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Double-sterile barrier packaging in tube format wins multiple awards

January 5, 2016

3 Min Read
Double-sterile barrier packaging in tube format wins multiple awards

Pharmaceutical & Medical Packaging News staff

Two tube packaging systems for medical implants have been recognized with multiple awards. The systems are unique because medical implants are usually placed in pouches or thermoformed packages, says Olivier Richart, CEO and President at Selenium Medical, which manufactures the SoTube/SoSafe systems.

The tubes won a Medical Design Excellence Award (MDEA) gold award for their innovative design, and they also won Best of Show along with an award in the Medical Device category in the 2014 AmeriStar Awards program organized by the Institute of Packaging Professionals (IoPP). Both ceremonies were held in New York City in June in conjunction with the MD&M East/EastPack/Pharmapack North America shows.

The products also offer an extra layer of safety because they come in double-sterile barrier packages, while most packaging is in single-barrier form, says Richart. Richart says that the systems are the first to provide double-sterile barrier packaging in a tube format, and also the first to package an implant in a tube.

“The key point of our product is that it has a double-sterile barrier,” says Richart.”We are ahead of most types of packaging--80% of packaging are single barriers, but there are more and more requests to increase the safety and aseptic transfer to the patient. That is why double-sterile barriers are more and more requested.”

The two products are similar in design, but with a few key differences. SoTube is primarily designed for spinal surgery, and SoSafe is especially suitable for trauma cases. SoSafe enables a nurse or surgeon to transfer the implant to the patient without touching it due to the company’s NoTouch technology. Both come in the sizes M, L, XL, and XXL. The company also plans to develop an S-sized package for small implants.

Richart says that the company created the product after watching nurses and doctors work in the OR. “We spent a lot of time in the operating theater and watched how the surgeon or nurse worked with sterile barrier packaging pouches,” says Richart. “It is sometimes weak because it can be pin-holed due to the sharp edge of an implant, and blister packaging is quite bulky and difficult to open. We thought that there is a need to improve the usability of packaging at the hospital’s operating theater.”

At a time where medical device companies are focused on cost-cutting measures and sustainability, a tube-shaped package is also appealing because it can reduce packaging size and waste. Because of the product’s uniqueness, the development process was not without its hurdles.

“There were huge difficulties,” says Richart. “We had material challenges because we wanted materials that could be injected and that were sterile, we wanted a high transparency material which remained transparent after sterilization, we wanted to have a product for a 5-year shelf life. We had some technical challenges to demonstrate and to achieve in a proper manner sterile barriers. We had some challenges in achieving the sealing because the sealing is achieved by pulling. The biggest challenge was to do all that in compliance with ISO 11607.”

The effort paid off this year, with Selenium Medical winning not only the MDEA and AmeriStar awards but also the Best of the Show of Eastpack in all categories, the MEDTEC France Innovation Bronze Awards, and the Implants 2014 Best Innovation of the Year.

“It’s international and independent recognition of our commitment to develop a new solution for the packaging of implants,” says Richart. “For us it’s a key to success. Without these awards, all the work we have achieved and all the challenges we have faced and solved would not have been recognized. It’s really a door opening.”

Click here to watch a video on SoTube/SoSafe.

By Camilla Andersson
Freelance Journalist

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