can any body tell me
what is the volume to be sucked during the HVAC qualification FOR GRADE B AND GRADE C AREA ,.
IS THERA ANY GUIDELINES SPECIFY THE VOLUME TO BE SUCKED DURING PARTICLE COUNT OF GRADE B and GRADE C area
If you are asking about Active Air sampling requirement : Then the volume of air sampled from the instrument must be :
[COLOR=“blue”]Not less than 1000 liters of Air/ 10 minits.
Or not less than 100 liters of air/minit.[/color]
ISO/DIS 14698-1 : It is not less than 100 L/min with an impaction speed <20m/second, capturing particles of size 3 to 10 microns.
Is there it is mendatory to take 1000L of air sample for particle count for routine periodic qualification as performed initial qualification of HVAC.
There is no difference in Sampling Methodology for Initial Qualification & Re-qualification. In my opinion, the query is for Time saving during re-qualification…due to reduced sampling volume…is it ?? You may refer the requirement document published by USFDA but they spelled it for Grade-A area. I am not pretty sure about what product you are manufacturing or activities being carried out in that area. Industry practice for Non-critical area is Sampling Time 1 Min with Min. sample Volume 1 CFM. (ISO 14644)
Friends…Opinion Please,
In current world what is happening, Validation & qualification activities are more sounded like Implication or forced by law only…we are finding ways & means to avoid that, eliminate that…skip that. No body even in this forum of professionals is discussing about Impact / benefits of Validation & qualification & why we should not adopt. We respect the manufacturing operation & Time cycles as well…but why the biased approach adopted for Validation / Qualification activities ?
No doubt one can take benefit of assessment & reduce the excess activities…but approach should be positive.
Happy Reading !
Hi, can somebody tell me should i check the productivity of central conditioner? For example if in specification says that it’s about 9000 m3/h, and when we checked the flow rate on hepa filter it were summary about 12000 m3/h.
So how should i check the flow rate of conditioner and what the result would say to me.