ISO5 clean rooms, also known as class 100 clean rooms, allow only 100 particles (100,000 particles/m3) of size of 0.5 μm or greater per cubic foot of air. This classification is at the more critical end of the spectrum and requires a high level of filtering.

In order to minimize particulate contamination in ISO 5 cleanrooms, the use of clean room suits with no shedding of polyester is only allowed. They are usually made of Gortex, Tyvek, Dacron or other non-woven materials. And the entrance of the changing room needs a sticky mat, in order to remove particles before entering, after stepping on the sticky mat and entering the changing room, to prepare shoes cover. A HEPA-containing filtration system is required in the wardrobe to remove unwanted particles. Use easy-to-clean robes and benches to wear overalls. After each use, please prepare sterile wipes to clean the workbench.

In the main work area, the clean room ceiling should be full covered with FFU units to control cleanliness, and on the head of FFU units connected the air duct also control temperature and humidity. Of course, we also recommend that guests use part of the ISO 5 room design in the necessary production process, other areas according to the production requirements of ISO 6 or ISO 7, this is a relatively cost-effective way to get local FAD approval.

                 

                 

Suzhou Pharma Machinery Co.,Ltd.

2023/03/31

Lucy