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UF Validation for Ultrafiltration

A pharmaceutical manufacturer must validate a pharmaceutical manufacturing process and the equipment in which it is operated. The general validation considerations are:.

  • Equipment must not affect drug product and efficacy
  • Equipment must not add unwanted contaminants to product
  • Equipment should be chemically compatible with feeds
  • System operation should be controllable

Additional validation run considerations include:

  • Maintaining process parameters within specifications during and throughout all runs
  • Predictable and reproducible product recovery from the TFF system
  • Product manufactured in the equipment has predictable and reproducible purity and activity and is effective and safe in the intended use
  • All maintenance procedures are shown to be effective, reproducible and reliable:

    • Cleaning to remove contaminants before reuse and to avoid cross contamination between batches
    • Sanitization to lower microbiological population and reduce the potential for contamination during a process run
    • Flushing to remove cleaning, storage, sanitizing and/or depyrogenating chemicals from the system before processing
    • Integrity testing of TFF filter and system

Developing and conducting a validation study that generates the data you require does not need to be difficult. Merck has experienced engineers and scientists able to help you navigate these issues with ease and ensure your ultimate success. We can help you:

  • Review your process to insure compatibility with best practices and methods
  • Test and ensure that the feed to be used in your validation study has the same performance characteristics as production feedstock (scale-down study)
  • Review and interpret results
Contact the Ultrafiltration Team to explore how we can help you avoid costly errors by verifying that your design falls within Merck ’s guidelines (actual process performance to be verified with optimization and process simulation trials).

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