Rethinking Cleaning Validation for API Manufacturing

Rethinking Cleaning Validation for API Manufacturing

04/03/2019, 1:15 PM - 2:00 PM

Javits Conventions Center - Stage 4, Booth 2276, Exhibit Hall
Cleaning validation is a regulatory requirement around the world and an integral step within the manufacturing of active pharmaceutical ingredients (APIs). The goal of a successful cleaning validation program is that cleaning procedures are defined, analytical methods are qualified, and acceptance criteria are continuously met. A laboratory cleaning evaluation was performed on fifteen generic APIs. The cleaning performance results combined with solubility and toxicity information were used to select three active pharmaceutical ingredients. Fourier-Transform Spectroscopy (FTIR) direct surface sampling technique combined with visual inspection were used to ensure the product contact surface were clean. Designing a risk-based cleaning process correlating direct surface sampling, visual inspection and coverage testing to in-line rinse solution enables an efficient, low cost means to continuously monitor the API equipment cleaning procedure.


  • Paul Lopolito


    Technical Services Senior Manager

    STERIS Corporation

    Paul Lopolito is a senior technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides...

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    Optimizing Facilities through Innovation & Technologies

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