Dear Experts,
Please guide me with some reference guidelines,
If any AHU in an OSD facility caters more than one area\room and any terminal HEPA of any room is found fail during PAO or any physical damage is observed.
Is it mandatory to re-qualify all other rooms under that particular AHU after changing the damage HEPA ?
it would be better to give some reference guidelines.
Thanks in Advance
Parveen Garg
Dear All Validation Gurus and other members,
As i am new to this forum, and i need your help to resolve my queries regarding present GMP trends and regulatory requirements
But unfortunately nobody has answered my queries…
it will be fine if you told that i have mentioned the wrong queries.
Thanks
parveen.garg@gmail.com
Dear Mr.Praveen,
I think you inquired about HEPA filter integrity test, generally this test name renowned as DOP [Disperal Oil Particulate] test, in earlier days Di Octyl Pthalate is used as dispersant but recently Paly Alfa Olefine is using for conducting of DOP test to check the HEPA filter integrity.
Now coming to your query…
As per my understanding you are using terminal HEPA filters in your process area, genrally during DOP testing in the down stream means in the process area a scanner will be used to check the integrity of terminal HEPA filter. In general during performance qualification of HVAC system the process operations will be terminated.If any failure observed in the respective HEPA that particular filter will be replaced, no need to replace all the HEPA filters in the facility.
Hope you will be clarified.
[quote=parveen.garg]Dear All Validation Gurus and other members,
As i am new to this forum, and i need your help to resolve my queries regarding present GMP trends and regulatory requirements
But unfortunately nobody has answered my queries…
it will be fine if you told that i have mentioned the wrong queries.
Thanks
parveen.garg@gmail.com[/quote]
How would you handle such a deviation. Usually ‘DOP’ test is done on a schedule. We cannot establish when the filter failed.
Jay
This is where we not only qualify that the system works, but are also required to establish an environmental monitoring program. you should be testing the areas on a regular basis and if there are no changes in the EM data, you can justify changing the filter in the same manner that you would with your PM procedures and provide another weeks worth of EM data. If you do not have an EM program, you better get it in place quickly…
Hello Parveen,
I’ll take a crack at the requal aspect.
Easy answer is Yes and more. When you replace the HEPA filter assembly, the HVAC will respond depending on how it was designed. Static systems (usually cheaper to install) are set (velocity/airflow are constant) and left alone with the assumption that they will maintain the complete environment as set. When you replace a HEPA, the response of the system may (or more likely, will) change, hence not only do you need to requalify the room, but the entire system will need to be rebalanced since the resistance will have changed (HEPA are not exact for exact). Since the rooms will change, the cascade effect will change, so rebalancing is needed.
Even for systems with partial (dynamic) control, you would need to rebalance the entire system to ensure it is operating as designed.
Even when a system is completely dynamic (completely automated), you would be best served to ensure it is operating as expected (proper airflow and pressure).
As pointed out with the EM program (expected to demonstrate that you are ensuring the controlled environment), if you are maintaining control spaced (Grade 1, Class 100, ISO 5…or any similar classification), you need to ensure that you are maintaining those conditions.
So when you do replace the HEPA, you need to requalify the area and also address the deviation (that’s another story) and add a CAPA to address the filter failure.
If it was physical damage done by personnel or equipment, then your CAPA may address ways to protect the filters. If was just usage, then you may want to enhance the PM program since you will become painfully aware, that the back trace the use of that area to all manufacturing until the last known good state is going to be no fun. If you do have an EM program, then you are partially saved since you can use your daily/weekly EM data to show that, even with the failure, that there were no harmful effects of the failure to your containment.
You are right Jay, during scheduled testing is there any failure observed, the respective filters will be replaced and the past process will be reviewed.
[quote=Jay]How would you handle such a deviation. Usually ‘DOP’ test is done on a schedule. We cannot establish when the filter failed.
Jay[/quote]
the parameters again has to be checked for all the area it caters
Area classification is based on particle count. It is always advisable to perform a particle count before performing leak testing. Usually, dependent on the size of the leak and the design (recirculation or not), the particle count is within the acceptance criteria for for OSD (grade D). This will provide evident/data for backward evaluation. If the particle count fails, then detail investigation is required.
Jay