ETHYLENE OXIDE STERILIZER ALARM SYSTEMS

Revision Date: 5/00
Process Code: Navy/Marines: MD-01-01, MD-02-02; Air Force: MD01; Army: N/A
Usage: Navy: Medium; Marines: Medium; Army: Medium; Air Force: Medium
Compliance Impact: Low
Alternative for: Kem Medical Model 9000
Applicable EPCRA Targeted Constituents: Ethylene Oxide (CAS: 75-21-8), Dichlorodifluoromethane (CAS: 75-71-8)
Overview:

Ethylene Oxide (EtO) is a commonly used sterilizer in various industries including medical equipment suppliers, pharmaceuticals, museums, and hospitals. However, this chemical is a potent carcinogen that has been proven to cause cancer, reproductive mutations, and chromosomal alterations to exposed individuals. Therefore, EtO must be carefully monitored in order to prevent safety and health damage to personnel.

According to the Occupational Safety and Health Administration (OSHA) Standard 1910.1047 App.D, many techniques are currently employed to monitor and test for Ethylene Oxide (EtO): These techniques include charcoal tube sampling procedures, passive monitors, tedlar gas sampling bags, detector tubes, and direct reading instruments. This datasheet focuses only on the sterilizer alarm systems.

The sterilizer alarm system basically functions as a monitor to test the surrounding air for EtO levels. The system can be either portable, or wall mounted, depending on the user’s need. The alarm will monitor the EtO levels down to the specific ppm, and employ both visual and auditory alarms when the level has been exceeded. EtO detectors must be installed near the sterilizer in accordance with health and safety standards whenever EtO sterilizers are in use. The sterilizer must also be properly aerated after use.

These detectors are also sensitive to CFCs and HCFCs, and thus can give false alarms. CFCs and HCFCs are often used as part of the formulation for sterilizing agents. Because the sterilizing agents are oxidizers, such as EtO, and are usually very combustible, the CFCs/HCFCs serve as both fire suppressant and propellant. EtO is a suspected carcinogen, and CFCs and HCFCs are ODSs, so leak detection is a critical part of sterilization equipment maintenance.

Despite the fact that EtO is a suspected carcinogen, some 100% EtO (CFC and HCFC free) sterilizers are currently in use. EtO-free replacements have been produced (for example, hydrogen peroxide and ozone-based sterilizers). See the data sheet entitled ODS-Free Sterilization for more information on alternate sterilization equipment.
Compliance Benefit:

Use of ethylene oxide sterilizer alarm systems decreases the possibility that a facility would need to report releases of ethylene oxide or CFC-12 under 40 CFR 355 and EO 12856.

The compliance benefits listed here are only meant to be used as a general guideline and are not meant to be strictly interpreted. Actual compliance benefits will vary depending on the factors involved, e.g. the amount of workload involved.
Materials
Compatibility:


No materials compatibility issues were identified.
Safety and Health:

Consult your local Industrial Health specialist, your local health and safety personnel, and the appropriate MSDS prior to implementing any of these technologies.
Benefits:
  • Detects leakage of EtO and ODSs.
  • Reduces the possibility of large ODC and EtO releases.
  • Provides warning for personnel to avoid exposure.
Disadvantages:
  • Also Detects CFC and HCFC releases.


Economic Analysis:

There are many ethylene oxide detectors currently on the market. The EtOX I Area Monitor (AN 2600) by H.W. Andersen Products, Inc. provides accurate, single point monitoring of circulating air for EO levels. This system monitors ethylene oxide down to 1PPM. The Sierra Monitor Corporation utilizes the 4101-27 Ethylene Oxide Gas Sensor Module that provides a 4-20mA signal of Ethylene Oxide gas concentration within the range of 0-20ppm.

Kernco Instruments Co. Inc. offers both a wall mounted and portable gas detector unit. The wall-mounted unit provides a signal within the range of 0-10 ppm of ethylene oxide or 0-100 ppm, depending on the user’s needs. The portable unit also provides a signal within the range of 0-10 ppm or 0-100 ppm, also depending on the user’s needs. The following pricing information is based on Kernco Instruments’ website, which can be found at http://kerncoinstr.com

Product Price

ET6200P-10 Ethylene Oxide Detector (0-10 ppm) (portable)

$1,265.00

ET6200P–100 Ethylene Oxide Detector (0-100 ppm) (portable)

$1,265.00

ET6200-10 Ethylene Oxide Detector (0-10 ppm) (wall mounted)

$1,065.00

ET6200-100 Ethylene Oxide Detector (0-100 ppm) (wall mounted)

$1,065.00

ET6200R-10 Ethylene Oxide Detector with Remote Sensor (0-10 ppm) (wall mounted)

$1,025.00

ET6200R-100 Ethylene Oxide Detector with Remote Sensor (0-100 ppm)

$1,025.00


Approving Authority:

Approval is controlled locally and should be implemented only after engineering approval has been granted. Major claimant approval is not required.


NSN/MSDS:
Product NSN Unit Size Cost MSDS*
None Identified     $  

*There are multiple MSDSs for most NSNs.
The MSDS (if shown above) is only meant to serve as an example.


Points of Contact:

EPA:
Dr. Nancy Pate
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
Phone: (919) 541-5347
FAX: (919) 541-0242


Vendors:

Andersen Products, Inc.
Health Science Park
3202 Caroline Dr.
Haw River,  NC   27258-8710
Phone: (910) 376-3000 
or (800) 523-1276
FAX: (910) 376-8153
URL: http://www.anpro.com

Sierra Monitor Corporation
1991 Tarob Court
Milipitas,  CA   95035
Phone: (408) 262-6611 
or (800) 727-4377
FAX: (408) 262-9042
URL: http://www.sierramonitor.com

Kernco Instruments Co., Inc.
420 Kenazo Ave.
El Paso,  TX   79927-7339
Phone: (915) 852-3375 
or (800) 325-3875
FAX: (915) 852-4084
URL: http://www.kerncoinstr.com
Sources:

Dr. Nancy Pate, U.S. Environmental Protection Agency., April 1999.

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