Particle Count Monitoring

Dear Friends,

Our facility does not comply as per GMP requirements (15 years old). In controlled area particle count(PC) is monitored daily (reason unknown), but as per ISO, PC is monitored either 06 or 12 months once.Sometime the count in certain location cross the action limit.

  1. In this case whether it will be addressed as Incidence or OOS (When does
    not complies the limit).
  2. Since facility does not comply to GMP requirement is it mandatory to
    record PC on daily basis?
    Can any one suggest the possible corrective action which can be addressed for this issue.


Hi, first i recommend that you test HEPA filter integrity, so would you please highlight what is the class of clean room you talking about.


We have a report for installed HEPA filter integrity test (yearly once testing) wich states that the filter is fully scanned & passing the acceptance criteria i.e ( <0.03%) as per the report.
Our Controlled area classification is class 10,000