Poly Alpha Olefin (PAO) is used for HVAC qualification in pharmaceuticals. PAO is used as a replacement of the DOP (Dioctyl Phthalate) that was used for this purpose for a long time.
Dioctyl Phthalate is found as a carcinogen (cause cancer) for the human. Scientists were trying to find a material to replace the DOP for a long time.
Finally in 2001 Japan Air Cleaning Association (JACA) published a guideline to replace the DOP with PAO. It gives the equal performance to the DOP and doesn’t have any harmful effect on health.
Finally in 2001 Japan Air Cleaning Association (JACA) published a guideline to replace the DOP with PAO. It gives the equal performance to the DOP and doesn’t have any harmful effect on health.
FDA also clearly says that alternative aerosols are also acceptable but they should not promote the microbial growth in the area. Therefore, it is recommended to replace the Dioctyl Phthalate with Poly Alpha Olefin (CAS #68649-12-7). The size of PAO generated aerosol ranges from 0.1 to 1.0 μm.
The PAO aerosols are generated by the aerosol generator and passed through the HEPA filter then the integrity is checked using a photometer. 99.97% particles having a size larger than 0.3 μm should not be passed through HEPA filters.
Poly alpha olefin is a polymer of alpha-olefin. Alpha-olefin is a class of olefins those have a double bond between first and second carbons of the polymer chains.
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| Molecular Structure of Alpha Olefin |
The shelf life of the poly alpha olefin is 10 years in a sealed container but for the opened container it is one year. It should be protected from UV light and direct sunlight.
Is PAO can be used in ULPA filter integrity test where pore size is 0.12 micron in compare to HEPA 0.3micron
ReplyDeleteYes.
ReplyDeleteCan be.
ReplyDeleteSir,
ReplyDeleteYour guidelines are very informative and knowledgeable.
Are your presentations available for training of officers in pharma specially in QC.
Regards
What is downstream and upstream?
ReplyDeleteCan you tell PAO test parameters
ReplyDelete