Sterilization made simple.
Here are some of the most common questions we are asked, here at Andersen. Click on the question to see the answer. If you have a question you don’t see listed here, please contact us.
Is ethylene oxide going to be banned? Has it already been banned in certain areas?
No. EO is not being banned, nor is it banned in certain areas. EO continues to be broadly used for the processing of food products, cosmetics, manufacturing and medical devices. It is a critical sterilant manufacturers widely use to keep medical devices, implants, scopes, etc… safe. In fact, during the 2015 carbapenem-resistant Enterobacteriaceae (CRE) outbreak, the FDA recommended four supplemental reprocessing measures, which included EO sterilization as the most effective in assuring the complete inactivation of highly resistant organisms.
Bacteria are changing all the time and becoming resistant to antibiotics. Recent outbreaks of MDRO’s have only been eradicated when gas sterilization was brought into the picture. EO sterilization will change to reduce emissions but the great thing about our company is we already use the smallest amount of EO on the market and Andersen offers abatement options for all its sterilizers.
Here’s the The Ethylene Oxide Sterilization Association‘s statement on the topic.
Is ethylene oxide more toxic than other sterilization chemicals?
NO, this is a common misconception. When comparing Time Weighted Averages (TWA) the comparative toxicities of EO to other chemicals, this chart clearly shows that higher allowable levels for EO, proving it’s not any more toxic than other chemicals used in the workplace.
We recommend that you proceed with caution with all chemicals you use in any situation. Using simple precautions can alleviate problems from happening. Knowing the safety guidelines for that item is extremely important.
We offer free training for the life of your Anprolene or EOGas sterilizer that will cover the safety features and operation of the machine. Call us at 800.523.1276 and ask for your area representative.
|Ethylene Oxide||Hydrogen Peroxide||Peracetic Acid||Glutaraldehyde|
|OSHA 8hr/15min PEL: Permissible Exposure Limits||1 ppm / 5 ppm||1 ppm / –||– / –||– / –|
|ACGIH 8hr/15min TLV: Threshold Limit Values||1 ppm / –||1 ppm / –||– / 0.4 ppm||0.05 ppm / –|
|NIOSH 8hr/10min REL: Recommended Exposure Limit||<0.1 ppm / 5 ppm||1 ppm / –||– / –||0.2 ppm / –|
|NIOSH IDLH: Immediately Dangerous to Life or Health||800 ppm||75 ppm||0.55 ppm |
|– / –|
|HSE 8hr/15min WEL: Workplace Exposure Limits||1 ppm / –||1 ppm / 2 ppm||– / –||0.05 ppm / 0.05 ppm|
|Cancer Status||IARC: Carcinogenic to Humans|
ACGIH: Suspected Human Carcinogen
|IARC: Not Classifiable as to Carcinogenicity in Humans|
ACGIH: Confirmed Animal Carcinogen with Unknown Relevance to Humans
|ACGIH: Not Classifiable as a Human Carcinogen||– / –|
|Odor Threshold||400 to 700 ppm||Almost no odor||50 ppm||0.04 ppm|
|CAMEO Datasheet||Ethylene Oxide||Hydrogen Peroxide||Peracetic Acid||Glutaraldehyde|
|Downsides||Cycle times (Andersen: 3.5 – 26 hours including standard aeration)||Acquisition, labor, operating and service costs, reliability issues, struggles to sterilize long lumens, pulls a deep vacuum that can damage delicate items, corrosive||Immersible instruments only, makes plastic brittle, corrodes metal, can only process one scope or a small number of instruments per cycle1|
|NOT compatible with||Food, drugs or liquids||Cloth, liquids, paper, powders, anodized aluminum and anything containing cellulose||Aluminium, carbon steel, some cross-linked|
polyethylene and metal alloys containing copper
More about EO comparative toxicity.
Does an ethylene oxide Sterilizer require special installation?
Anprolene and EOGas sterilizers only require a dedicated exhaust and 110/220V electrical for installation, making it the simplest installation on the market. Our sterilizers have optional abatement equipment. When used in line with our systems, the abator renders emissions 99.9% free of EO. Some other EO sterilizers require separate aeration chambers, holding cells, air pressure tanks, water sources and vacuum. Andersen Sterilizers’ systems are unique to the market and never had those additional requirements.
How is ethylene oxide regulated for worker safety?
