Description
Theraxel is a consulting, auditing, and training company specialized in contamination control within the manufacturing processes of healthcare products, taking into account regulatory requirements while integrating the management of specific controlled environments.
We provide our expertise to ensure that medicines—particularly those derived from biotechnologies—are pure, safe, and effective, manufactured according to the correct formulation and free from contaminants (environmental, chemical, and biological).
From the Research & Development stages through to industrial production, Theraxel supports industry stakeholders in securing their processes, ensuring the reliability of their production environments, and sustainably optimizing their operational performance.
Working closely with field operations, our expert consultants combine technical expertise, operational pragmatism, and mastery of international regulations to deliver concrete, effective, and implementable solutions.
Theraxel also conducts investigation missions in contamination situations, supporting industrial performance while ensuring patient safety and risk control.
Our teams operate in the following areas: Sterility Assurance, Surface Control (Cleaning/Disinfection/Bio-decontamination), Qualification and Validation of Cleanrooms (including smoke tests), equipment qualification (autoclaves, depyrogenation tunnels and ovens, lyophilizers), and specific process validation (aseptic processes, terminal sterilization, Cleaning/Disinfection).
We also provide expertise in Operational Quality Assurance, Biosafety, Quality Risk Management (QRM), and on-site operational troubleshooting.
In addition, we complement our consulting services with professional training programs, delivered either in-company or inter-company, specifically designed for your teams through our certified training organization.