PURE STEAM VALIDATION INSTRUMENTS
Pure steam is often used in applications such as sterilization not only to remove contaminants, but also to ensure the quality control of critical attributes such as dryness, superheat and production of non-condensable gases, all of which could adversely affect the process and equipment. In unit operations, either the equipment or the pharmaceutical product may be exposed to steam or its condensate. Where this could affect product quality, strict practices needs to be in place in the form of Good Manufacturing Practices as enforced and regulated by the US FDA and the European EMEA. As with clean steam, pure steam is created within a dedicated generator, but one designed, built and operated in accordance with GMP requirements. The purity of the steam produced is such that its condensate matches the regulatory specifications governing Water for Injection.