Knowledge Category: Regulatory

Regulatory Compliance with Pharmaceutical Viable Air Monitoring in ISO 5 (Grade A)

Viable air monitoring is a crucial part of an environmental monitoring program in pharmaceutical manufacturing. The absence of microbial contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. It has been many years since common viable air monitoring methodologies have been introduced and become standard. It is well documented that traditional methods are insensitive. Singular results only provide an indicator of cleanroom status, and very often no direct correlation between number of organisms and product contamination risks are found.