Main Puropse of Particle Monitoring?

[newsc]

Dear all,

There is a particle monitoring program in my company. Currently, a debate is on about under which circumstances, the execution of particle monitoring is proper. Current practice is to conduct the particle monitoring only after a thorough clean of the room. But question has been asked if we can do the test after a within-campaign clean, where power in the room might be visible.

I would like to get your advices on the main purpose particle monitoring serves (in general)… is it to verify the purity of air supplied to the room, the air flow in the room (the ability of pushing the particles to move in a certain direction) or both? Or there are other purposes?

Thanks in advance for you advices!

 

[quark]

If your facility is newly built then you should, first, thoroughly clean it before attempting particle counting. Some companies even use fogging procedures to settle initial particulate load. Once you start daily activity then you should check the paritcle count in operation condition.

By particle counting you are ensuring that your product is not being contaminated and particles generated in the area (by people, machinery and building fabric etc.) are swept away by the circulating air.

Different tests are performed to check air flow pattern. It is redundant to check the quality of incoming air if you use proper filtration. Nevertheless, incoming air quality is better comparitively.

Regards,

 

[MedicineEng]

Quark:
The in operation mode is only applicable to some types of processes. See for example that you have a tabletting machine say in a class ISO8. For shure if you are working, most probably your monitoring will fail since the particles generated are mainly from the product itself and not contaminants. What can be done is a simulation of operation without the powder. Or classify your room in at rest condition.

PR

 

[newsc]

Quark and Paulo,

Many thanks for the advices! One follow up question: if we want to do a simulation of operation w/o powder after we start the daily activites, shall it be done as sort of "qualification" or as a routine monitoring program?

Paulo; I am not sure what you meant by "classify the room in at-rest condition". Can we still classify so if we have already started the daily operations in that room?

Thanks!

 

[MedicineEng]

newsc:
The question of the classification or daily monitoring is depending on the product that you want to protect. For instance, if it is a injectable grade product, you might want to have a in-line particle counting monitoring due to the sensibility of the product. If it is a solids dosage form, you might establish a schedule of monitoring, like for instance once a month or once every three months.
The in-rest situation is when you have your room empty and the machines turned off.
One suggestion that I give you is if you are going to start the program (again depending on the product that you are making and how stable your sytem is), start it with an
extended periodicity (meaning for instance 3 months instead of 1 or something like that) because if you start with a very short periodicity you will have a lot of extra work and when you want to increase the periodicity you will have the compliance department asking questions and justifications and you will pass a living hell to convince them that increasing the periodicity of monitoring will not affect the quality of the product.

PR