Validation of Pure Steam and the verification of the final aqueous rinse in a CIP process are defined by regulatory standards, which change periodically, and challenge system designers and owners to know the latest requirements. This white paper contains an overview of current pharmacopeia requirements, which will assist in the design and monitoring of compliant systems for Pure Steam production and CIP.
This paper also details the requirements for Pure Steam. The second section concerns the requirements for validating the final rinse of a CIP process which may have been performed using Pure Steam, pharmaceutical grade water, or by chemical cleaning. Regardless of the method used, all require an aqueous final rinse and verification.
The USP has established the requirements for Pure Steam, whether used in production or as part of a sterilization or CIP process. On-line and at-line conductivity and TOC measurements provide continuous measurements of steam condensate and hence Pure Steam quality. The verification of CIP final rinse water quality has been a challenge for the pharmaceutical industry and can easily delay equipment being put back in service, resulting in lost production uptime. The regulatory agencies have issued guidelines for CIP processes, and pharmaceutical facilities are challenged to meet these requirements. Using the basic tenet of quality by design, the inclusion of analytical process controls can reduce delays, eliminate sampling errors and lower the cost of cleaning and validating the process.
METTLER TOLEDO Thornton’s portfolio of advanced transmitters, conductivity sensors and fixed and portable TOC sensors offers convenience and high performance for the monitoring and control of all CIP processes.