Andersen Scientific

EO contract sterilization built on affordability, safety, and great customer service.

About Us

Andersen Scientific is so much more than a commercial sterilization facility. We prefer to consider ourselves as the research and development arm of your company. We work closely with your regulatory personnel to develop strategies in 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. We can assist in procuring the right sized package, develop a label, establish an expiration date, and validate the packaging and sterilization process.

Ten Fast Facts

  1. Most devices are sterilized the day they arrive and ship the following afternoon.
  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.
  8. We offer packaging, labelling, and small device assembly as well as sterilization.
  9. Our entire careers have revolved around solving sterilization problems others couldn’t.
  10. We use the patented 100% EO flexible bag sterilization method.

Services

Sterilization Validation

Sterilization Services

Packaging Validation

Packaging and Device Assembly

Feasibility Studies

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

"With time-sensitive products, having a turn-key sterilization system on site is a must. Andersen Scientific provides a cost and space effective solution for our radiation therapy device."

Robert Black

, Ph.D., President, Civatech Oncology, RTP, NC

"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

Customer Spotlight

Keystone Solutions Group


“Get it done” is a key mantra at Keystone Solutions Group. Flexibility, problem solving, and commitment to working overtime to “get it done” stood the company in good stead when COVID-19 began spreading in the US in the first quarter of 2020. The Michigan-based product development and medical device contract manufacturing company knew as the shelter-in-place mandates came out that Keystone could be a part of the solution.


“Healthcare organizations were foreseeing a gap in testing,” said David Furchak, Launch Architect at Keystone. A trusted economic development organization connected Keystone with a healthcare partner. As the requests for testing products rolled in, Keystone began producing swabs. “It was four weeks from the first request to the first set of swabs going out,” he said.


While Keystone’s regular business remained strong, the swab production required many at the company to take on a new job on top of their daily work. “We wanted to have a positive impact on the COVID pandemic,” Furchak said, which required employees to work overtime and on the weekends.


“That’s where Andersen Scientific was willing to jump in and understood how to get there,” he said. Andersen expedited the validation and packaging of Keystone’s swabs starting in March 2020. “The employees at Andersen have been good about figuring out the best path forward. Their collaboration and willingness to have conference calls at all hours is the key to success.”


Keystone has built its own success on collaboration and innovation. Founder Jim Metzger started the company as a consulting firm in his basement in 1997 to bring ideas to fruition. Concepts from a wide range of industries: automotive, consumer goods, aerospace… all were met with enthusiasm. “Jim is a visionary, and he turns that vision over to the management team,” Furchak said.


About 12 years ago, the focus narrowed to medical device manufacturing, and that was when Furchak joined the team. He helped the medical device part of the business find its footing—they are ISO 13485:2016 certified and FDA registered-—and they have served clients in wound care, diagnostic devices, imaging products, orthopedic packaging, airway and respiratory, and other areas. Since then, they have built relationships through the years that allow Keystone to take action when the partner has needs that match a Keystone skill set.


In only a few short months since the start of the pandemic, Keystone has worked to produce both swabs and PPE. The product development team initiated a disposable face shield project and transferred the assembly, sales and distribution to Goodwill in Michigan. In June, to continue its work with swabs, Keystone’s medical device manufacturing team began making sterile sample collection devices, or kits, that contain a sterilized swab in Tyvek packaged with a vial and cap in a pouch. Furchak noted that there is likely to be a need for testing at healthcare institutions for a while.


At Keystone, the pace hasn’t slowed down, and that’s the way Furchak likes it. “Our employees live by our values: ownership, collaborative, serve with humility, get it done, and fun,” he said. “Our values give us direction and an anchor. We know we’re all headed in the same direction.”

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 in 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 Assurance and Form Downloads

The Team

Daryl Woodman

Ben Watts

Zack Moss

Maria Zink

Magen Smith

Steve Brown

Daryl Woodman

General Manager

After over 20 years at Andersen Scientific, Inc., Daryl can still be found justifying his coffee habit by writing protocols every morning at 4:30 a.m. An inventor by nature, he developed the vessel Andersen uses to establish D values, and he continues to pioneer new techniques in sterilization. Each medical device is a new challenge, and he turns the details over in his mind not only between the hours of 8:30 a.m. and 5 p.m. but also while cooking meals from Epicurious, driving his WRX, or throwing toys to his German shepherd, Sushi. The owners of the company know that the way to Daryl’s heart is through his stomach, and whether it’s a five-course dinner in Barbados or a trip to the taco truck up the street, Daryl is on board.

Contact Us

Please get in contact with us if you have any questions.


Phone: (919) 388-5844


Email: info@ansci.us


Address:
1001 Aviation Parkway, Suite 600
Morrisville, NC
27560