Gukoresha uburyo bwo kugenzura imiterere y'umwuka ufunze: Uburyo bwo guhitamo ibyuma byemewe bipima ibipimo bya CE

Mu nganda zigenzurwa cyane nka farumasi, ibiryo n'ibinyobwa, ndetse n'inganda zikora ibikoresho by'ubuvuzi, umwuka ufunze ni ingenzi cyane. Ariko, ni n'ikintu gishobora gutera ubwandu. Ku bashinzwe amasoko n'amatsinda ashinzwe kugenzura ubuziranenge, gukoresha urusobe rw'amahame mpuzamahanga agenga ubuziranenge bw'umwuka si itegeko gusa; ni uburyo bw'ingenzi bwo kwirinda gusubizwa amafaranga menshi no gucibwa amande ahenze.

Gusobanura ibisabwa kuri ISO

Igipimo ngenderwaho ku isi cyo kugabanya ubuziranenge bw'umwuka ufunze ni ISO 8573-1, ishyira mu byiciro ubuziranenge bw'umwuka hashingiwe ku bunini bw'uduce duto, ubushuhe, n'ingano y'amavuta. Urugero, kugera ku buziranenge bw'icyiciro cya mbere bisaba urwego rw'amavuta ari munsi ya 0.01 mg/m³. Muri Amerika, amabwiriza ya FDA na Current Good Manufacturing Practices (cGMP) ategeka ko ibintu byose bikoreshwa mu mwuka ufunze bigomba kuba bidafite burundu ibintu byanduye by'ibinyabuzima n'ibinyabutabire. Ibi akenshi bisaba kuyungurura umwuka ufunze neza bishobora kugera ku bushobozi bwo gukuraho uduce duto kugeza kuri mikoroni 0.01.

Guhitamo Sisitemu yo kuyungurura yemewe neza

Guhitamo icyuma gipima micron gusa ni ikibazo gikunze kubaho. Gukurikiza amategeko nyayo bisaba imikorere yemejwe. Mu gushaka icyuma gipima ibidukikije bigenzurwa, reba ibi bikurikira:

• Isuzuma ryemewe:Menya neza ko uruganda rutanga raporo z'ibizamini by'abandi bigaragaza ko binoze mu kuyungurura.
• Ubuziranenge butagira umwanda:Kugira ngo ibicuruzwa bihuzwe neza, ibyuma bigomba gutsinda ibizamini bikomeye by’ubuziranenge, nka Bubble Point Test, kugira ngo hatagira mikorobe zisohoka.
• Umutekano w'ibikoresho:Ibikoresho byose byo kuyungurura n'imigozi bigomba kuba bikoze mu bikoresho byemewe na FDA, bitari uburozi, bishobora kwihanganira gusukurwa burundu mu mwuka udasanzwe ariko ntibiyongere.

Gukorana n'impuguke mu kubahiriza amategeko

Kugera kuri aya mahame akaze bisaba ibirenze kataloge gusa; bisaba ubuhanga mu bya tekiniki. Gukorana n'uruganda rusobanukiwe ibijyanye n'ubwubatsi n'amategeko bituma ikigo cyawe gikomeza gukora igenzura.

Shinganyiriza iyubahirizwa ryawe uyu munsi
Ntugashyire mu kaga icyemezo cy'ikigo cyawe mu gihe cyo kuyungurura kitagenzuwe.Sura urubuga rwacu kugira ngo urebe amakuru yacu yerekeye icyemezo. Hamagara itsinda ryacu ry’abatekinisiye uyu munsi kugira ngo muganire ku bisabwa n’amategeko kandi muhuzwe n’ibisubizo byemewe kandi bifite imikorere myiza bitanga amahoro yo mu mutima.