Navigating government regulations with confidence

Facing the challenge of meeting changing United States’ Environmental Protection Agencies (EPA) regulations for ethylene oxide emissions monitoring can be daunting. However, with the right tools and support, it can become manageable. State-of-the-art solutions can detect the toxic ethylene oxide gas with precision, aiding in compliance navigation, ensuring smooth operations, and protecting workers in their breathing zone.

Meet the challenge with MAX-IR

Ethylene oxide (EtO) is used in applications such as medical equipment sterilization and chemical manufacturing. As a known carcinogen and air pollutant, it is critical to monitor to address both emissions and workplace air monitoring.

The Thermo Scientific MAX-iAQ Ambient Air Monitoring System and EMS-10 Continuous Emissions Monitoring System (CEMS) systems are ideal solutions for monitoring low-level EtO emissions in real time. They provide immediate detection of leaks and exceed US EPA standards with an LOD of 1 parts-per-billion (ppb) with less than 15 seconds responsivities. These robust and reliable systems require minimal downtime and low maintenance, ensuring your operations continue without interruption. Our comprehensive support includes technical expertise for installation, field service, and applications support.

Trust in a solution that safeguards indoor air quality and protects workers from potential exposure to this hazardous gas. With the right system, managing and reducing these risks becomes achievable, ensuring a safe and compliant workplace.

Read NESHAP rule to significantly reduce EtO emissions

The US EPA recently approved the final NESHAP rule to significantly reduce EtO emissions.

Let our team at Thermo Fisher Scientific help you successfully navigate this compliance challenge. Contact us today.

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  • Achieve fast, sensitive analysis for immediate detection of leaks
  • Exceed US EPA standards with an LOD of 1 parts-per-billion (ppb) with less than 15 seconds responsivities
  • Depend on robust and reliable operation with minimal downtime and low maintenance
  • Enjoy peace-of-mind with technical expertise including installation, field service, and applications support

Learn how the MAX-iR FTIR gas analyzers, using optically-enhanced FTIR (OE-FTIR) technology, overcome the specific challenges of monitoring EtO trace gases which presents difficulties due to low concentration and high reactivity.

Products

MAX-iAQ Continuous Ambient Air Monitoring system

MAX-iAQ continuous ambient air monitoring system

The MAX-iAQ is a fully automated, 20-channel ambient air monitoring system for addressing newly proposed regulations for worker safety. The system is capable of detecting ethylene oxide with a detection limit of 1 ppb and total cycle time of 10 minutes.

Learn more about the MAX-iAQ ›

EMS-10 Continous Emissions Monitoring System (CEMS)

EMS-10 continuous emissions monitoring system (CEMS)

The EMS-10 is a fully automated, four-channel stack emissions monitoring system that complies with the approved ethylene oxide NESHAP Rule. The system is capable of detecting ethylene oxide with a detection limit of 1 ppb.

Learn more about the EMS-10 ›

Comparing ethylene oxide (EtO) monitoring solutions

Comparing ethylene oxide (EtO) monitoring solutions

EPA regulations and compliance

Updates

In April 2023, the EPA released the Proposed Interim Decision (PID) and National Emission Standards for Hazardous Air Pollutants (NESHAP) to include more rigorous regulations for monitoring ETO for workplace exposure and stack emissions.

On March 14, 2024, the NESHAP Rule was approved. This will require commercial sterilizers to ensure certification and ongoing compliance of EtO CEMS emissions at the stack.

Learn more about EPA actions ›

Capitol Building EtO

What is the objective?

The goal is to decrease the release of EtO from these facilities by 90 percent, to levels below the Clean Air Act benchmark for elevated cancer risk, reducing exposure risk to workers and communities, while maintaining critical sterilization capabilities.

On-demand Webinar: Ethylene Oxide Emissions | FTIR Gas Analysis | Thermo Fisher Scientific - US

What companies will be affected?

The NESHAP Rule and proposed PID standard will affect the 88 commercial sterilizers operating in the U.S. currently – in addition to any new start-up companies that rely on EtO – by enforcing the installation of new pollution controls and technologies.

Industrial Building EtO

What is the expected impact?

