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
Language:
English
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.

Contributors

  • Paul Lopolito

    Speaker

    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...

Type of Session

  1. Type of Session
    Session

Categories

  1. Track
    Optimizing Facilities through Innovation & Technologies

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