Novel, high-tech line fully validated; first customer project underway
Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new award-winning filling line at the company’s Ravensburg Vetter South facility is fully validated and ready for cGMP filling, after successful media-fill completion. One customer project is underway, with more in the wings. The line’s capacity ranges from mid- to large-volume batch sizes, with a maximum filling speed of 800 pre-sterilized syringes per minute. The line currently fills 1ml standard-format syringes, with additional formats to be added in the near and long terms. Featuring novel technologies that enhance safety and maximize API yield, it was designed to exceed cGMP requirements.
Highlights of the new commercial line, which features both speed and flexibility, include:
• Minimal human contact to enhance safety:
- Fully automated transfer of sterile packed tubs from preparation room to Class-A cleanroom and throughout the filling process. Includes a novel approach to zonal transition when moving tubs to higher cleanroom classes.
- Use of Restricted Access Barrier Systems (RABS).
• Novel disinfection techniques
- A special spray disinfection tunnel for bagged tubs, co-developed by Vetter and the equipment manufacturer.
• Optimized personnel and material flows
- One-way design to minimize potential for product mix-up and contamination risk.
• Advanced track and trace
- An end-to-end track-and-trace system with integrated scanners and printers, including automated disposal of rejects and sample removal following the filling process
• Techniques and technology to maximize API yield
- Optimized routing that shortens the distances between the compounding area and filling station.
- 100-percent, fully automated in-line control of syringe closures using a 3-D scanner prior to filling, to minimize API loss and reduce risk of contamination
- In-line monitoring of filling quantities using an automatic weighing system
Peter Soelkner, Vetter Managing Director, noted, “With our launch of the new filling line, Vetter continues to expand its prefilled-syringe capabilities due to increased customer demand.” He added, “Whether our customers require small-batch clinical fills or high-volume commercial fills, we can accommodate their needs.”