  • Sterilization companies will be required to perform real-time monitoring of EtO that can measure concentrations at or below 10 parts ppb.
  • Data will need to be collected and reported to the EPA twice per year.
  • In facilities with EtO levels surpassing 10 ppb, additional safety measures, such as enforcing personal protective equipment (PPE) use, will be required.

Read the regulatory impact analysis ›

coworkers in discussion wearing protective masks

What is the proposed timeline?

Commercial sterilizers will have 24 - 36 months to comply with the new requirements once established. It is critical for companies to plan now, so that they are ready to make potential changes.

Project manager updating calendar tasks

How can we help facilities in the transition to compliance?

The EMS-10 CEMS and MAX-iAQ instruments, using new OE-FTIR technology, can identify and quantify low-level EtO leaks with a detection limit of 1 ppb, meeting EPA proposed standards.

The systems provide a proven, turnkey solution that combines fast, sensitive, and reliable emissions analysis with the technical expertise needed for smooth installation, calibration, and regulatory support.

virtual diagram for understanding regulations and standards

Updates

In April 2023, the EPA released the Proposed Interim Decision (PID) and National Emission Standards for Hazardous Air Pollutants (NESHAP) to include more rigorous regulations for monitoring ETO for workplace exposure and stack emissions.

On March 14, 2024, the NESHAP Rule was approved. This will require commercial sterilizers to ensure certification and ongoing compliance of EtO CEMS emissions at the stack.

Learn more about EPA actions ›

Capitol Building EtO

What is the objective?

The goal is to decrease the release of EtO from these facilities by 90 percent, to levels below the Clean Air Act benchmark for elevated cancer risk, reducing exposure risk to workers and communities, while maintaining critical sterilization capabilities.

On-demand Webinar: Ethylene Oxide Emissions | FTIR Gas Analysis | Thermo Fisher Scientific - US

What companies will be affected?

The NESHAP Rule and proposed PID standard will affect the 88 commercial sterilizers operating in the U.S. currently – in addition to any new start-up companies that rely on EtO – by enforcing the installation of new pollution controls and technologies.

Industrial Building EtO

What is the expected impact?

  • Sterilization companies will be required to perform real-time monitoring of EtO that can measure concentrations at or below 10 parts ppb.
  • Data will need to be collected and reported to the EPA twice per year.
  • In facilities with EtO levels surpassing 10 ppb, additional safety measures, such as enforcing personal protective equipment (PPE) use, will be required.

Read the regulatory impact analysis ›

coworkers in discussion wearing protective masks

What is the proposed timeline?

Commercial sterilizers will have 24 - 36 months to comply with the new requirements once established. It is critical for companies to plan now, so that they are ready to make potential changes.

Project manager updating calendar tasks

How can we help facilities in the transition to compliance?

The EMS-10 CEMS and MAX-iAQ instruments, using new OE-FTIR technology, can identify and quantify low-level EtO leaks with a detection limit of 1 ppb, meeting EPA proposed standards.

The systems provide a proven, turnkey solution that combines fast, sensitive, and reliable emissions analysis with the technical expertise needed for smooth installation, calibration, and regulatory support.

virtual diagram for understanding regulations and standards

Featured resources

Applying OE-FTIR for compliance with EtO emissions test methods

Applying OE-FTIR for Compliance with EtO Emissions Test Methods

Watch on-demand

Ethylene oxide continuous emissions monitoring by OE-FTIR

Ethylene oxide continuous emissions monitoring by OE-FTIR

Learn more

The advantages of Monitoring Ethylene Oxide with OE-FTIR

The advantages of monitoring ethylene oxide with OE-FTIR

Read article

Applying OE-FTIR for compliance with EtO emissions test methods

Webinar: Applying OE-FTIR for Compliance with Ethylene Oxide (EtO) Emissions Test Methods

Recently approved US EPA regulations address air quality and point source emissions from industries that use ethylene oxide (EtO). Companies must prepare to adopt new equipment and controls for monitoring EtO in compliance with updated NESHAP guidelines.

OE-FTIR spectroscopy stands out for its ability to analyze EtO emissions at concentrations as low as 1 ppb, even in challenging sample matrices off a stack. This webinar explains in depth how OE-FTIR technology can be used to provide high-quality data, even amid interferences and sample variability, and in turn help facilities that use EtO achieve compliance with new stricter standards.

Watch on demand

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