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. P-8.5 is intended to accompany P-8.2, Guideline for Validation of Air Separation Unit and Cargo Tank Filling for Oxygen USP and Nitrogen NF, which contains ASU process validation requirements and the associated industry guidance.
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Edition: 1st Published: 08/09/2006 Number of Pages: 21