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 these challenges.

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 prefilled syringes.

Will the course address some of the newer, more flexible technologies available for prefilled syringe manufacturing, such as robotic filling lines, compartmentalized isolators, etc.?

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 environment?

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 production.

What technologies and equipment will students be using in the handson sessions?

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 products.

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 drugs.

Learn more about the course "Development and Manufacturing of Pre-filled Syringes."