ISO 7 GMP Icyumba gisukuye
Ibisobanuro by'ibicuruzwa
Icyumba gisukuye cya farumasi gikoreshwa cyane mu mavuta, gikomeye, sirupe, gushiramo, nibindi 14644 bisanzwe bisuzumwa muri uyu murima. Intego ni ukubaka ibyumba bya siyanse kandi bikomeretsa, imikorere na sisitemu yo gucunga neza ibikorwa byose bishoboka kandi bishobora kwanduza umukungugu kugirango ukore ibicuruzwa byikigereranyo byisumbuye kandi byisuku. Igomba kwibanda ku ngingo y'ingenzi yo kugenzura ibidukikije no gukoresha tekinoroji nshya yo kuzigama ingufu nkuko byahisemo. Iyo amaherezo bigenzuwe kandi byujuje ibisabwa, bigomba kwemezwa nubuyobozi bwibiyobyabwenge byaho mbere yo gutanga umusaruro. GMP Farumasili yimiti yubuhanga bwibisubizo hamwe nikoranabuhanga ryo kugenzura umwanda nimwe muburyo bukomeye bwo kwemeza ishyirwa mubikorwa rya GMP. Nkumwanya mwiza wumwuga utanga igisubizo, turashobora gutanga GMPE-guhagarika GMP kuva igenamigambi ryambere kubikorwa byanyuma nkibisubizo bya sisitemu ya HVAC, Icyumba gisukuye, sisitemu yo gukurikirana ibyumba , sisitemu yo gutunganya imiyoboro, hamwe nibindi bikorwa byo gushyigikira muri rusange, nibindi turashobora gutanga ibisubizo byibidukikije byubahiriza GMP, Fed 209D, ISO1462 hamwe nubuziranenge mpuzamahanga, kandi birasaba Ikoranabuhanga rimeza ingufu.
Urupapuro rwamakuru
|
ISO | Ibice byinshi / m3 |
Ireremba ya bagiteri cfu / m3 |
Kubika Bagiteri (Ø900mm) CFU / 4H | Microorganism yo hejuru | ||||
| Leta ihamye | Leta | Gukoraho (Ø55mm) CFU / AMAFARANGA | Inkomoko 5 y'urutoki CFU / GATANDA | |||||
| ≥0.5 μm | ≥5.0 μm | ≥0.5 μm | ≥5.0 μm | |||||
| ISO 5 | 3520 | 20 | 3520 | 20 | <1 | <1 | <1 | <1 |
| ISO 6 | 3520 | 29 | 352000 | 2900 | 10 | 5 | 5 | 5 |
| ISO 7 | 352000 | 2900 | 3520000 | 29000 | 100 | 50 | 25 | / |
| ISO 8 | 3520000 | 29000 | / | / | 200 | 100 | 50 | / |
Ibisobanuro birambuye
Imiterere
• Gusukura Urukuta hamwe na Panel
• gusukura umuryango wicyumba nidirishya
• Sukura umwirondoro wa Rom na Hanger
• epoxy hasi
HVAC Igice
Igice cyo gukemura ikirere
• gutanga uruzitiro rwindege hanyuma usubize indege
• Umuyoboro wo mu kirere
• Ibikoresho byo kugenzura
Igice cy'amashanyarazi
• Icyumba gisukuye
• Hindura kandi sock
• insinga n'umugozi
Agasanduku k'ingufu
Kugenzura igice
• isuku mu kirere
• ubushyuhe nubushuhe ugereranije
• umwuka
• igitutu gitandukanye
Ibisubizo byamazi
Gutegura & Igishushanyo
Turashobora gutanga inama zumwuga
na Politiki nziza yubuhanga.
Umusaruro & Gutanga
Turashobora gutanga ibicuruzwa-byiza
kandi ukore ubushakashatsi bwuzuye mbere yo kubyara.
Kwishyiriraho & Gutanga
Turashobora gutanga amakipe yo mumahanga
kugirango umenye neza ibikorwa byiza.
Kwemeza & Amahugurwa
Turashobora gutanga ibikoresho byo kugerageza kuri
kugera kubipimo byemewe.
Ibyacu
• Uburambe bwimyaka 20, ihuriweho na R & D, igishushanyo, ingaragu no kugurisha;
• yakusanyije abakiriya barenga 200 mu bihugu birenga 60;
• Yemerewe na ISO 9001 na ISO 14001 sisitemu yo kuyobora.
• Gusukura icyumba cyumushinga utanga ibicuruzwa;
• Serivise imwe yahagaritswe kuva ishushanya ryambere mubikorwa byanyuma;
• Imirima 6 nyamukuru nka faruzi, laboratoire, elegitoronike, ibitaro, ibiryo, igikoresho cyubuvuzi, nibindi
• Gusukura icyumba cyo gukora ibicuruzwa hamwe nuwabitanze;
• Kubona patenti nyinshi kandi CE na CQC ibyemezo;
• Ibicuruzwa 8 nyamukuru nka Panel Icyumba Cyiza, Urugi rwicyumba, Hepa Muyunguruzi, FFU, Gusunika Isanduku, Gupima ikirere, Ibiti bisukuye, nibindi
Ikigo
Ibicuruzwa byerekana
Ibibazo
Q:Umushinga wawe w'icyumba wawe usukuye uzagutwara igihe kingana iki?
A:Mubisanzwe ni umwaka wigice uhereye kubanjirije ibikorwa byatsinze, nibindi kandi biterwa nubuso bwumushinga, urwego rwakazi, nibindi
Q:Ni ibiki bikubiye mu cyumba cyawe cyiza?
A:Mubisanzwe tugabanya ibishushanyo mbonera byigishushanyo mbonera 4 nkuko imiterere yigice, igice cya HVAC, igice cyamashanyarazi no kugenzura.
Q:Urashobora gutegura imirimo yubushinwa kurubuga rwo hanze kugirango ukore ibyumba bisukuye?
Igisubizo:Nibyo, tuzabitegura kandi tuzagerageza uko dushoboye kugirango dusabe viza.
Q: Ibikoresho n'ibikoresho byawe bisukuye bishobora kuba byiteguye igihe kingana iki?
A:Mubisanzwe ni ukwezi 1 kandi byaba iminsi 45 niba Ahu yaguzwe muri uyu mushinga wera.
