dear members
i have had experience of testing the integrity of HEPA without the temperature in place in a tunnel. but my client ask me y cant we test during hot air of 300 degree in place ,is it possible any guideline says anything on this…
[quote=dominicbenny]dear members
i have had experience of testing the integrity of HEPA without the temperature in place in a tunnel. but my client ask me y cant we test during hot air of 300 degree in place ,is it possible any guideline says anything on this…[/quote]
I don’t practice at this temperature but i think it’s possible with particular counter method and cooling system.
I use this method with DEHS in cold conditions but I don’t know the reaction of DEHS at this temperature.
I practice particular counting at this température with a cooling serpentine.
There is a company in Germany that can build a system that will cool down the air and be suitable for a particle counter.
As I remember - it was expensive, and it had special devices that compensated for air condensate during the cooling phase.
I have never seen any GMP guide that requires testing at operational temperatures.
If I may ask: Are you speaking about DOP filter testing or particle counts?
Do you significant problems with DOP oil contaminating the tunnel during tests?
Some oven and tunnel suppliers suggest that only particle counts be done, as DOP testing is not suitable for these devices - however, the Auditors don’t care about the supplier’s recommendations - it can cause headaches!
hi i waa talking about DOP/PAO.
Hi, we did the DOP test on a cartridge dry sterilization tunnel of a manufacturing line few months ago, but at room temperatures.
I never heard to execute a DOP at high Temperature.
You have first to heat the HEPA filters after the installation/ replacement before use above the maximum process temperature (normally around 350 °C) in order to prepare them and avoid future breakages.
Then you perform the DOP test but at room temperature.
Hope this help.
Cheers