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.

Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Included in this control, the monitoring of microbial contamination is essential in the pharmaceutical, cosmetic, and food and beverage industries. Physical and microbial monitoring of manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators should include several components (download full paper for details).

A large proportion of products labeled as sterile are manufactured by aseptic processing rather than terminal sterilization. Aseptic processing relies on the exclusion of microorganisms from the process stream and the prevention of microorganisms from entering open containers during processing, so product bioburden as well as the bioburden of the manufacturing environment are important factors governing the risk of unacceptable microbial contamination. The terms aseptic and sterile are not synonymous. “Sterile” is a medieval word derived from the Latin sterilis (unfruitful), meaning, in modern terms, free from living germs or viable microorganisms that have the potential to reproduce. In contemporary aseptic healthcare product manufacturing, "aseptic" describes the process for handling sterilized materials in a controlled environment designed to maintain microbial contamination at levels known to present minimal risk.

Topics discussed in this paper:

  • Quality attributes of manufactured pharma products
  • Pharmaceutical environmental monitoring
  • Compressed gases in regulation and pratical applications