In pharmaceutical companies monitoring of controlled area is performed by two methods.
- Viable particle monitoring
- Non- viable particle monitoring
In pharmaceutical companies drugs are manufactured in controlled or aseptic areas. So before going to manufacture any product we need to verify the manufacturing environment by monitoring viable and non viable particles.
Viable particle monitoring: Viable particles includes bacteria, fungus and their spores and to check the number of these particles we have an environmental monitoring programme which includes Settle plate exposure (Passive air sampling), Active air sampling, Surface monitoring and Personnel monitoring methods. So monitoring of environment by these methods is called viable particle monitoring. By using these different methods we can determine the number of cfu's in particular class of area. Pharmacopoeias and regulatory agencies have defined certain limits of viable particles in these controlled area and number of colony forming units (cfu's) should be less than the final defined limits. If microbes are not with in the limits in the manufacturing area then they may cause product contamination. By using these methods and based on the observations we can assure that the number of cfu's are with in the limits and controlled area is safe for drug manufacturing.
Non-viable particle monitoring: In non-viable particle monitoring we check the number of particles of 0.5 and 5.0 micron size. These particles also should be with in the limits. Particular counter is used for the non viable particle monitoring but there is a limitation of this instrument. This instrument can't differentiate between viable and non viable particle. Any particle either viable or non viable if detected by the sensor of this instrument, it will count this particle. If non viable particles increases in a particular area then there will be chance of increase in the viable particle count also because viable particles are not free floating they need a carrier to float from one area to another area. So these viable particles are carried by the non viable particles from one place to another place.
So, to control a classified area we need to control both viable and non viable particles.