Andersen Scientific, Inc.
Custom small-medium size EO contract sterilization built on affordability, safety, and great customer service.
Providing support to start-up and small/medium medical device companies. ISO 13485 Certified & Registered with the FDA (Est. No. 1064858)
Our Mission
We are committed to high standards of quality and customer service, primarily since we want to be known as the “go-to” professionals who are knowledgeable in all matters relating to Ethylene Oxide sterilization. We strive to deliver quality products efficiently, in a professional and flexible environment, on time, and at the right cost to our customers, while driving to become a world-class organization. Quality is not just another goal; it is our daily focus and the foundation for future growth.
Andersen Scientific is so much more than a commercial sterilization facility. We are focused on small to medium volume clients, and we prefer to consider ourselves as the research and development arm of your company. We work closely with your regulatory personnel to develop strategies for bringing your device to market, and if you don’t have a regulatory person, we can put you in contact with some of the industry’s best.
Zack Moss (left) - Validation Engineer at MD&M East, New York.
Environmentally friendly with near zero emissions
Andersen Scientific is quite possibly the most environmentally friendly Ethylene Oxide contract sterilization facility in the world.
Winner of the FDA’s Innovation Challenge 2 for reducing EO emissions.
Small Business Environmental Stewardship Award.
Awarded an EO permit exemption by the State of North Carolina for low EO emissions (emitting less EO than naturally occurring ambient EO levels).
Ten Fast Facts
1. 2448hr turnaround: Most devices are sterilized the day they arrive and ship after 24 hours aeration.
2. Lowest price: You only pay for the space you use, and not the entire chamber.
3. We perform extensive R&D for our clients, we are not just a commercial sterilizer.
4. Our top 3 managers have more than 75-combined years in the sterilization field.
5. We sit on the AAMI and ISO committees that create the standards used in the industry.
6. We offer an infinite number of cycles—whatever is necessary to get the job done.
7. We specialize in sterilizing small to medium lot sizes—that means as little as one device.
8. We offer turn-key sterilization and packaging validations, as well as routine sterilization.
9. Our entire careers have revolved around solving sterilization problems others couldn’t.
10. Our on-site EO emissions are near zero—low enough to qualify for an emissions exemption.
Available Services
Sterilization Services
Sterilization of medical devices or widgets using Ethylene Oxide for the healthcare industry, research institutes, government agencies, clinical studies, animal studies, and the pharmaceutical industry.
Validation Services
Fully validated sterilization processes complying with ISO 14937, single lot release studies for clinical trials, sealer, package, accelerated aging, and shipping and transport simulation studies.
Feasibility Studies
Perform a preliminary/feasibility study to demonstrate process suitability before the validation commences and get a jump start on biocompatibility, shelf-life, and shipping studies early on.
How our process is different
Unlike traditional Ethylene oxide (EO) sterilizers which involve rigid metal chambers and large external tanks of gas, the EO-FCT (Flexible Chamber Technology) method uses gas impermeable sterilization bags and unit dose 100% EO cartridges. By eliminating chamber dead space, EO-FCT employs only a tiny fraction of the EO used in other systems.
The EO-FCT method is extremely gentle on devices. By employing a longer, less harsh exposure cycle, we can avoid steam injection and heavy vacuums that are necessary for pallet chamber EO sterilization. Our standard EO-FCT exposure cycle can easily sterilize long narrow lumens-including those challenging lumens seen in modern-day endoscopes.
Quality and Regulatory
We are ISO 13485 certified and we are registered with the FDA as a contract sterilizer.
Visit our forms/download resources section to obtain a copy of our most recent ISO certificate.
Testimonials
The resources at Andersen Scientific have been an invaluable asset to start-up clients of mine. Andersen provided superior and personable expertise and guidance. Their sterilization services offered us flexibility and afford-ability that are not available with other contract sterilization providers. Andersen's attention to details, knowledge, costs, and quick turnaround times make them my only source to consider for sterilization needs.”
— Jon D. Speer, Creo Quality, LLC.
"We have always been very pleased with the service we receive from Andersen Scientific. They have provided excellent customer service, pricing, and support for the process. We looked at several vendors for our sterilization needs and we are glad we chose Andersen."
— Eric R. Hall, MHA | Director, Hepatic Research Registry CellzDirect | INVITROGEN Corporation
"I would like to take the opportunity to endorse the services of Andersen Scientific. Daryl Woodman and his team have given my company the most excellent customer service with quick turnaround on product and cost-effective solutions to our sterilization needs. Mr. Woodman has the experience and the commitment to his clients that is so rare in today’s business environment. I can highly recommend Andersen Scientific with confidence."
— Gaylene Fisch, RN, BSN
Meet our team
Daryl Woodman
Benjamin Watts
Zack Moss
Parker Hug
Conor Russell
Our canine support staff
Located in NC
RTP campus area
Our office is conveniently located in Research Triangle Park (RTP) only 3 miles from RDU airport.
Address: 1001 Aviation Parkway, Suite 600, Morrisville NC 27560
Telephone: (919) 388-5844