Frequently Asked Questions

There is Class A air supply in Class C area, which is the concept of local protection. Class A air supply has the requirement of stationary particle test, but no microbial control limit standard. It is up to the enterprise to decide whether to sterilize the clothes or not. Companies recognize in practice that too much sterilization or disinfection with ozoneIf disinfected with ozone, cleanroom clothes are easy to lose chips/fibers, which is not good for the environment.If disinfected with ozone, clean work clothes are easy to lose chips/fibers, which is not good for the environment. If the microbial count exceeds the microbial limit for the corresponding level of surface, you should take into account the improvement of the cleaning procedure and consider disinfection or sterilization only if necessary. In short, it is based on data and handled according to the amount of risk.

GMP Class A and B have to be cleaned every time it comes out, then it is sterilized in breathing bags, and Class C clean clothes are sterilized once a week.

PDA TR61 clearly states that the control strategy for SPF processes using time and temperature as process parameters can also be used to calculate Fo values as process parameters. The use of time and temperature for control relies on experience gained during process development and is usually dependent on the successful, uninterrupted sterilization of the system at a relatively constant temperature.
When the temperature (monitored at critical locations throughout the system) falls below the specified minimum process temperature, the timer should be stopped or retimed. When making the A Fo value control, the end point of an SP process can be determined based on calculating the equivalent physical killing capacity at different temperatures.) So, it depends on your determination criteria, if the temperature and time as the determination criteria, must be re-timed; if the FO as the determination criteria, can be unnecessary

If there is no double-capacity sterilization cabinet and you have to transfer through the aisle, it is recommended to use sealable crates or breathing bags and disinfect well at the same time. After sterilization, put the clothes into a sealed crate or breathing bag, and wrap a plastic bag or plastic film outside as the outer packaging.
Come out from the transfer window or logistics channel, pass through the general area and enter the material buffer room of another clean area.
Remove the outer packaging, wipe the surface of the crate with alcohol spray for disinfection, leave the people for 15 minutes for self-cleaning, enter the clean area to take away the crate and take out the sterilized clean clothes and place them in the clean clothes storage point in the workshop.

Cleanroom sterile clothes are generally smooth, because this way it will not be easy to get static electricity. And there is no hair that will fall off, because if something falls off and there is static electricity around it, it will stick to the top of the clothes, thus creating friction and static electricity.