Eurofins expands compendial container and packaging testing capabilities with new autoclave
Heather Cawley, Principal Scientist, Pharmaceutical Raw Materials, Eurofins BioPharma Product Testing
Meeting the rigorous demands of compendial autoclave testing presents a unique set of challenges for pharmaceutical laboratories. From ensuring precise control over sterilization parameters for various size containers, to maintaining compliance with global pharmacopeial standards, laboratories must navigate complex technical and regulatory requirements to deliver reliable results. At Eurofins, we understand these challenges firsthand.
Eurofins brings more than two decades of expertise, testing various pharmaceutical containers, elastomeric closures, and packaging systems per USP, EP, and JP requirements. We’re proud to announce we are integrating the Systec® HX-320 autoclave into our laboratory operations.
This advanced autoclave will enable us to perform container testing in complete alignment with compendial requirements. The HX-320 offers programmable cycles and precise control over temperature, pressure, and cooling which are essential for achieving consistent and accurate results.
To ensure optimal performance, the system will undergo extensive Performance Qualification (PQ) activities across a wide range of autoclave loads and cycle programs. It is also equipped with 21 CFR Part 11 compliant software and robust data integrity controls supporting regulatory compliance. This enhancement reflects our continued commitment to delivering high-quality, dependable testing services to the pharmaceutical industry.
As we continue to make progress on installation and qualification activities, Eurofins is targeted to offer testing services with the Systec HX-320 in early 2026. If you have upcoming container testing needs or questions about how our team can support your project, we encourage you to: Contact Us