Pass box qualification

Validation
7

Dear All,

  1. As per ISO 14644-3 : Recovery test is not recommended for unidirectional air flow installation, then why usually pharma companies conducting for Dynamic pass box?

  2. What should be the differential pressure for the dynamic pass box with surrounding environment and which grade to be considered with respect to?

  3. What will be the class of Dynamic pass box which will be installed between C and B area?

  4. Suppose Efficiency of pass box is conducted in static mode earlier shall it required to be conducted in dynamic condition- in actual installed area?

Thanks

1 Like