As drug device combination products grow more complex, pharmaceutical manufacturers face increasing pressure to ensure sterility without compromising product performance or patient safety. This case study highlights how Sterigenics partnered with a pharmaceutical company to implement a customized ethylene oxide (EO) surface sterilization strategy for an auto injector following aseptic fill finish, enabling sterility at the point of administration while preserving drug stability and device integrity. Supported by expert advisory services and integrated testing from Nelson Labs, the validated approach addressed regulatory, design, and supply chain challenges—demonstrating how advanced sterilization expertise can reduce risk, build confidence, and accelerate successful commercialization of complex injectable therapies.
