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.