Practical methods for the microbial validation of sterilizing-grade filters used in aseptic processing.

@article{Macdonald1989PracticalMF,
  title={Practical methods for the microbial validation of sterilizing-grade filters used in aseptic processing.},
  author={William D Macdonald and Cathy A. Pelletier and D L Gasper},
  journal={Journal of parenteral science and technology : a publication of the Parenteral Drug Association},
  year={1989},
  volume={43 6},
  pages={266-70}
}
Microbial challenge test methods to validate sterilizing-grade filters were developed to facilitate the use of parenteral drug products as liquid vehicles. Scaled-down filtration systems were developed in response to processing parameters, e.g., flow rates, pressures, duration, and temperature, provided by customers. Accordingly, 47 mm disc filter holders… CONTINUE READING