Validation of Nitrogen Systems in Sterile & Non-Sterile Pharma Applications Validation of Nitrogen Systems in Sterile & Non-Sterile Pharma Applications Nitrogen (N₂) is extensively used in pharmaceutical manufacturing for purging, blanketing, conveying powders, and maintaining an inert environment during sensitive processes. As a utility that may come in direct or indirect contact with pharmaceutical products and packaging, its validation is crucial to ensure it meets the necessary purity and sterility standards as required by global regulations. This article provides a comprehensive, step-by-step protocol for validating nitrogen systems in both sterile and non-sterile pharmaceutical environments, based on GMP, USP, FDA, EMA,…