Compressed Gas Risk Assessment - A Significant Piece of a CCS

Introduction
Utilities can be classified as process systems or process support systems based on their use. Utilities that do not affect product quality or patient safety in any way are normally called process support systems (e.g., HVAC). All utilities in direct or indirect contact with the product or with critical materials as well as utilities in contact with components such as piping, valves, or pumps are considered process systems and are critical because they can potentially impact the quality or effectiveness of the final product in a significant way.
The utility of compressed gas is a process system. Compressed gas is an integral part of many processes and can be used in many phases of a process. Compressed gas systems include, for instance:

• air
• nitrogen
• carbon dioxide
• gaseous hydrogen

The design and use of compressed gas process systems must be documented, and the criticality of the system must be determined in a GMP environment (e.g. via a risk-based approach). As stated in Annex 1 in the section on utilities, compressed gases and other utility systems should be properly designed, qualified, maintained, and monitored to prevent contaminants from affecting product quality, stability, and/or efficacy.