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Development and validation of a rapid sterility test: Company Experience Back CONFARMA France, quality control expert.

The implementation of alternative methods to control microbiological quality is an investment project that affects more and more of the world of health industries. The validation of an alternative system for this sterility test challenges as verification of the applicability of a product on a new technology. Several issues can be encountered during the validation phase:

  • product compatibility with the technical
  • Generating results "false positives"
  • Neutralization of the antimicrobial activity on innovative technology
  • Interference with the product technology
  • Comparability of the alternative method with the traditional method

This workshop will address these issues from the perspective of CONFARMA France, who will provide feedback on the technology Milliflex® Rapid using examples encountered during validations on its customers' products.

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