Due to the potential risks of using filtration as a method of sterilization, many regulatory agencies are requiring the use of redundant filtration for final product sterilization. Regulatory requirements for redundant filtration have become more stringent in the past decade and can vary significantly by geographic region. This creates a moving target for regulatory compliance for new and existing products being sold or manufactured in new markets. Long processing times, high product value, and the risk of reprocessing in case of filter integrity test failure during final fill operations are also practical drivers for the adoption of redundant filtration. The operational complexity of using sterile filters in series can make the implementation of this process difficult. For this study, the strategy and execution of post-sterilization integrity testing of filters, before and after use, are examined for regulatory compliance and minimization of risk to the process. Other key implementation aspects such as filtration train sizing and flushing requirements for extractables and leachables are reviewed. Regulatory compliance requirements from different regions were reviewed, and their implications for system design and process sequence are evaluated. Finally, the ability and potential benefits of single-use assemblies to meet the operational and regulatory demands of redundant filtration are considered.

Implementation of redundant sterile filtration process for bulk and final fill operations

243rd National Meeting (2012)

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