OSHA regulations require facilities to closely monitor worker exposure to EO. These regulations restrict permissible time weighted average (TWA) EO exposure of workers to 1 part per million (ppm) for an 8-hour workday and 5 ppm for any 15-minute period. In facilities where worker exposure may exceed these levels, employers must institute numerous measures to meet OSHA regulations. A facility is excused from these measures if it can document that worker exposure levels do not exceed those mentioned below under Initial Monitoring Results.
This document outlines permissible EO exposure limits and monitoring strategies.
Can ethylene oxide be used to sterilize liquids, food or drugs?
Certain food components, including vitamins and amino acids, are chemically altered by EO. Other limitations include all liquid substances and materials which are completely sealed in glass vials or in non-vented devices.
Because EO is gaseous during sterilization, it cannot penetrate through liquids to sterilize them. It also cannot penetrate sealed glass, metal, or certain plastic (nylon, mylar, etc) containers.
Contact an Andersen gas sterilization expert for more details to see how EO interacts with your product.
Keep in mind, EO is compatible delicate instruments, electronics, drills, fiber optics, hand pieces, cameras and batteries. As well as plastic, fabric, cellulose and rubber items. EO will penetrate through mated and threaded metal surfaces and certain plastic containers (including Tyvek).
Do any U.S. states currently require permits for use of EO sterilizers?
Yes, there are some counties and states that require both permits and abatement for EO sterilization. But don’t worry – we’ve got you covered. The Andersen team has a long working history with both federal and local regulatory agencies and will serve as your resource to prepare and submit any permits required. We are your gas sterilization experts. Contact us with any questions regarding EO regulations in your area.
What is the useful life of an Andersen sterilizer?
The useful life of all Andersen sterilizers is 10 years from the date of manufacture. The Lot/Series Number on the back of the sterilizer indicates the year the sterilizer was manufactured. For example, the first two numbers of the Lot/Series Number 210659 indicate the sterilizer was manufacturers in the year 2021. Useful life refers to the time-period during which Andersen Sterilizers will maintain a spare parts inventory and provide service to repair the sterilizer.
Fun fact: the useful life for most medical devices is typically set at seven years.
Is operator training free?
With the purchase of your Andersen sterilizer, you and your staff receive free operator training for the life of the machine. The Andersen Key Operator Certification Program is highly recommended for all operators at your facility before hey use the sterilizer for the first time.
We can train individual staff as they come on-board or give a refresher to your whole staff.
Steps to get certified:
- Contact your Andersen Account Manager to request a copy of the Key Operator Study Guide for your sterilizer.
- Contact your Andersen Account Manager to schedule your 20-minute test.
- Key Operator Certificate provided upon completion. Certification is transferable.
- FREE operator training for the life of the sterilizer!
- Schedule your training today!
What do I do in case of emergency?
No matter the problem, our support team is available 24/7, 365 days a year for you.
Monday – Friday, 8:30am – 5pm EST, call 800.523.1276
Any Other Time (Emergency After Hours), call 800.255.3924
Do Andersen sterilizers come with a warranty?
Yes, Andersen Sterilizers warrants its gas sterilizers with a one-year limited warranty. Please reach out to Customer Service for a copy of our One-Year Limited Warranty for full terms and conditions: 800.523.1276.
Can you give me an idea of shipping times and costs?
All of our products are shipped from our headquarters in North Carolina. Please keep that in mind when placing orders to ensure you receive your product on time. For those of you that push the envelope, we do offer priority shipping options. All sterilizers are shipping via freight to ensure a damage-free delivery. Freight charges are available through customer service or your Account Manager.
Does Andersen take returns?
Yes, we accept returns that meet our return policy. Below is not our full policy but hits the highlights for your convenience.
All returns MUST have prior approval. Contact customer service at 800.523.1276.
Please report shipping errors or damage within 2 business days.
Products must be in original packaging. Products found to be defective upon receipt will receive full credit and refund of shipping costs. Products in resaleable condition returned within 30 days of invoice date will receive 90% of net costs, after 30 days 80%. If products are resaleable but require reprocessing or repackaging and are returned within 90 days, 50% of net cost. After 90 days, no credit.
No credit for products with more than half of its shelf life expired, if it is unsuitable for resale or if returned with no prior approval. Please contact customer service to ask how to proceed with a return, or for our full return policy.