Biomedical Purification Changing Room Design

In the latest clean room GMP standard, clear provisions are made for the setting of clean dressing areas. Therefore, when designing clean room, multiple key factors must be considered comprehensively: ​

1. Layout planning of dressing rooms ​

Separate the dressing process according to different stages through independent rooms. Specifically, it can be divided into multiple functional rooms such as changing shoes , wearing clean clothes, and air locks. Among them, the last air lock room shoulders the important responsibility of isolating the airflow between the dressing area and the production area. ​

2. Hierarchical management of dressing areas ​

The new version of GMP clearly requires that wearing of clean clothes and the subsequent air lock area, and their clean level must be the same as the level of the production area they serve. The front section of the dressing area, as an auxiliary area for clean dressing, does not participate in classification, but needs to be supplied with air filtered by HEPA filters and ensure a certain number of ventilation times and pressure gradients. FDA calls it CNC (Controlled Not Classified). ​

3. Control of the pressure difference in the dressing area ​

The dressing area is the only way for personnel to enter and exit the clean production area. The pressure difference follows the principle of flowing from the high clean level area to the low clean level area. It is recommended to maintain a pressure difference of 5Pa between adjacent airlock rooms. Through such a setting, it can ensure that the pressure difference between the clean area and the non-clean area is within a reasonable range, and the pressure difference will not be too large, causing a large amount of air leakage through the door gap, or placing too high requirements on the strength of the building partition.

4. Monitoring of the pressure difference in the dressing area ​

Since the clean level of the back section of the dressing area (wearing clean clothes + airlock) is consistent with that of the production area, the pressure difference between these two areas must be monitored. The differential pressure gauge needs to be set between these two rooms and other areas. At the same time, according to the standard that the pressure difference between the clean area and the non-clean area is greater than 10Pa, the pressure difference between this area and the front section of the dressing area should also be greater than 10Pa. ​

V. Setting of exit channel​

Sterile drugs can be equipped with separate dressing rooms for entering and exiting the clean area. For highly sensitizing, highly active, and highly toxic drugs, in order to limit the leakage of air in the production area exposed to the drugs, it is necessary to set up an exit channel in the dressing area and equip it with a negative pressure water blocker to effectively block the airflow in the production area.