(192d) Clean Steam System Design, Start-up, and Qualification

This presentation will provide the audience with information about design, start-up, and qualification of Clean Steam systems including applicable regulations to ensure that a system is started up efficiently and in a state of compliance with cGMPs.

Design

Clean steam systems present some unique challenges that are best solved during the design phase. Establishing appropriate user requirements at the project inception and designing the system accordingly can help the user avoid significant delays during start-up and qualification due to re-design work. Chief among these requirements are whether or not the facility must comply with EN285, outdoor venting of the steam during start-up, sample point locations, passivation strategy, and proper elastomer selection.

Start-up

During start-up of the system, it is important to understand the state of surrounding systems and whether or not they are ready to receive steam. If they are not, the surrounding systems must be locked out and an alternative outlet for the steam should be available so that clean steam generator start-up and load testing can be completed without additional delays. Venting of the clean steam header during shutdowns is also important to avoid vacuum formation and the potential for backflow from condensate systems.

Qualification

The user may also encounter significant issues during qualification of the system. During the Installation Qualification phase, special attention should be paid to weld quality and piping specification compliance. Operational qualification should focus on delivery of appropriate quantities of steam to the end users. Performance Qualification/Validation should ensure that the steam quality meets the appropriate standards, including both condensate samples for laboratory analysis and field sampling for EN285 compliance.