CGA TR-3

This publication describes how potential contaminants in the air separation process are eliminated or minimized to low level concentrations that pose no hazard or risk in medical oxygen USP or nitrogen NF.

As a prerequisite step to conducting a full risk assessment of the air separation process, CGA conducted a study of contaminants that can be found in ambient air and the impact of the air separation process on these contaminants. Developing an in-depth understanding of possible sources of ambient air contamination and the role of the air separation unit (ASU) in controlling and eliminating these contaminants significantly increases the accuracy of the conclusions developed during the risk assessment process.

This publication is intended to accompany CGA P-8.2, Guideline for Validation of Air Separation Unit and Cargo Transport Unit Filling for Medical Oxygen and Medical Nitrogen, which contains ASU process validation requirements and the associated industry guidance.

This publication evaluates possible sources of ambient air contamination and the role of the ASU in controlling and eliminating these contaminants.

The ASU contaminant evaluation includes:

• identifying potential contaminants;
• physical and chemical properties of the contaminants;
• ASU impact on contaminants;
• oxygen concentration factors;
• concentration levels of contaminants remaining in oxygen;
• particulates; and
• conclusions/data evaluation by a third-party toxicologist and by industry.