白皮書：藥典對 CIP 純蒸汽和最終沖洗驗證的要求

原位清洗（CIP）工藝中純蒸汽的驗證和最終沖洗的驗證由法規定義。由於這些法規會定期變化，系統設計人員和擁有者需要瞭解最新的要求。

本白皮書深入介紹了 Pure Steam 驗證和 CIP 工藝中最終水沖洗驗證的現行法規和建議。

本白皮書概述了藥典要求，這將有助於設計和監測純蒸汽生產和 CIP 系統。

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.

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