EXPERT – CLEAN ROOM
Environmental excursion investigations are complex and multidisciplinary and require the investigator to elicit information from multiple departments to aid in determining the true root cause.
Excursions investigations are aided by a robust environmental trending program that should evaluate data for individual sites, rooms, suites and the normal microbial flora of the facility.
Proper investigation encompasses manufacturing areas, classified areas and microbial testing laboratories.
Failure to properly investigate environmental excursion to true root cause will not allow for appropriate and effective corrective actions.
This leads to lack of environmental control of you manufacturing or laboratory operations.
Ultimately,this may lead to product failures and possible regulatory actions or worse patient interactions.