510K Clear

K162387/K162648

​​Top Premium Quality

   -- by LEAN

          -- by Zero Defect                    

                -- by UWELL

New ISO 8 class clean room accomplished
Source: | Author:Tao | Published time: 2016-09-01 | 2999 Views | Share:
After almost one year's constructing, our new ISO 8 class (100,000 level) clear room was finally accomplished.
In our laboratory, we also built ISO 7 class (10,000) sterile room, microbial limit room, and positive control room.

After almost one year's constructing, our new ISO 8 class (100,000 level) clear room was finally accomplished in Aug., 2016.
There will be total 4500 m2 in new plant. And we developed 1500 m2 in first one initial stage.
In this 1st stage, we also constructed ISO 8 class (100,000 level) clear room with 685 m2
During the whole manufacturing process, we will monitor the bioburden from raw material to components and to final devices to ensure bioburden in stable controlling before Gamma irradiation. 
Finally, our whole team can moved into new manufacturing site in better environment. 
Now, Tianjin Uwell can ensure the whole processes handling in our controlled clean room, mold maintaining, injection molding, handling preparation, assembling, and primary packaging. In new site we can ensure much faster improving speed since we would have a quicker feedback in the whole processes.