FAQs

Sterigenics operates 48 facilities in 13 countries to ensure medical devices, pharmaceutical products, and food are safe for people to use and consume.

Sterigenics sterilizes and decontaminates products that protect over one million patients and consumers every day.

This includes surgical instruments, catheters and procedure kits, IV administration sets, personal protective equipment (PPE) such as drapes/gowns, wound protection sleeves, tubing sets and many more.

Without these essential devices, vital procedures would not occur and patients’ lives would be at risk.

As explained by the FDA, for many medical devices, sterilization with EO is the only method that effectively sterilizes and does not damage the device during the sterilization process.

Approximately 50% of sterile medical products in the U.S. are sterilized using EO.

Without EO sterilization, infection risk associated with surgical procedures and other forms of care could be meaningfully increased.

Sterigenics provides sterilization services using Gamma, EO, E-beam and X-ray technologies.

Sterigenics does not determine which sterilization method to use. The method of sterilization is determined by FDA sterility requirements and the medical product manufacturer based on the materials and the design of the product being sterilized.

In late 2019, the FDA stated, “there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”

In August 2022, the FDA stated “…other methods of sterilization cannot currently replace the use of EO for many devices.”

EO is in the air around us.

EO is a common building block in many of the products we use in our daily lives, including household cleaners, personal care products and pharmaceuticals. It is also emitted by ordinary cooking activities, from car and truck engines and natural gas combustion, and is produced naturally by plants and the human body.

Yes. Sterigenics’ facilities have been industry leading, consistently outperforming environmental regulatory standards for decades.

After further review, SCAQMD has determined the facility could pose an increased cancer risk to at least 5, and at most approximately 30-40, off-site workers near the facility if exposed to levels of EO emissions continuously for 25 years.

We are evaluating additional protection measures to provide additional protection, further enhancing our already safe operations.

Sterigenics has successfully completed remediation efforts to address the previously announced SCAQMD notices of violation.

The agreement is not an admission of a violation or threat of violation.

If the facility ceased operating, there would be a significant risk of medical device shortages. The FDA has determined that there is not enough EO sterilization capacity across the US, and many devices are only approved for sterilization at a specific site and in specific chambers at that site.

Sterigenics also provides over 40 well-paying industrial jobs in the area.

Sterigenics has and continues to operate safely and disagrees that its operations create any meaningful risk to anyone, including nearby offsite workers. To the extent there is any risk, Sterigenics disagrees that this violates any rules.