Things You May Not Know About Environmental Monitoring of Pharma Clean Room
|10.5.2021||Posted by pharmasources under Advertising & Marketing|
The cleanliness of the air in the pharmaceutical production process is very demanding, and the cleanliness of the air in the production area will directly affect the quality and quality of the finished medicine. Therefore, the FDA and other agencies around the world have stipulated air quality conditions for the production of biological drugs/chemical drugs in pharma clean room.
The first thing you might not know about pharma clean room
Usually people think that this is the cleanliness requirements of dust particles such as dust and debris, but in fact the real danger is the microorganisms on the human body. Humans shed approximately 30,000 skin cells every hour1, all of which are potential carriers of microorganisms. Unfortunately, we currently have no real-time detection technology for microorganisms in the air. Therefore, the air particle counter is used as an alternative.
The second thing you may not know pharma clean room
Air quality monitoring in pharma clean rooms is usually done by quality control personnel. However, a growing trend is that the burden of environmental monitoring is shifting from the quality control microbiology team to the production personnel for two reasons:
- Microbiologists are relatively expensive to perform such routine tasks;
- Reduce the number of people in the pharma clean room, thereby reducing the possibility of product contamination.
However, the production team does not have a high level of understanding of daily environmental monitoring, which poses challenges. For example, increasing the burden of supervisors, transferring responsibilities from quality control to the production team, and possibly thousands of data points per month.
Category:Cleanroom System > Cleanroom
Company:UNIVAL CONSULTANT&ENGINEERING CO.,LTD.
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