Doc. 219/19Guideline for Validation of Air Separation Unit and Cargo Transport Unit Filling for Medical Oxygen and Medical Nitrogen

This publication provides the EIGA position and guidance on the manufacturing, bulk product storage, and cargo transport unit (cryogenic tankers and containers) filling validation activities that take place at a typical air separation unit (ASU) that is manufacturing medical oxygen, medical nitrogen, or both. Variations from the typical ASU process configurations can exist. Companies shall assess variations and determine if deviations from this guidance are necessary.

The approach and activities in this publication are designed to ensure that these gases, which are classified as drug products, have the claimed identity, strength, quality, and purity.

This publication addresses validation for ASU cryogenic manufacturing and cargo transport unit filling processes relating to medical oxygen and medical nitrogen meeting the requirements of the European monographs.

The publication is part of the programme to develop Globally Harmonised publications amongst Regional Gas Associations.