The new 120,000 square-foot facility will be built on approximately 32 acres in an industrial zone located at the northeast corner of Valencia and Kolb Road and is planned to be operational in mid-2023.
BD will construct a state-of-the-art, final-stage manufacturing and sterilization facility in Tucson, Arizona, that will be an integral part of the U.S. medical device supply chain and expand the footprint BD already has in the state, which includes a $1 billion BD Peripheral Intervention business unit in Tempe.
The facility plans to add approximately 40 new high-wage jobs, including engineers, scientists, quality control specialists, and other skilled positions. The new 120,000 square-foot facility will be built on approximately 32 acres at the northeast corner of Valencia and Kolb Road and is planned to be operational in mid-2023. The site is located in an industrial area, not a residential area, and emissions will be significantly below the EPA risk threshold for this type of facility.
As part of the company’s response to COVID-19 and commitment to public health, BD is investing significantly in its in-house capacity for manufacturing and sterilization. This facility will advance BD’s goals of improved overall operational efficiency, customer service levels, and supply chain resilience to avoid medical supply shortages in the U.S.
Our Tucson facility has been purpose-built to be one of the most efficient facilities in the world at capturing and controlling EtO
Ethylene oxide (EtO) is used to sterilize medical devices in order to protect patients from the risks of infectious diseases caused by bacteria, viruses, and fungi. EtO is the only sterilization option for a large number of medical devices due to material sensitivities and/or complexity of design such as urinary catheters, PICC lines, oncology ports, breast biopsy needles, vascular and ureteral stents, feeding tubes and more. The vast majority of EtO in our air comes from organic and industrial sources other than medical device sterilization facilities. EtO is a byproduct of combustion, meaning it is produced by campfires, grills, auto exhaust, lawn mowers and many other sources. EtO is found in rural areas where there are swamps and decaying debris. Even our own bodies produce EtO emissions. emissions. This facility will include advanced process emissions control technology (catalytic oxidation) and new fugitive emissions control technology (dry bed absorption). These state-of-the-art process control systems will monitor and control process conditions to ensure continued safety for personnel and the community.
Catalytic oxidation will be used to treat EtO emissions from the sterilizer and aeration cells, exceeding the National Emission Standards for Hazardous Air Pollutants (NESHAP) requirements for control efficiency by a wide margin. The fugitive emissions from the equipment rooms and post-sterile warehouse will be effectively collected and controlled using Advanced Air Technology® dry bed systems, ensuring the highest level of safety for the community.
BD’s philosophy for medical product sterilization is one of continuous improvement that leads the company to employ best available technology at our facilities. As technologies and processes evolve, BD routinely evaluates and voluntarily employs new technologies at our facilities when deemed appropriate.
BD uses the best available emission control technology in the industry. EtO emissions 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.
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 EtO releases.
BD verifies the effectiveness of emission destruction through stack testing (conducted by an independent third-party), in accordance with permit requirements. The testing methodology is reviewed and approved in advance of the testing by regulatory authorities.