WHO Guideline-Confusion

Dear All,

In WHO guideline ( point 7.2.3 ) ,it has been given that HEPA filter is not necessary to be installed in single product facility. But if we are claiming that room is Class D , how can we achive this cleanliness for 0.5 amd 5 mic by only installing fine and pre filter.

Vinod Kumbhar

Its about risk of contamination. In single product facility it cannot happen. The above words does not mean that you need not have a HEPA even in Aseptic manufacturing or other areas.You must have required air filtration/handling units in your facility as per GMP.
Its about number of HEPA’s you must have.