Answers to important questions, summary of the benefits to Tucson, and a link to the permitting process documents
For a large number of medical devices, EtO is the only option for sterilization due to material sensitivities and/or the complexity of design. Many devices can be damaged by moist heat, radiation, and other modes of sterilization.
We want to be clear: We simply would not operate a facility that puts our employees, vendors, or the community at risk.
As part of our commitment to safety, BD’s Environmental Health and Safety standards ensure that all BD facilities are designed and operate with a high level of process safety and environmental controls.
Our facility in Tucson will employ state-of-the-art emission controls to minimize the amount of EtO released to the atmosphere and will be one of the most sophisticated EtO sterilization facilities in the world at capturing EtO. These emission controls will reduce the amount of EtO released to the atmosphere substantially below US EPA’s acceptable human exposure risk level.
BD uses the best available emission control technology in the industry. EtO from the sterilization chambers and degassing cells are captured and treated using catalytic oxidation. This achieves >99.95% destruction of EtO, significantly greater than the 99% required under the Clean Air Act. Off-gassing emissions from the warehouse section of the facility are captured and treated using a state-of-the-art capture and treatment system. These systems are maintained in strict accordance with manufacturer recommendations and tested in accordance with the requirements outlined in our air permit.
BD verifies the effectiveness of emission destruction through stack testing (conducted by an independent third-party), in accordance with permit requirements. In addition, when the catalytic oxidizer is running at its specified temperature range, the EtO destruction results are extremely consistent and predictable. We will have 24/7 monitoring of temperature data and several other key operational parameters. If the temperature deviates from specified levels, we have controls so the whole system automatically shuts down to avoid unintentional ethylene oxide release.In addition, we have operators and engineers who pay very close attention to all of our equipment. We will perform an annual maintenance shutdown to thoroughly inspect and maintain all sterilization equipment including the catalytic oxidizer.