Pre-use/post-sterilization Integrity Testing of Sterilizing Grade Filter:

摘要

Sterilizing grade filtration has been used for decades with reliability and assurance. The reliability of this particular aseptic processing step increased with filter stability improvements, robust integrity test methodologies and especially process validation requirements, which evaluate the performance of a particular sterilizing grade filter under process conditions utilizing either the actual fluid or a placebo, if the fluid is bactericidal or bacteriostatic (1-3).