Frequency of particle count test

GOOD VALIDATION PRACTICE (cGVP)
1

I have a query regarding particle count test (HVAC Re-qualification).

According to WHO Geneva-trs 937, maximum time interval for particle count test for all classes is 6 months but in ISO 14644 -1, annex-B i.e. for class ≤ ISO 5, time interval is 6 months & for class > ISO 5 max. time interval is 12 months.

Please suggest me what is the frequency of particle count test for class 100000 (non sterile processing) area.

Haresh

2

for 100K (ISO8) is 12 months, at rest only…do you have ISO-14644?? Send me mail address to PM!!!

vbr, a

cubica:)

3

Hi all. Although the ISO states that for class ≤ ISO 5, time interval is 6 months & for class > ISO 5 max. time interval is 12 months, the WHO 937would then overide your ISO requirements for > ISO 5 as it is the most “stringent”.
It seems the best step to take would be to stick to the 6 monthly as per WHO 937 and then review the 6 monthly schedule after 2 years using the data from all the particle counts, maintanance and calibration, Filter management, change controls etc, do risk assessment and explain away the 6monthly tests.

Hope this is of help.