Compatibility testing
Evaluates filters and SUS components for system integrity after exposure to worst-case fluid and process conditions
Looking for Pall Accelerator™ validation services? We're still here – only now, part of Cytiva Fast Trak™ validation services for sterilizing-grade filters and single-use components.
Pall Life Sciences has always been at the forefront of establishing best practices and industry guidance. Becoming part of Cytiva has allowed us to offer even more. Whether it's microbial retention testing, E&L, PUPSIT, and more, you're in good hands with our improved Fast Trak™ validation services.
Critical sterilizing filter validation
When manufacturing a drug product, the final sterilization process must be validated to meet global regulatory requirements. We offer validation expertise covering a wide range of Cytiva sterilizing-grade filters and single-use system (SUS) assemblies.
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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.
Microbial retention testing with our Fast Trak™ validation services
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
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.
PUPSIT
Pre-use post-sterilization integrity testing (PUPSIT) is used to verify the integrity of the sterilized filter before use. We can provide you with documentation or perform testing to support your risk assessment needs.
Tailor-made solutions
One size does not fit all. We will consult with you to create the right, custom solution to fit your needs according to your phase of process development. Our wide array of services include risk assessments to support sterile filtration for early clinical phase products, and support to ensure sterility assurance.
Regulatory support
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