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
The PDA Letter reached out to Koller who
provided an overview of the course.
What test methods will the course
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
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
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