Using a sterilizing grade filter is one of the last steps in manufacturing of various drug products and formulations. Ensuring the filter is compatible with the drug product is a key issue to ensure sterility is achieved. During the sterilization process the product will go through a (0.22 µm) filter to remove microorganisms. Filter sterilization is most used with sterile drug products because other sterilization methods are not suitable or effective.
There are various industry guidelines that must be performed to meet the regulatory body requirements and assure the effectiveness of validating filtration sterilization. Most filter sterilization validations are in place to meet these regulatory requirements.
Nelson labs, offers a filter sterilization validation package. Within this package there are multiple tests that we run to validate your sterile filtration process in a timely manner. In this webinar you will learn what sterilizing grade filtration is, how it is applicable to the industry, and the tests we offer to help you, and your company validate your filters for use, all while meeting regulatory requirements.
Presenter: Nate Fredrick