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Answers to important questions, summary of the benefits to Tucson, and a link to the permitting process documents

Benefits to Tucson:
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FAQs

Medical device sterilization is essential to a functioning and effective health care system. We sterilize our medical devices in order to protect patients from the risks of infectious diseases caused by bacteria, viruses, and fungi. Sterilization of medical devices is required by the FDA to ensure patient safety.

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.

Yes. This process is used at BD and numerous other medical device companies and third-party sterilizers.
BD has been sterilizing medical devices for more than 50 years.
Given the advanced technology and controls being built into the new facility, PDEQ has determined that the emissions from the facility will be controlled to levels well below the EPA risk threshold.
About 50% of all medical devices produced globally are sterilized with EtO. The products which will be sterilized at this facility can only be sterilized with EtO.
The facility and equipment are designed to minimize the potential for accidental release of EtO. This includes enhanced process monitoring and control, leak detection, and fail-safe instrumentation and controls. In addition to state-of-the-art systems, robust operational and maintenance procedures will ensure safe operation of the facility.

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.
BD has many safeguards in place to ensure the safety of our employees and to ensure compliance with OSHA requirements for EtO. We employ fixed gas monitoring systems to monitor EtO levels in our facilities on a continuous basis. In addition, individual associate exposure studies will be conducted in accordance with OSHA requirements using standard industrial hygiene methods and laboratory analysis through an Accredited Lab.
BD provides rigorous training for our employees, and we have very detailed process safety controls and procedures. Training includes a combination of classroom and hands-on training. This will include testing, and demonstration of mastering the required skills and knowledge.
The site is located in an industrial area zoned specifically for this type of operation. The facility will be centrally located between eight manufacturing sites and three distribution centers. Tucson boasts a strong labor pool and business friendly environment and increases our capabilities and capacity in North America and for the U.S. supply chain.
BD makes a range of medical devices that will be sterilized at this facility. BD manufactures a wide range of devices from syringes to catheters to stents to surgical devices and much more. These are products that are necessary for a functioning health care system.
Maximum potential emissions are well documented in the permitting process and will be controlled to levels well below the EPA risk threshold.
In addition to job creation and an estimated economic contribution of $122 million over 10 years, BD has a track record of being productive members of our communities. For example, our BD Peripheral Intervention business is headquartered up the road in Tempe, and they partner and support numerous local non-profits and received the Tempe Chamber Large Business Excellence award this year along with being named Arizona Bio Business of the Year in 2017 and 2020.
The construction process will be implemented to minimize impact to the area. We do not anticipate any disruption to traffic or negative impact to surrounding areas. Dust control will be managed in compliance with PDEQ and EPA requirements.

Documents

Link to the Pima County Environmental quality page for the BD permitting process documents.

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