Pharmacopeia Requirements for Pure Steam and Final Rinse Verification of CIP
The validation of Pure Steam and the verification of the final rinse in a Clean-in-Place (CIP) process are defined by regulations. As these regulations change periodically, system designers and owners need to know the latest requirements.
This white paper provides an insight into the current regulations and recommendations for the validation of Pure Steam and the verification of the final aqueous rinse in a CIP process.
The paper contains an overview of pharmacopeia requirements, which will help in the design and monitoring of systems for Pure Steam production and CIP.
The first part of the paper looks at the requirements for Pure Steam. The second part concerns the requirements for validating the final rinse of a clean-in-place process in which Pure Steam, pharmaceutical grade water, or chemical cleaning has been used.
Regardless of the method, all require an aqueous final rinse and verification. Verifying the final rinse confirms that the previous steps in the process have achieved the desired goals and allows equipment to be returned to service.
Continuous monitoring of total organic carbon (TOC) and conductivity provides the necessary information for confirming Pure Steam quality and CIP final rinse verification.