Compressed Gas Systems In Aseptic Manufacturing

In aseptic pharmaceutical manufacturing, the reliability and safety of utility systems are of utmost importance. Utilities are generally divided into two categories: process systems and process support systems. While process support systems do not directly affect product quality or patient safety, process systems are crucial as they come into contact with products or key materials. Among these, compressed gas systems are particularly important.

Compressed gas systems, such as those using air, nitrogen, carbon dioxide, or gaseous hydrogen, are integral to various stages of the aseptic manufacturing process in pharma. Therefore, effectively identifying and managing the risks associated with these systems is critical for maintaining product quality and ensuring compliance with Good Manufacturing Practices (GMP).