Compressed Air System Validation

[SAK9]

Guys,

I am supplying o.3 micron filtered air into the Production Suites of a pharmaceutical manufacturing facility.The air comes in contact with the product.Is it necessary to validate the compressed air generation system or is it sufficient to validate the system down stream of the fine filters?

Thanks for your help

 

[MedicineEng]

I would say that you still need IQ/OQ for the air compressor(s) and a way to assure the integrity of the filters downstream. Also you have to assure that your filter is sufficient to retain all particles and contaminants (oils, moisture, etc.)

 

[quark]

As far as process validation is concerned, microbial evaluation of compressed air is sufficient. However, like MedicineEng suggested, equipment qualification is an inherent practice. Include moisture content and oil traces (visible inspection method by blotting paper is ok if you are using non lube compressors)

 

[enr]

I think , you have to use 0.01micron filter if the air comes to direct contact with product like jetmill.Preferably u can use the ss316 pipe after this filter.