Purification Room is also called as Clean Room. It means the dust and microorganisms level must be under the allowed number.
The clean room is a sealed space. All persons must change to the special cloth when go into the clean room. All equitpments and raw materials need also be treated according to the procedure to be moved in. The finished products will be packed and sealed inside and then be moved out.
The clean room level has a few standard. In pharamceutical packaging manufacturing, the level is 100,000 normally. In biological test laboratory, the level is better 10,000. The main standards of 100,000 and 10,000 level are listed below.
100,000 level clean room standard
| Dust counting, ≥ 0.5μm: | particle upper limit UCL <=3,500,000 per M3 (purfication production rooms) |
| Dust counting, ≥ 5μm: | particle upper limit UCL <=20,000 per M3 (purfication production rooms) |
| Sedimentation bacteria: | ≤ 10 per (dia 90mm.0.5h)(purfication production rooms) |
10,000 level clean room standard
| Dust counting, ≥ 0.5μm: | particle upper limit UCL <=350,000 per M3 (microbiological lab) |
| Dust counting, ≥ 5μm: | particle upper limit UCL <=2,000 per M3 (microbiological lab) |
| Sedimentation bacteria: | ≤ 3 per (dia 90mm.0.5h)(microbiological lab) |
The way to control the cleanness is air changing (filter is used) and the pressure difference between inside and outside the clean rooms. Normally the air changing time need 20 times per hour and the pressure inside should be at least 10 Pa more than outside.
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