Selenium Medical offers full services in surface treatment and packaging solutions, 100% dedicated to medical devices.
Our goal is to contribute to our customers' success with more innovative and practical sterile packaging. From standards to custom packaging, we offer different solutions in clean room ISO class 7 and 5. This includes double-pouches, double-blisters and our rewarded double-tube packaging, SoTube® and SoSafe®.
The company supports projects concerning medical surface treatments, covering all stages relating to product surface quality. Anodising, passivation, electropolishing, laser marking and cleaning are some of our qualified services.
Selenium Medical is professional and 100% dedicated to medical devices, and focused on optimum customer satisfaction. Our personnel have backgrounds and expertise in the medical industry.
One of Selenium Medical's priorities is to share its medical expertise to help customers choose the most suitable solution and provide products of supreme reliability. Selenium Medical is also certified ISO 13485 and ISO 9001, and complies with US Food and Drug Administration (FDA) regulations.
SoTube and SoSafe are two double-sterile barrier compact packaging systems for longitudinally shaped medical implants. They have been designed to optimise preservation, presentation and safety of the implantable device with a pioneering 100% no touch approach right up to the point of surgery.
These new packaging concepts have been elected as best innovative solutions and best alternatives to double-pouches and double-blisters in 2014 (AmeriStar 2014, Medical Design Excellence Gold Award 2014, IoPP Best of Show 2014, Medtec France Bronze Innovation Award...) and 2015 (WorldStar Packaging Award).
Space-saving and waste-reducing alternatives to conventional implant packages, the SoTube and SoSafe systems, with a shorter or extra long stopper, respectively, consist of one transparent tube nested inside another, provide 360° visibility of the implant and can be configured in various ways.
Both systems come in a range of sizes, with a colour coding system on the stopper that relates to implant size, length and other information. The tubes are designed to make it easy for operating-theatre assistants to identify the appropriate implant and open the package, which is validated to maintain sterility through five years of shelf life following gamma sterilisation.
Selenium Medical designs, develops and thermoforms in clean room ISO class 7 all shapes of blister packs, from the smallest to the largest, whether sealed or custom procedure trays (CPT), complying with the NF EN ISO 11607 and NF EN 868 packaging standards for sterile medical devices.
Our principal expertise resides in our capacity to help each customer express their needs and define their projects. Your specifications and constraints will be addressed by our teams' extensive experience of the medical industry, which includes designing, studying, testing and producing your blister packs.
We can provide you with a broad range of thermoformed materials depending on the sterilisation method used, including polyethylene terephthalate (PETG) amorphous PET (APET) and polycarbonate (PC).
Selenium Medical can respond to each of your requirements thanks to an extensive range of sterile packaging in pouches. Peelable or breakable, for autoclave, gamma or ethylene oxide (ETO), vacuum or otherwise, we can answer to each of your requirements.
Available in different materials such as Tyvek and OPAPE, we use pouches tailored to your needs, which are compatible and adapted to sterilisation by irradiation, steam or ethylene oxide.
Validated according to NF EN ISO 11607 and NF EN 868 standards in force for the packaging of sterile medical devices, the pouches we use are the subject of various tests including impact resistance, sealing and compatibility compliance.
Our outer packaging in cardboard, plastic or aluminum can ensure optimum presentation of your products in the operating theatre. We place all of our resources and expertise at your disposal to help you define your project with appropriate visuals. Together, we can develop new, high-performance outer packaging that is innovative and personalized.
From custom gathering boxes such as SoStore™ or ComboBox to standard boxes, we can offer you large opportunities for your product presentation.
All of our surface treatment processes are developed and validated by our expert team as per IQ, OQ and PQ processes. Our qualifications include PPQs (product performance qualification), demonstrating the full control and preservation of your medical devices' biocompatibility during our chemical treatments.
Our surface treatment services include:
StarSurf enhances bone attachment and stimulates osseointegration by creating macro, micro and nano structures on the surface of the implant.
Our contract packaging services include the cleaning, packaging, labelling, sleeving and sterilisation outsourcing of medical devices.
This innovative and 100% no touch packaging, called SoTube and SoSafe, ensures the sterility of your medical devices for five years.
