Compressed gases like nitrogen, argon, carbon dioxide, and oxygen are essential in cleanroom environments across pharmaceutical, biotech, and semiconductor industries. These gases support critical processes such as inerting, purging, packaging, and cell culture maintenance. However, improper monitoring can introduce contaminants, compromise product integrity, and lead to costly regulatory violations.
USP Chapters <797>, <800>, and <1207> provide critical guidance for compressed gas monitoring in cleanrooms, ensuring gas quality, system integrity, and compliance with Good Manufacturing Practices (GMP). This blog breaks down these standards, explores key risks, and outlines best practices for maintaining cleanroom compressed gas compliance and audit-readiness.
Cleanrooms rely on high-purity gases to maintain sterile and controlled environments. Common gases-nitrogen, argon, CO₂, and oxygen-each have unique properties and play vital roles in cleanroom processes, including inerting, purging, packaging, and, in some cases, supporting sterilisation. Below is a summary of their applications:
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