Prefilled Syringe (PFS) and Cartridge Filling
Biologic drugs continue to evolve, creating new demands for innovative drug-delivery devices and primary containers for prefilled syringes and cartridges. The transformation of Contract Development and Manufacturing Organizations (CDMOs) in their skill sets and equipment is evident as they adapt to better serve their clients. These devices must meet specific requirements concerning quality, rapid market entry, production capacity, and successful commercial launch.
As technology advances, customer and regulatory expectations become higher. It is crucial to engage the right personnel and invest in modern equipment to comply with current standards. Our new syringe and cartridge filling center positions GRAM at the forefront of delivering value to clients, significantly increasing our capacity and expanding our fill-finish services for emerging technologies.
By partnering with an experienced CDMO, pharmaceutical organizations can concentrate on their core competency: developing new therapies and solutions for patients.
GRAM Has Two Lines That Offer Different Solutions
We aim to give our clients the ultimate versatility to scale their products and succeed in the marketplace. To do so, GRAM invested in two filling lines supporting syringes and cartridges, as well as critical filling steps for on-body delivery devices and autoinjectors.
1. For your medium to high volume ISO syringes and cartridges.
groninger UFVN Syringe Filler with SKAN Isolator
Our newest line is designed for the growing biologics market, using the latest filling technology to achieve the tightest manufacturing controls for critical drug-device parameters. A high-speed line, the groninger 10 Head UFVN Syringe Filler with SKAN Isolator supports larger batch sizes.
- Syringes and cartridges nested filling process
- 10-head peristaltic or rotary piston pump filler
- Syringes from 1 mL to 10 mL
- Cartridges from 1.5 mL to 20 mL
- Denesting of syringes with linear movement of syringes to maximize Annex compliance (First Air principle)
- 100% IPC for weighing, stopper placement, and needle shield verification.
- Downstream renester and automatic rejects removal
- In-line automated visual inspection.
- Available Q1 2027
2. For your low to medium-volume products or custom drug delivery innovations
Bausch+Ströbel VarioSys® Syringe and Cartridge Filler with SKAN Isolator
Our modular line, the Bausch+Ströbel VarioSys with SKAN Isolator, is ideally suited for low-volume applications or niche products filled into syringes and cartridges. Solutions for small- to medium-sized batch sizes without compromising quality are critical, and designs such as the VarioSys enable component flexibility and product segregation without the expense of separate filling lines.
- Syringes and cartridges in a 10 x 10 nested filling process
- Two-head peristaltic or rotary piston pumps
- Syringe change parts for 1 mL, 2.25 mL, 3 mL
- Cartridge change parts for 3 mL, 5 mL, 10 mL, 20 mL
- Modular isolator with fast and easily exchangeable filling modules allows rapid changeover from one process to another, as well as lower costs for customized change parts.
- Compact size minimizes drug substance (DS) loss and provides maximized batch yields.
- Maintenance, cleaning, and filling module setup occur outside the isolator, thus optimizing filling line utilization.