On-Demand Webinar

Sterile Filtration Validation Best Practices

Duration: 1 Hour
Speaker: Ross Acucena, Regulatory Consultant, Services and Solutions, Merck

Abstract: Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed. However, specific guidelines regarding the length of time a filter can be used or the number of batches a filter can produce are not well defined. This webinar will provide recommendations for a well designed approach to validating filter use for multiple batches or extended processing time. Join us as we elucidate these guidelines and recommend a practical approach to validation which balances processes efficiency and risk.

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