What is the frequency of periodic Qualification of HVAC system of Solid dosage pharmaceutical products.
Particle count test all class- 6 month
Diff. press, velocity, air changes all class- 12 month
as per WHO Guideline
Just an update, the WHO guide WHO_TRS_961, Annex 5, Supplementary guidelines on GP for heating, ventilation and air conditioning systems now states that the recommended intervals between the required testing should be determined through risk assessment and not as per the previous guide that stipulated specific intervals.
Hope this is of some help to you as it was to me.
This is ref to Mr.Ravi asalkar wrote
The whole ISO 14644 1 to 10 guidance is going to change or Revised by August 2013.
The Working group on these document of classifications of air and particulate matter met in Copenhagen in the month of March 2012.
The whole guidance now is based on
-Air borne particles
-Particulates gnerated by various sources
-Surface used
-Chemicals used
The whole frequencies of monitoring is going to changed based on GMP guides.
When this document was earlier made it was not industry specific. They made for many industries clubbed together.
This will change monitoring methods, Frequencies, Calibartion of monitoring equipments and measurements too.
Regards