Interaction between drug delivery system
and drug product. Quality Control.
Stability. These are some of the extra
concerns that pharmaceutical manufacturers
face when producing prefilled syringes.
Sterile products have always presented
challenges but prefilled syringes amplify
In light of this, PDA Europe is offering a
new, two-day course on prefilled syringe
manufacturing following the Universe of
Pre-filled Syringes and Injection Devices.
The PDA Letter spoke with instructor
Egmont Semmler, PhD, Director R&D
Pharmaceutical Fill and Finish, Groninger,
about the new course.
What spurred the development of
this new course?
The course, “Development and Manufacturing
of Pre-filled Syringes,”covers the
latest trends in prefilled syringes, aseptic
manufacturing and drug delivery. We have
been working on this course with several
partners to deliver a complete picture of
the manufacturing process from forming
to nested objects, testing and visual
inspection, container closure, regulatory
aspects and, finally, insertion into drug
delivery devices. We especially focused
on practical, hands-on applications so
that students will have the opportunity
to perform and understand key aspects
(particles, siliconization, elastomers for
closures, plunger testing, filling) around
Will the course address some of the
newer, more flexible technologies
available for prefilled syringe
manufacturing, such as robotic
filling lines, compartmentalized
Yes, the course will also address these emerging
technologies and their benefits to the
manufacturing process for prefilled nested components. Where applicable, we will go
in depth and discuss the risks and benefits.
How will the course address
manufacturing in an aseptic
It will address aseptic manufacturing
throughout the entire prefilled syringe
product lifecycle, starting with the glass
forming/injection molding process for a
glass/plastic syringe and the requirements
to control particle load and microbial
ingress, continuing to aseptic processing
in filling to insertion into drug delivery
devices. The most important aseptic
concepts, e.g., RABS and isolators, will be
discussed with a focus on prefilled syringe
What technologies and equipment
will students be using in the handson
The students be able to turn lecture
contents directly into practical experience
using our trial equipment. We will have
equipment for siliconization, filling, stoppering,
qualitative function testing and
quantitative particle/siliconization testing.
Furthermore, we will have a number of
samples of prefilled syringes from different
manufacturing steps, from raw materials
to a fully integrated device, so the
students can experience the look and feel
to enhance their understanding.
Who would benefit from this course?
This course would be of value to pharmacists,
engineers and anyone dealing with
prefilled syringes on a daily basis who
wants to understand them more in depth
and how they differ from traditional parenteral
I also welcome professionals from adjacent
fields who want to broaden their perspective
on prefilled syringe manufacturing.
As an instructor, what is your main
goal for this course? What do you
want students to take away from it?
I sincerely hope that students will enhance
their understanding of prefilled syringes
as a primary container for their drug and
drug delivery systems. Students should be
able to evaluate and determine root causes
of potential failures around prefilled
syringes. Additionally, they will have the
tools to prevent these issues by choosing
the right delivery system and closure upfront
along with awareness of the detailed
interactions between prefilled syringes and
Learn more about the course "Development and Manufacturing
of Pre-filled Syringes."