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.
in non viable particles only why we are using 0.5micron and 5.0micro
ReplyDeleteParticles measurement is very important inclassified area. Different guidelines like ISO, EU GMP has defined certain limits for these particles for a particular class in classified area. Particle counters are used for monitoring of non viable particles. If number of these particles increases in particular area then they may cause product contamination, so control over particles in classified area is very important. But why all guidelines talk about 0.5 and 5.0 micron particles. Why these particles particles are so important to measure and what about the particles smaller than 0.5 micron and particles greater than 5.0 micron, aren't they important?In classified area non viable particles are generated in the environment through system, process and movement but how viable particles are generated in the classified area? Personnels are the main source of viable particle contamination.Viable particles are carried by the personnels working inside the classified area. Millions of bacteria are shed by the body of personnels on continous basis. But how microbes move in classified area, are they freely movable or require any source for movement? Microbes can't move on its own, first they require a source for attachment and this source is particle. Non viable particles are main source for movement of viable particles because microbes first attach to the non viable particles and after attachingto these particles they are carried from onearea to another area through air movement. 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 lesslikely to attach to this size of particles and greater than 5.0 micron particles become heavy as size of thesek 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 partilces aremeasured in pharmaceuticals.
DeleteIt's absolute true!
DeleteWhat should taking into consideration if the non viable particles out of limit? Is it allowed to release the batch if the microbial test within the limets?
ReplyDeleteWhat should taking into consideration if the non viable particles out of limit? Is it allowed to release the batch if the microbial test within the limets?
ReplyDeleteYes based on the environment monitoring you can confirmd viable particles in surrounding environment and if those are within defined limit then there will be no affect on your release product, you u can release your product but you should do investigation for failing of non viable particl count and take capa.
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