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 Clean steam is a controlled utility used where steam quality can affect product quality, product-contact surfaces, sterile processing, or a critical manufacturing environment. This article establishes the intended-use, quality, application, equipment-interface, and regulatory boundaries for clean steam…
Clean steam system design must do more than produce vapor at the required pressure. It must establish and preserve the chemical and physical qualities needed at each GMP point of use while controlling entrainment, condensate accumulation, noncondensable gases, superheat, contamination,…
Clean steam qualification must demonstrate more than acceptable condensate from one convenient sample point. The evidence must show that the installed generator, distribution system, controls, drainage provisions, instruments, sampling arrangements, and equipment interfaces collectively deliver steam suitable for every approved…