Sterile Liquid Injectables: Aseptic fill on a state-of-the-art fill / finish crimp-cap line, capable of aseptic filling 1 – 125 ml vials. We have validated processes in place for sterile filling 2, 3, 5, and 20 ml vials up to 15,000 units per run.
Supporting our process equipment are validated services including a WFI system, pure steam generator, autoclave and depyrogenation oven. Validation capabilities include, but are not limited to, aseptic fill simulation studies, terminal sterilization loads, autoclave loads, depyrogenation oven loads, container closure integrity and process validation. Dalton also has the ability to develop or transfer technology related to aseptic processing. In addition, Dalton’s analytical service laboratory offers method development, validation and ICH stability programs to its clients. QC/QA, Microbiology support all analytical data.
We are currently manufacturing sterile clinical trial products under cGMP at Dalton.