This category focuses on clean steam systems used in GMP applications requiring controlled steam quality. It addresses system design, quality attributes, qualification strategy, routine monitoring, and requalification to ensure clean steam consistently meets defined purity and performance expectations.
Purpose and Scope This article defines the qualification strategy, ongoing monitoring expectations, and requalification approach for clean steam systems used in GMP applications. The focus is on establishing and maintaining documented evidence of control over the clean steam system throughout…
Purpose and Scope This article defines the design principles and quality attributes required to ensure a clean steam system is suitable for GMP applications throughout its lifecycle. The focus is on engineering intent and inherent system capability, not on qualification…
Purpose and Scope Clean steam systems are GMP utilities intended for direct contact applications where steam or its condensate may contact product, product-contact surfaces, or critical process equipment. This article defines where clean steam is required, why it is required,…