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Prefilled Syringes for Medical Devices Manufacturing

AbbVie's decades of experience with high viscosity formulations, complex regulatory environment, and operational excellence enables AbbVie to be a leader in supplying sterile prefilled syringes for the medical device market. Filling viscous material into syringes demands specialized expertise. AbbVie CMO puts that expertise and experience to work for you, delivering high quality

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AbbVie's Value for Sterile Prefilled Syringes for Medical Devices

AbbVie Contract Manufacturing offers manufacture of prefilled syringes for medical devices through our Pringy facility near Annecy, France — AbbVie's global Center of Excellence for sterile filling of prefilled syringes for medical devices.

High viscosity formulations present unique challenges at every stage of the manufacturing process. Standard filling equipment struggles with flow characteristics. Compounding requires precise temperature and mixing controls. Quality testing must account for rheological properties that differ fundamentally from standard liquid formulations.

These challenges multiply when the final product is regulated as a medical device, and therefore is subject to device regulations in addition to requirements of pharmaceutical grade sterile filling of drug products. The manufacturing partner must demonstrate expertise in both sterile filling and medical device requirements — a combination that narrows the field of qualified CDMOs significantly.

With AbbVie CMO, our partners gain access to decades of hydrogel experience, integrated development and operations at a single location, and a proven track record with highly viscous products. Let's talk about AbbVie CMO's sterile prefilled syringe filling for your medical device today.

Understanding the Prefilled Syringe Medical Device Manufacturing Process

Prefilled syringe medical device manufacturing is a multi-step process that requires specialized equipment, trained personnel and validated processes at every stage.

The, process begins with bulk product preparation which includes compounding of the formulation, chemical cross-linking and purification of the cross linked product for hyaluronic acid based formulations— a critical step for high viscosity products where temperature control, cross-linking parameters and batch consistency directly impact final product quality. From there, the bulk product is filled into nested syringes, followed by terminal sterilization, automated visual inspection, and on-site release testing. Sterile prefilled syringes are then labeled, customized with finger grips and plunger assembly and packaged into blisters and cartons to meet your patient’s needs..

For high viscosity compounds such as hyaluronic acid and other hydrogels, each step requires equipment and processes specifically configured for viscous materials. This is one of the main reasons why AbbVie CMO has invested in purpose-built capabilities at our Pringy facility.

Our Formulation & Development Services

What distinguishes Pringy from other contract manufacturing options is the integration of development with Operations at a single location. This integration accelerates tech transfer, reduces handoff risk and enables faster problem-solving during scale-up and commercial production.

The site has decades of experience with hydrogels and is configured specifically to manufacture highly viscous products and their unique manufacturing requirements.

Extensive formulation and scale-up experience with high viscosity compounds
Process optimization and technical transfer support
On-site analytical and quality testing capabilities

Manufacturing Equipment & Process Capabilities

At AbbVie CMO, we leverage our extensive experience to give your product an inside edge. Our Pringy facility operates three separate filling suites: two high-speed commercial lines and one semi-automated clinical/launch line.

Bulk Product Preparation: 5 to 25 L batch size with proven experience compounding, chemical cross-linking and purifying highly viscous gels
Syringe Filling: 5-head fillers with the ability to glass or plastic syringes 1-10 mL in size in nested format
Post-Fill Operations: Heat/steam terminal sterilization, automated visual inspection, and full QC release testing on-site
Assembly & Packaging: Fully automated assembly of finger grips and plungers, syringe blistering, final packaging including carton and corrugate

On-Site Analytical & Quality Testing

Pringy maintains a full suite of analytical testing capabilities on-site, including QC release. This eliminates delays associated with third-party testing and keeps quality control within the same operational framework as manufacturing.

Analytical Testing: HPLC, UPLC, Spectroscopy (IR, UV), Rheology, Subvisible and visible particles
Microbial Testing: Bioburden, Endotoxin, Sterility
Device Testing: Break loose force, Glide force, Tip cap pull off force, Leak test

For more information on our broader fill finish capabilities, download our Prefilled Syringe for Medical Devices cutsheet.

Challenges Companies Face with Prefilled Syringe Medical Device Manufacturing

Prefilled syringe medical device manufacturing for high viscosity formulations is uniquely challenging because it requires specialized equipment, thoroughly trained personnel and validated processes. Some common challenges include:

Difficulty with high viscosity flow characteristics during filling
Maintaining formulation stability and consistency
Precise temperature and mixing controls during compounding
Regulatory compliance for combination products and medical devices
Quality testing for rheological properties
Finding a CDMO with proven hydrogel experience

From Clinical to Commercial Scale

The semi-automated clinical/launch line at Pringy supports early-stage programs and product launches, while the two high-speed commercial lines provide capacity for established products. This configuration allows partners to scale within a single facility, maintaining process continuity and regulatory documentation from clinical batches through commercial production.

Learn more about our Pringy facility and its full range of capabilities.

Choosing the Right Partner for Manufacturing of Sterile Prefilled Syringes as Medical Devices

Our team's extensive clinical and commercial experience with medical device manufacturing allows for a seamless transition at any stage while ensuring all levels of global compliance. We have the expertise as a leading global pharmaceutical organization to anticipate all potential challenges and carefully plan your project to ensure successful patient outcomes.

For more information about our prefilled syringe medical device manufacturing services or next steps to get started outsourcing your medical device manufacturing today, contact us here for further details.

An AbbVie CMO representative is eager to talk to you.

AbbVie CMO is a seasoned partner for all your contract manufacturing needs. Let’s start a conversation today. The future is a click away.

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