Compressed Gases: An Important Component of an Environmental Monitoring Program in a Pharmaceutical Manufacturing Environment

Compressed Gases: A Brief Regulatory Overview

The testing and monitoring of compressed air and other process gases such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products. Compressed air is a Critical Process Parameter (CPP) whose variability has an impact on the Critical Quality Attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.