This specialized case study explores Kymanox’s approach to optimizing terminal sterilization for temperature-sensitive pharmaceutical vials and Prefilled Syringes (PFS) through advanced process modeling and rigorous validation. Our team of SMEs collaborated closely with stakeholders to implement measurable improvements across sterility cycle design, product stability, and regulatory compliance to enable a commercially viable solution.
CHALLENGE
SOLUTION
RESULTS
- Client needed to terminally sterilize a pharmaceutical product in vials and develop a viable process for PFS.
- Product was temperature-sensitive, showing unacceptable degradation at standard steam cycles.
- Initial attempts at steam sterilization were only marginally unsuccessful, requiring process optimization.
- Educated Client on steam sterilization process requirements and validation standards.
- Evaluated multiple sterilization cycle options to optimize thermal transfer and achieve microbiological effectiveness without compromising product quality.
- Performed thermal metrology and microbiological testing across different sterilization profiles to assess feasibility against target lethality (Fo) and biological indicator (Fbio) levels.
- Identified an Arrhenius-type relationships between degradation and time/temperature exposure and developed a predictive model to inform cycle design.
- Optimized the sterilization cycle by balancing microbial inactivation parameters (D-value, Z-value) with minimal product degradation.
- Validated the optimized cycles on both vials and PFS, and developed validation plans and protocols for third-party execution.
- Successfully delivered a commercially viable terminal sterility process based on Quality by Design (QbD) principles rather than trial and error.
- Enabled process development informed by predictive modeling, providing confidence in sterilization tolerances, product quality control, and scalability for future production.