresha imiti igabanya ubushuhe mu bucuruzi

Kugura imashini igabanya ubushuhe mu miti ku bwinshi bifite akamaro gakurikira:

Ikiguzi cyagabanutse - Kugura ku bwinshi bigabanya ikiguzi kuri buri gikoresho.

Guhuza - Uburyo bumwe ku bimera bitandukanye butanga urwego rumwe rwo kugenzura ubushuhe.

Uburyo bwo kwaguka – Ubushobozi bwo gukuraho ubushuhe bushobora kongerwa byoroshye binyuze mu kongera ingano y'umusaruro.

Abayobozi b'inganda nka Bry-Air, Munters, na DRI-STEEM batanga imiti yo mu rwego rwo hejuru.

Umwanzuro

Imashini zikuraho ubushuhe mu miti zishinzwe imikorere myiza, umutekano, n'ubuziranenge bw'imiti. Kuva ku musaruro kugeza ku gupakira ndetse no ku bwinshi bw'ibicuruzwa,sisitemu zo gukuraho ubushuhe mu mitigutanga uburyo bwo kugenzura neza ubushuhe kugira ngo birinde ibicuruzwa bishobora kwangirika. Ubushobozi, ikoreshwa ry'ingufu, no kubahiriza amabwiriza bigomba kwitabwaho mu guhitamo sisitemu. Ku bikorwa byinshi, imashini zikuraho ubushuhe mu bucuruzi zitanga igisubizo gihendutse kandi cyoroshye. Gushora imari mu bikoresho bikwiye byo gukura ubushuhe mu bicuruzwa ntibituma gusa ibicuruzwa biguma neza ahubwo binatanga imikorere myiza mu nganda zikora imiti.

Binyuze mu gukoresha imiti igezweho cyane ikuraho ubushuhe mu miti, abakora imiti bashobora gukuraho ingaruka, kugabanya ubusa, no gutanga umusaruro mwiza w’imiti.