• chikwangwani_cha tsamba

Kodi ndi zinthu ziti zomwe zili mu GMP Clean Room Standards?

chipinda choyera
chipinda choyera cha gmp

Zipangizo zomangira

1. Makoma ndi denga la chipinda choyera cha GMP nthawi zambiri amapangidwa ndi ma sandwich panels okhuthala a 50mm, omwe amadziwika ndi mawonekedwe okongola komanso kulimba kwamphamvu. Makona a arc, zitseko, mafelemu a zenera, ndi zina zotero nthawi zambiri amapangidwa ndi ma profiles apadera a alumina.

2. Pansi pake pakhoza kupangidwa ndi pansi yodziyimira yokha ya epoxy kapena pansi yapulasitiki yolimba kwambiri. Ngati pali zofunikira zotsutsana ndi static, mtundu wotsutsana ndi static ungasankhidwe.

3. Mpweya ndi njira zobwezeretsera mpweya zimapangidwa ndi mapepala a zinc ogwirizana ndi kutentha ndipo amamatidwa ndi mapepala apulasitiki a PF omwe amaletsa moto omwe ali ndi mphamvu zoyeretsa bwino komanso zoteteza kutentha.

4. Bokosi la hepa limapangidwa ndi chimango chachitsulo chopakidwa ufa, chomwe ndi chokongola komanso choyera. Mbale ya maukonde obowoledwa imapangidwa ndi mbale ya aluminiyamu yopakidwa utoto, yomwe siichita dzimbiri kapena kumamatira ku fumbi ndipo iyenera kutsukidwa.

Magawo a chipinda choyera cha GMP

1. Chiwerengero cha ma air conditioner: kalasi 100000 ≥ nthawi 15; kalasi 10000 ≥ nthawi 20; kalasi 1000 ≥ nthawi 30.

2. Kusiyana kwa kuthamanga kwa magazi: malo ogwirira ntchito akuluakulu ndi chipinda chapafupi ≥ 5Pa

3. Liwiro la mpweya wapakati: 0.3-0.5m/s pa chipinda choyera cha kalasi 10 ndi chipinda choyera cha kalasi 100;

4. Kutentha: >16℃ m'nyengo yozizira; <26℃ m'chilimwe; kusinthasintha ±2℃.

5. Chinyezi 45-65%; chinyezi mu chipinda choyera cha GMP chimakhala pafupifupi 50%; chinyezi mu chipinda choyera chamagetsi chimakhala chokwera pang'ono kuti tipewe kupanga magetsi osasinthasintha.

6. Phokoso ≤ 65dB (A); kuchuluka kwa mpweya watsopano ndi 10%-30% ya kuchuluka konse kwa mpweya; kuunikira 300 Lux

Miyezo yoyendetsera zaumoyo

1. Pofuna kupewa kuipitsidwa kwa malo oyeretsera a GMP, zida zoyeretsera chipinda ziyenera kuperekedwa malinga ndi mawonekedwe a chinthucho, zofunikira pa ntchitoyo, komanso kuchuluka kwa kuyeretsa mpweya. Zinyalala ziyenera kuyikidwa m'matumba a fumbi ndikuchotsedwa.

2. Kuyeretsa chipinda choyera cha GMP kuyenera kuchitika musanayambe ulendo wopita kuntchito komanso ntchito yopangira itatha; kuyeretsa kuyenera kuchitika pamene makina oziziritsira mpweya m'chipinda choyera akugwira ntchito; ntchito yoyeretsa ikatha, makina oziziritsira mpweya ayenera kupitiriza kugwira ntchito mpaka mulingo woyeretsera womwe watchulidwa utabwezeretsedwa. Nthawi yoyambira ntchito nthawi zambiri siifupi kuposa nthawi yodziyeretsera yokha ya chipinda choyera cha GMP.

3. Mankhwala ophera tizilombo toyambitsa matenda omwe amagwiritsidwa ntchito ayenera kusinthidwa nthawi zonse kuti tizilombo toyambitsa matenda tisamavutike ndi mankhwala. Zinthu zazikulu zikamasamutsidwa m'chipinda choyera, ziyenera kutsukidwa ndi chotsukira vacuum pamalo abwinobwino, kenako n’kuloledwa kulowa m’chipinda choyera kuti akachiritsidwenso ndi chotsukira vacuum choyera kapena njira yopukutira;

4. Pamene dongosolo la chipinda choyera cha GMP silikugwira ntchito, zinthu zazikulu siziloledwa kusunthidwa kupita kuchipinda choyera.

5. Chipinda choyera cha GMP chiyenera kutsukidwa ndi kutsukidwa, ndipo kutsukidwa ndi kutentha kouma, kutsukidwa ndi kutentha konyowa, kutsukidwa ndi radiation, kutsukidwa ndi gasi, ndi kutsukidwa ndi tizilombo toyambitsa matenda kungagwiritsidwe ntchito.

6. Kuyeretsa pogwiritsa ntchito radiation ndikofunikira kwambiri poyeretsa zinthu kapena zinthu zomwe zimakhudzidwa ndi kutentha, koma ziyenera kutsimikiziridwa kuti kuwalako sikuvulaza chinthucho.

7. Kupha tizilombo toyambitsa matenda pogwiritsa ntchito ma radiation a ultraviolet kumayambitsa matenda enaake a bakiteriya, koma pali mavuto ambiri pakugwiritsa ntchito. Zinthu zambiri monga mphamvu, ukhondo, chinyezi cha chilengedwe komanso mtunda wa nyali ya ultraviolet zimakhudza momwe imapha tizilombo toyambitsa matenda. Kuphatikiza apo, mphamvu yake yopha tizilombo toyambitsa matenda si yayikulu ndipo siyoyenera. Pazifukwa izi, kupha tizilombo toyambitsa matenda pogwiritsa ntchito ma ultraviolet sikuvomerezedwa ndi GMP yakunja chifukwa cha malo omwe anthu amasunthira komanso komwe mpweya umatuluka.

8. Kuyeretsa kwa Ultraviolet kumafuna kuwala kwa nthawi yayitali kwa zinthu zomwe zawonekera. Pa kuwala kwa mkati, pamene kuchuluka kwa kuwala kukufunika kufika pa 99%, mlingo wa kuwala kwa mabakiteriya wamba ndi pafupifupi 10000-30000uw.S/cm. Nyali ya ultraviolet ya 15W yomwe ili pamtunda wa mamita 2 kuchokera pansi ili ndi mphamvu ya kuwala ya pafupifupi 8uw/cm, ndipo imafunika kuwala kwa pafupifupi ola limodzi. Mkati mwa ola limodzi ili, malo owala sangalowemo, apo ayi adzawononganso maselo a khungu la anthu ndi zotsatira zodziwikiratu za khansa.


Nthawi yotumizira: Novembala-16-2023