Particle Counter in Pharma Industry
A particle counter is a device designed to measure, monitor, and diagnose particles of any substance in a given volume of media like air, water, or other chemicals. They are also used to detect particle contamination in clean media or on surfaces present within controlled environments.
During particle count, we measure only 0.5 and 5.0-micron particles because most of the commonly found bacteria are in the size range of 0.5 to 5.0 micron so this size range is the main source of contamination in cleanroom
There are many variables needed to reach a specific clean room cleanliness certification, but a particle counter is an essential tool used to monitor, classify and diagnose the source of contaminants in clean room operations.
HEPA air filtration systems and insulated walls are just two design component options to block contaminants. Airflow also provides a crucial role in maintaining a contamination-free modular cleanroom.
Why is 0.5 and 5 micron particle count required in pharma?
During non viable particle monitoring 0.5 and 5.0 micron particles are measured because most commonly found bacteria range is in between 0.5 to 5.0 micron so this range of particles are the main source of product contamination and can be carried from one area to another area very easily with the air movement. Size less than 0.5 micron is not very critical because microbes are less likely .to attach to this size of particles and greater than 5.0 micron particles become heavy as size of these particles increases and can be easily settled down as compared to 0.5 and 5.0 micron particles. That’s why 0.5 and 5.0 micron particles are measured in pharmaceuticals.
Read also:
- HEPA Filter in Pharmaceutical Industry
- Potential Risk of Particulate Matter in Pharmaceutical Manufacturing
Resource Person: Ch/Ahmed Mahmoud
