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ISO 7 GMP Icyumba gisukura imiti

Ibisobanuro bigufi:

Hamwe nuburambe bwimyaka 20 mubikorwa byibyumba bisukuye, twujuje imanza nyinshi mumahanga kwisi. Turashobora gutanga serivisi imwe kuva igenamigambi ryambere kugeza kubikorwa byanyuma mubyumba byawe bisukuye bya farumasi ukurikije amahame mpuzamahanga ISO 14644, GMP, FDA, OMS, nibindi. Reka tunyure mubyumba byanyu bisukuye mugitangira mbere yo kuganira!


Ibicuruzwa birambuye

Ibicuruzwa

Ibisobanuro ku bicuruzwa

Icyumba gisukuye cya farumasi gikoreshwa cyane cyane mumavuta, akomeye, sirupe, gushiramo infusion, nibindi bisanzwe GMP na ISO 14644 mubisanzwe bifatwa muriki gice. Ikigamijwe ni ukubaka ibyumba bya siyansi kandi bidafite isuku ibyumba by’ibidukikije, uburyo, imikorere n’imicungire no kuvanaho burundu ibikorwa byose bishoboka kandi bishoboka by’ibinyabuzima, ivumbi n’umwanda wanduye hagamijwe gukora ibicuruzwa by’ibiyobyabwenge byujuje ubuziranenge n’isuku. Ukwiye kwibanda ku ngingo yingenzi yo kugenzura ibidukikije no gukoresha ikoranabuhanga rishya ryo kuzigama ingufu nkuburyo bwatoranijwe. Iyo birangiye bigenzuwe kandi byujuje ibisabwa, bigomba kwemezwa nubuyobozi bwibiribwa n’ibiyobyabwenge mbere yo gutanga umusaruro. Imiti ya GMP isukura ibyumba byubushakashatsi hamwe nubuhanga bwo kurwanya umwanda nimwe muburyo nyamukuru bwo gushyira mu bikorwa neza GMP. Nkumwuga wicyumba cyumwuga utanga igisubizo, turashobora gutanga GMP serivisi imwe kuva igenamigambi ryambere kugeza kubikorwa byanyuma nkibikorwa byabakozi hamwe nibisubizo bitemba, sisitemu yimiterere yicyumba, sisitemu yicyumba gisukuye HVAC, sisitemu yamashanyarazi yicyumba, sisitemu yo kugenzura ibyumba bisukuye , gutunganya imiyoboro ya sisitemu, hamwe nizindi serivise zishyigikira ibikorwa rusange, nibindi. Turashobora gutanga ibisubizo byibidukikije byubahiriza GMP, Fed 209D, ISO14644 na EN1822 mpuzamahanga, kandi tugakoresha tekinoroji yo kuzigama ingufu.

Urupapuro rwubuhanga

 

 

Icyiciro cya ISO

Igice kinini / m3

Indwara ya bagiteri ireremba cfu / m3

Kubitsa Bagiteriya (ø900mm) cfu / 4h

Ubuso bwa Microorganism

Leta ihagaze

Leta ifite imbaraga

Gukoraho (ø55mm)

cfu / isahani

5 Intoki Zintoki cfu / gants

≥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

sisitemu yicyumba gisukuye

Igice
• Sukura urukuta rw'icyumba n'ikibaho
• Sukura urugi nidirishya
• Sukura umwirondoro wa rom na hanger
Epoxy hasi

icyumba gisukuye hvac

Igice cya HVAC
Igice cyo gutwara ikirere
• Tanga umwuka winjira hanyuma usubize umwuka
Umuyoboro wo mu kirere
• Ibikoresho byo kubika

icyumba gisukuye

Igice c'amashanyarazi 
• Sukura urumuri rw'icyumba
• Hindura na sock
• Insinga n'insinga
• Agasanduku ko gukwirakwiza ingufu

gukurikirana icyumba gisukuye

Igice cyo kugenzura
• Isuku yo mu kirere
• Ubushyuhe n'ubushuhe bugereranije
• Imyuka yo mu kirere
• Umuvuduko utandukanye

Ibisubizo bya Turnkey

igishushanyo mbonera cy'icyumba

Igenamigambi & Igishushanyo
Turashobora gutanga inama zumwuga
nigisubizo cyiza cyubwubatsi.

ibikoresho byo mucyumba gisukuye

Umusaruro & Gutanga
Turashobora gutanga ibicuruzwa byiza
kandi ukore igenzura ryuzuye mbere yo kubyara.

kubaka ibyumba bisukuye

Kwiyubaka & Gukoresha
Turashobora gutanga amakipe yo hanze
kugirango umenye neza imikorere myiza.

gutunganya ibyumba bisukuye

Kwemeza & Amahugurwa
Turashobora gutanga ibikoresho byo kwipimisha kuri
kugera ku gipimo cyemewe.

Ibyerekeye Twebwe

gusukura ibyumba

• Uburambe bwimyaka 20, buhujwe na R&D, gushushanya, gukora no kugurisha;

• Hafi y'abakiriya barenga 200 mu bihugu birenga 60;

• Yemerewe na sisitemu yo kuyobora ISO 9001 na ISO 14001.

icyumba gisukuye

• Sukura icyumba cyumushinga utanga igisubizo;

• Serivisi imwe ihagarara kuva igishushanyo cya mbere kugeza kumikorere yanyuma;

• Imirima 6 yingenzi nka farumasi, laboratoire, elegitoroniki, ibitaro, ibiryo, ibikoresho byubuvuzi, nibindi.

uruganda rukora isuku

• Sukura ibicuruzwa byo mucyumba nuwabitanze;

• Yabonye patenti nyinshi na CE na CQC ibyemezo;

• Ibicuruzwa 8 byingenzi nkibikoresho byicyumba gisukuye, umuryango wicyumba gisukuye, akayunguruzo ka hepa, FFU, agasanduku kanyuzemo, kwiyuhagira ikirere, intebe isukuye, icyumba gipima, nibindi.

Ikigo cy'umusaruro

uruganda rukora isuku
umufana wicyumba
hepa ffu
hepa muyunguruzi
uruganda rukora isuku
igice cya ffu
8
4
2

Kwerekana ibicuruzwa

ikibaho
umuryango w'icyumba gisukuye
Igice cyo gushungura
agasanduku
Laminar
umukungugu
muyunguruzi
agasanduku ka hepa
icyumba cyo gupima

Ibibazo

Q:Umushinga wawe wicyumba gisukuye bizatwara igihe kingana iki?

A:Mubisanzwe ni igice cyumwaka uhereye kubishushanyo mbonera kugeza kubikorwa bigenda neza, nibindi. Biterwa kandi numushinga, aho ukorera, nibindi.

Q:Niki gikubiye mubishushanyo mbonera byicyumba cyawe?

A:Mubisanzwe tugabanya ibishushanyo byacu mubice 4 nkigice cyimiterere, igice cya HVAC, igice cyamashanyarazi nigice cyo kugenzura.

Q:Urashobora gutegura imirimo yubushinwa kurubuga rwo hanze kugirango wubake ibyumba bisukuye?

Igisubizo:Nibyo, tuzabitegura kandi tuzagerageza uko dushoboye kugirango dutsinde VISA.

Q: Ibikoresho byawe byo mucyumba gisukuye bishobora kuba bingana iki?

A:Mubisanzwe ni ukwezi 1 kandi byaba iminsi 45 mugihe AHU iguzwe muriki gikorwa cyicyumba gisukuye.


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