VALIDATION OF STERILIZING GRADE FILTRATION
“A sterilizing grade filter is one that sterilizes the drug product.” Peter Cooney, Ph.D., FDA CDER.
PDA Technical Report # 26.
CENEBA Filter validation services are designed to meet customer specific needs and help achieve regulatory compliance are include the following tests:
All of these studies are executed under pre-approved test methologies establishing the test conditions and acceptance criteria.