I have one questions regarding HVAC validation, we are in PQ phase of HVAC validation and completed all necessory tests such as airchange rate, non-viable particle counts, HEPA integrity test etc for ISO 8 facility which is a solid dose manufacturing unit. Can anyone tell be for how much period the monitoring of temperature, humidity , pressure differential and microbial plate exposure(viable particle count) has to be done before we release the area for normal production? Anyone has the reference to ISO14644, does it mention any time period? Normal trend in industry is 1 week to 28 days? But in my opinion 28 days is too long. Please advise.
We started it with DQ which included URS covering all aspects and parameters of room conditions such as particle count, air change rate, temperature and RH requirements. As far as ISO class is concerned we designed it for ISO 8. Now all AHU units are running prfectly, OQ for each AHU is done separately and we are in process of initiating PQ under common protocol for entire area.
Hope i was able to clarify,
Too late to give the reply, but with hope for new/ future readers.
Time period for routine Diff Pressure / Temp. / RH monotoring is decided based on the statastical evaluation of these values with inclusion of whole day variations along with magnitude of variance %.
In opinion 8 days with reading at 2 Hrs interval is sufficent to evaluate & challenge the sytem.
Don’t forget the crisis one “Simulation with operation in rest condition” ensure sweeping time & restore times are well evaluated before running full swing operation…
One week should be fine, if all results are within acceptance criteria, of course.
After that, you can release the facility for production, but I strongly recommend that you have a year long follow up (PQ 2 you can call it if you wish) to ensure any seasonal variations are well managed and doesn’t affect your room conditions adversely. This is common practice as well, since most countries have a strong seasonal weather variation which can stress your system in different ways (humidity, temperature etc).
This will also give you ample data to use to trim down the frequency of your environmental monitoring system after the full year.
Can you plaese tell me about the neutralizer added to the media used for environment monitoring of Ceplasporin facility and what should be the quantity/concentration of that to the media.
Following points needs to be covered in PQ of HVAC Systems
1.Non-Viable and Viable particle counts.
2.Air Flow pattern Test.
3.Air Velocity and Air changes test.
4.Temperature and %Rh Measurment
5.Pressure Diffferential Monitoring (minimum wvery after 02 hours for three days in any shift G I or II).
Dear friend,
we incubate SDA plates for 5-7 days as per harmonized method.is it 5 days or 7 days or any day 5th ot 6th or 7th? what is the rationale?
regards,
varma