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.

Filter and single-use component compatibility testing

Compatibility testing

Evaluates filters and SUS components for system integrity after exposure to worst-case fluid and process conditions

Normal flow filtration pictogram

Adsorption testing

Optimizes filtration process to ensure product meets QC specification, including minimal product loss by adsorption

Product wet integrity testing

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