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He aha nā mea i komo i loko o ka GMP CLEAN ROOM STANDARDS?

lumi maemae
gmp lumi maemae

Nā mea hana hale

1. ʻO nā paia lumi maʻemaʻe GMP a me nā panela kaupaku he 50mm ka mānoanoa o nā panela sandwich, kahi i ʻike ʻia e ka nani a me ka rigidity ikaika.ʻO nā kihi arc, nā puka, nā pā pukaaniani, a me nā mea ʻē aʻe i hana maʻamau i nā kiʻi alumina kūikawā.

2. Hiki ke hana ʻia ka lepo me ka epoxy self-leveling floor a i ʻole ka papa kiʻekiʻe o ka lole pale pale.Inā loaʻa nā koi anti-static, hiki ke koho ʻia ke ʻano anti-static.

3. Ua hana 'ia ka ea a me ka ho'iho'i 'ana me ka thermally bonded zinc sheets a ho'opa'a 'ia me ka flame-retardant PF foam plastic sheets i loa'a ka ho'oma'ema'e maika'i a me nā hopena insulation thermal.

4. ʻO ka pahu hepa i hana ʻia me ka pauka i uhi ʻia i ke kila kila, nani a maʻemaʻe.Hana ʻia ka pā mesh i paʻi ʻia me ka pā alumini pena, ʻaʻole i ʻōpala a pili ʻole i ka lepo a pono e hoʻomaʻemaʻe ʻia.

Nā palena lumi maʻemaʻe GMP

1. Ka helu o nā ventilations: papa 100000 ≥ 15 manawa;papa 10000 ≥ 20 manawa;papa 1000 ≥ 30 manawa.

2. Paʻi ʻokoʻa: hale hana nui i kahi lumi pili ≥ 5Pa

3. Awelika ea velocity: 0.3-0.5m / s ma ka papa 10 a me ka papa 100 lumi maemae;

4. Ka wela: >16 ℃ i ka hoʻoilo;<26 ℃ i ke kauwela;ka loli ± 2 ℃.

5. Haʻahaʻa 45-65%;ʻoi aku ka maikaʻi o ka haʻahaʻa o ka lumi maʻemaʻe GMP ma kahi o 50%;ʻoi aku ka kiʻekiʻe o ka haʻahaʻa o ka lumi maʻemaʻe uila e pale i ka hana ʻana o ka uila paʻa.

6. Noise ≤ 65dB (A);He 10%-30% ka nui o ka nui o ka nui o ka ea;kukui 300 Lux

Nā kūlana mālama ola kino

1. I mea e pale aku ai i ka hoʻohaumia ʻana i loko o ka lumi maʻemaʻe GMP, pono e hoʻolaʻa ʻia nā mea hana no ka lumi maʻemaʻe e like me nā ʻano huahana, nā koi kaʻina, a me nā pae hoʻomaʻemaʻe ea.Pono e hoʻokomo ʻia ka ʻōpala i loko o nā ʻeke lepo a lawe ʻia i waho.

2. Pono e hoʻomaʻemaʻe i ka lumi maʻemaʻe GMP ma mua o ka holo ʻana a ma hope o ka pau ʻana o ka hana hana;pono e hoʻomaʻemaʻe i ka wā e holo ana ka ʻōnaehana ea o ka lumi maʻemaʻe;ma hope o ka pau ʻana o ka hana hoʻomaʻemaʻe, pono e hoʻomau ka ʻōnaehana hoʻomaʻemaʻe ea a hiki i ka hoʻihoʻi ʻia ʻana o ka pae maʻemaʻe i ʻōlelo ʻia.ʻAʻole pōkole ka manawa hana hoʻomaka ma mua o ka manawa hoʻomaʻemaʻe ponoʻī o ka lumi maʻemaʻe GMP.

3. Pono e hoʻololi pinepine ʻia nā disinfectants i mea e pale ai i nā microorganism mai ka hoʻomohala ʻana i ka lāʻau kūʻē.Ke hoʻoneʻe ʻia nā mea nui i loko o ka lumi maʻemaʻe, pono e hoʻomaʻemaʻe mua ʻia me kahi mea hoʻomaʻemaʻe i loko o kahi ʻano maʻamau, a laila e ʻae ʻia e komo i loko o ka lumi maʻemaʻe no ka mālama hou ʻana me kahi lumi hoʻomaʻemaʻe a holoi ʻana paha;

4. Ke pau ka ʻōnaehana lumi maʻemaʻe GMP, ʻaʻole ʻae ʻia nā mea nui e hoʻoneʻe i loko o ka lumi maʻemaʻe.

5. Pono e hoʻomaʻemaʻe ʻia ka lumi maʻemaʻe GMP a hoʻomaʻemaʻe ʻia, a hiki ke hoʻohana ʻia ka hoʻomaʻemaʻe wela maloʻo, ka hoʻomaʻemaʻe wela wela, ka hoʻoheheʻe ʻana i ka radiation, ka sterilization kinoea, a me ka disinfectant disinfection.

6. ʻO ka hoʻomaʻamaʻa ʻana i ka radiation ka mea kūpono no ka sterilization o nā mea wela a i ʻole nā ​​​​huahana, akā pono e hōʻoia ʻia ʻaʻole ʻino ka radiation i ka huahana.

7. He hopena bactericidal ka disinfection radiation ultraviolet, akā nui nā pilikia i ka wā hoʻohana.ʻO nā kumu he nui e like me ka ikaika, ka maʻemaʻe, ka haʻahaʻa o ke kaiapuni a me ka mamao o ke kukui ultraviolet e hoʻopilikia i ka hopena disinfection.Eia kekahi, ʻaʻole kiʻekiʻe kona hopena disinfection a ʻaʻole kūpono.No kēia mau kumu, ʻaʻole ʻae ʻia ka disinfection ultraviolet e ka GMP haole ma muli o ka wahi e neʻe ai ka poʻe a ma kahi e kahe ai ka ea.

8. Pono ka ho'oma'ama'a 'ana i ka Ultraviolet i ka irradiation lō'ihi o nā mea i 'ike 'ia.No ka irradiation o loko, ke koi ʻia ka helu sterilization e hiki i 99%, ʻo ka nui o ka irradiation o ka bacteria maʻamau e pili ana i 10000-30000uw.S/cm.ʻO ke kukui ultraviolet 15W 2m ka mamao mai ka honua aku he 8uw/cm ka ikaika o ka hoʻomālamalama, a pono e hoʻomālamalama ʻia no kahi hola 1.I loko o kēia hola 1, ʻaʻole hiki ke komo i ka wahi i hoʻomālamalama ʻia, inā ʻaʻole ia e hōʻino pū i nā ʻili kanaka me ka hopena carcinogenic maopopo.


Ka manawa hoʻouna: Nov-16-2023