Prefilled Syringe (PFS) and Cartridge Filling
Patient-centric drug delivery innovations are rapidly evolving, particularly for the subcutaneous (subQ) administration of products. Pre-filled syringes, autoinjectors, and wearable devices can significantly enhance the user’s experience. Technological advancements in delivery devices now allow for the concentration of mAbs without compromising their efficacy or safety. Our new syringe and cartridge filling center ensures GRAM is at the forefront of client value delivery, significantly increases our capacity, and expands fill-finish services for emerging technologies.
GRAM offers aseptic filling services for the primary containers used in auto-injectors, which predominantly consist of syringes. Recognizing the industry trend towards larger volume primary containers, we have partnered with drug delivery experts to offer filling services for these containers beyond the typical 1mL or 2.25mL syringes. Visit our drug delivery partnerships page to learn more.
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 and critical filling steps for on-body delivery devices and autoinjectors.
1. 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 designed for modest demand or niche products filled in syringes and cartridges. Solutions for small to medium batch sizes without compromising quality are critical, and designs such as the VarioSys allow for 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
- Change parts for 1 ml and 2.5/3 ml syringes and 3 ml, 5 ml, 10 ml, and 20 ml cartridges.
- Modular isolator with fast and easily exchangeable filling modules allows rapid changeover from one process to another, as well as lower costs for customsized 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.
2. For your medium to high volume ISO syringes and cartridges.
GRONINGER UFVN Syringe Filler with SKAN Isolator
Our newest line is being designed for the growing biologics market, using the latest filling technology for 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 in 10 x 10 or 10 x 16 nested filling process
- 10-head peristaltic or rotary piston pump filler
- Change parts for 1 ml and 2.5 ml syringes
- 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.
- Qualification 4Q26