Novel, high-tech line fully validated; first customer project underway
Ravensburg, Germany, April 8, 2013 / B3C newswire / – 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.”
Vetter webinar “Navigating the future of aseptic manufacturing”
Register today for the free, live webinar and find out how to meet challenges in aseptic manufacturing with your CDMO. This live event will take place Tuesday, April 16, 2013, at 10:00 AM EST.
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States.
Vetter Pharma International GmbH
Phone: +49 (0)751-3700-3023
Fax: +49 (0)751-3700-7707