Sterilization Engineering

Sterilization Engineering is a specialist engineering capability within Kymanox focused in supporting the application, execution, and quality of sterilization processes. Sterilization experts at Kymanox take a risk-based, analytical approach to help our clients develop sterilization solutions to address their unique needs.

Sterilization Capabilities

These services include, but are not limited to, the evaluation of formulation technologies, the selection and optimization of drug product formulation, and the evaluation of manufacturing process technologies, process development, scale-up, and technology transfer.

Initial Planning and Design

Kymanox can help clients identify their sterilization needs and options by conducting an initial device sterilization capability assessment, comparing methods and making recommendations for a product-specific sterilization method, and assisting with material selection.

Development and Optimization of Sterilization Processes

Our sterilization experts can design and optimize sterilization process for all FDA established Category A methods (e.g., dry heat, ethylene oxide, steam, irradiation) as well as several FDA established Category B methods. We can also develop processes for novel sterilization methods.

Sterilization Process Analyses

Kymanox can conduct sterilization processes analyses including dose uniformity calculations for all radiation sterilization processes, gas diffusion and heat transfer analyses, optimized exposure determinations for bioburden methodologies, and most resistant site determination.

Sterilization Validation

Kymanox sterilization and validation experts assist clients with cleaning, disinfection, and sterilization validations, sterility assurance, Sterile Barrier System (SBS) and Container Closure Integrity (CCI) testing, residuals testing, and bioburden reduction.