Vetter Provides Services for Sterile Water for Injection with 5 Years Stability Data
Vetter now offers its filling services for high-quality sterile water for injection (sWFI) syringes with 5 years of stability data. Such sWFI syringes can be used to complement to lyophilized drugs in vials, and Vetter's
Vetter’s stability data and bracketing concept allows a longer shelf life for drugs, and high flexibility while defining the filling volume, the company reports in a press release. Vetter also offers "ready-to-submit" documents for the sWFI service in Common Technical Document (CTD) format to hasten the approval process.
“Lyophilized drugs are an international growth segment for CDMOs,” states Peter Soelkner, Managing Director of Vetter, in the press release. "An ever greater number of manufacturers are looking for options to enable a safe and simple administration of these drugs. Our filling service for WFI syringes represents a reliable and patient-friendly solution offering our customers high-flexibility due to Vetter’s bracketing concept, and fast time-to-market by using the ready-to-submit documents. In addition to documents for approval in the USA and Europe, we also have all the necessary documentation for Japan available for pharmaceutical and biotech firms, which can considerably abridge the approval process.”
Vetter’s sWFI syringes is available in 1.5 ml formats with a volume of 0.5 ml to 1.3 ml, as well as a 3-ml format with a volume of 1.4 ml to 3.0 ml. The syringe employs Vetter’s V-OVS tamper-evident closure. Vetter can provide ICH compliant and ready-to-submit documentation for the USA, Europe, and Japan. Validation and stability data according to USP, Ph.Eur., Ph.J., and ICH guidelines are also available.
Vetter can manufacture batches of up to 120,000/140,000 pieces, the company reports.