Our Fresenius Kabi US excellence center for prefilled syringes (PFS) is in Wilson, which is located in the eastern part of North Carolina. The Wilson site is a world-class facility with state-of-the-art, fully automated syringe technologies that are focused on the production and distribution of complex and critical drugs in ready-to-administer delivery systems and diluents, both for Fresenius Kabi and contract manufacturing partners.
The plant in Wilson is specialized in the formulation, syringe filling, and packaging of aseptic and terminally sterilized drug products and diluents with the advantage of being able to offer large-scale quantities and flexibility in the syringe portfolio and sizes. PFS drug products and diluents are produced on fully automated manufacturing, inspection, and packaging lines in a continuous process under controlled conditions. This highly automated and state-of-the-art manufacturing facility, half of which is dedicated to prefilled syringe production, has a unique capability and capacity to launch hundreds of millions of new and existing commercial PFS drug products including biologics, highly active compounds and products (maximum OEL = 0.1 µg/m3), and products that are sensitive to temperature, light, and/or oxygen.
Highly active compounds and products and biologics are able to be formulated and filled using new disposable single-use system technologies with completely disposable and/or dedicated product contact parts for reduced exposure levels. Products sensitive to oxygen can undergo nitrogen-filling technologies with light-protected palletization to achieve maximum shelf life and market value.
In Wilson, over 50 million PFS ready-to-administer pharmaceutical units are produced annually; including anesthetic, analgesic, antiemetic, anti-inflammatory, and a host of modifier and inhibitor therapeutic classes. These pharmaceuticals are filled in various configurations of syringes (Luer lock and/or staked needle) in volumes of 0.5 to 3 ml, and are inspected and packed in various configurations such as nested syringes of unlabeled bulk, as labelled and blistered (singles and/or sheets), and as cases, and/or are kitted with additional product(s).
This manufacturing facility is implementing additional automated state-of-the-art larger-volume PFS manufacturing lines, flow-wrapped packaging, as well as IV bags and standard solution bags based on Fresenius Kabi’s freeflex® platform. These implementations will create a unique possibility to launch products across multiple platforms specific to various product and customer requirements.
To support you with a global supply of your product, our Wilson plant has been inspected by various authorities including the US DEA and FDA, and is capable of serving the worldwide market, including key markets like the EU, China, Japan, Canada, Brazil , Latin America, and Australia. The plant is currently taking measures to achieve ISO quality and environmental certification ISO ISO14001 and ISO 50001. ISO14001 certification is scheduled for 2020. ISO50001 certification is scheduled for 2021.
We are proud to offer our partners the possibility of filling their solutions into syringes and freeflex® bags in Wilson, North Carolina. Please get in touch with us to find the perfect solution for your formulation and filling and finishing needs.
- Aseptic Pre-filled syringes filling
- Terminal Sterilization
- Critical care
- Pre-filled syringes (1 - 2 ml)