Compatibility testing
Evaluates filters and SUS components for system integrity after exposure to worst-case fluid and process conditions
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When to validate filters
Understand more about when and how filter validation should be applied to aseptic processing.
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White Paper: A risk-based approach to validation studies for sterilizing filtration and single-use systems
Learn more about how to design a risk-based approach to validation of filters and SUS components.
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Report: Application of our Sterility Optimization by Assessment of Risk (SOAR) program
Report outlines our recommendations for applying risk management principles to sterile filtration.
The foundation of process-specific filter validation is bacterial challenge testing. We offer bacterial retention tests demonstrating the ability of a filter to produce sterile effluent under the worst-case process conditions with a minimal challenge concentration of ≥1 × 107 CFU/cm2 of filter membrane area.
Adsorption testing
Optimizes filtration process to ensure product meets QC specification, including minimal product loss by adsorption
Product wet integrity testing
Facilitates filter integrity testing by developing product-specific integrity test values
Extractables and leachables (E&L) are chemical compounds that can potentially migrate into the drug product from process equipment, affecting safety, quality, and potency.
Cytiva offers consultancy and formal reports that can be used to support a comprehensive risk assessment that may negate the need for process-specific E&L studies.
We offer support for regulatory responses on behalf of the end user, including:
- Technical support to address any regulatory feedback regarding SUS/filter validation
- Assistance with any proposed manufacturing changes that could have an impact on the final sterilizing grade filter/SUS
- Technical rationale for product grouping where applicable