Using a sterilizing-grade filter is one of the last steps in the manufacturing of various drug products and formulations. Ensuring the filter is compatible with the drug product is a key issue to ensure that sterility is achieved. During the sterilization process the product will go through a filter (0.22 µm) to remove microorganisms. Filter sterilization is most often 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 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 package for filter-sterilization validation. Within this package there are multiple tests that are 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 which tests Nelson Labs offers to help you and your company validate your filters for use as well as meet the regulatory requirements.