The prefilled syringe market has grown considerably over the past decade. A number of innovative prefilled syringe products are now available to patients. But, like any other parenteral container, these products must undergo compliance testing. Horst Koller, CEO, HK Packaging Consulting, and Roman Mathaes, PhD, Senior Group Leader, Lonza Drug Product Services, will present the course, “Test Methods for Pre-filled Syringe Systems,” that follows the 3rd PDA Europe Annual Meeting.

The PDA Letter reached out to Koller who provided an overview of the course.

What test methods will the course cover?

The course looks at the combination of a syringe cartridge with a delivery device. The system functionality needs to be proven over the complete shelf life of the combined system. We will also cover the safety systems around prefilled syringe systems.

What regulatory requirements will be addressed?

We will address the regulatory requirements for three types of products:

• empty prefilled syringes ready for filling
• final filled product
• combination products, such as autoinjectors

If I have some years of experience, what can I get out of the course?

It provides a good overview of the complete lifecycle of a prefilled syringe in general. From the basic idea of a syringe as a primary container to the functional, biological and regulatory performance of a prefilled syringe, including functions for delivery devices. This can be very complex. This is a chance for someone who works solely in manufacturing to understand the development of a prefilled syringe and vice versa.

What materials will the course cover?

It will cover glass and polymer containers.

How will the course be structured?

We will give an introduction and then go from there. Interaction between the attendees and instructors is very important for this course. In fact, we plan for it to be an interactive session for the complete two days. Students are welcome to ask questions as we work through the various topics.

Learn more about the PDA Education course, Test Methods for Pre-filled Syringe Systems.

About the Expert

Prior to becoming a consultant, Horst Koller worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 20 years of industry experience. His consulting company focuses on technical, regulatory and quality metrics support around primary and secondary packaging systems, including medical devices.