We have found our Terminal HEPA filter integrity was failed during the re validation of HVAC as it was installed one year ago. These are installed at Granulation area and blending area and there is only one AHU is catering the air for both rooms. Our HEPA filter integrity test frequency is every 6 months and following these schedules with out fail. We used to use PAO instead of DOP to check the filter integrity test. Kindly give me an out line / details how to investigate and draw a conclusion on this deviation. What are the points to be considered to evaluate the effect of this problem?
We are going to face ANVISA & MHRA audit soon and shall short out these problems soon. We have done investigation on this issue but i felt it was an inadequate and needs to elaborate it more comprehensively.
We are seeking our forum experts suggestions / assistance and valuable input in this regard.
In my experience with HEPA filters the failure is more often due to the fitting than due to the filter.
The way i would investigate would be as follows:
confirm location of failure ie filter or filter housing
Do you have a prefilter on the HVAC system - if so what levle of filtration does this provide
Is particulate monitoring and micro monitoring carried out in your tabletting area. If so have the results changed significantly during the past 6 months?
How does your air system work - is it a recircualtion system or a first pass system ?
what is your product mix - ie could contamination from one room get into another ?
what is your level of containment over the manufacturing areas ?
was the testing apparatus appropriately calibrated and was the testing carried out by trained personnel?
have you got readings for differentail pressure over the period/
Based on the information you gather, you need to asess the potential risks and the data you have to justify if there has been any change in the environment in the room.
Cathy
[quote=Pulla Reddy]Dear Experts,
We have found our Terminal HEPA filter integrity was failed during the re validation of HVAC as it was installed one year ago. These are installed at Granulation area and blending area and there is only one AHU is catering the air for both rooms. Our HEPA filter integrity test frequency is every 6 months and following these schedules with out fail. We used to use PAO instead of DOP to check the filter integrity test. Kindly give me an out line / details how to investigate and draw a conclusion on this deviation. What are the points to be considered to evaluate the effect of this problem?
We are going to face ANVISA & MHRA audit soon and shall short out these problems soon. We have done investigation on this issue but i felt it was an inadequate and needs to elaborate it more comprehensively.
We are seeking our forum experts suggestions / assistance and valuable input in this regard.