Selenium Medical

Medical Device Packaging and Surface Treatment Subcontractor

Selenium Medical is a specialist subcontractor of surface treatments and packaging solutions for medical devices. We can re-shape sterile packaging to become more innovative and practical.

From standards to custom packaging, we offer different solutions in cleanroom 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.

Surface and packaging sterilisation for medical devices

Selenium Medical is professional and 100% dedicated to medical devices, and focused on optimum customer satisfaction. Our personnel have experience and expertise in the medical industry.

One of Selenium Medical's priorities is to share its expertise to help customers choose the most suitable solution and provide products of supreme reliability. Selenium Medical is also certified ISO 13485, ISO 9001, and complies with US Food and Drug Administration (FDA) regulations.

Compact packaging systems for medical implants

SoTube and SoSafe are two 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, up to the point of surgery.

These new packaging concepts have been voted as the best innovative solutions and best alternatives to double-pouches and double-blisters for AmeriStar 2014, Medical Design Excellence Gold Award 2014, IoPP Best of Show 2014, and Medtec France Bronze Innovation Award.

Space-saving and waste-reducing alternatives to conventional implant packages, the SoTube and SoSafe systems, with a shorter or extra long stopper consists of a transparent tube nested inside another, providing 360° visibility of the implant. It can be configured in various ways.

Both systems come in various sizes, with a colour coding system on the stopper, relating to implant size, length and other information. The tubes make it easy for operating theatre assistants to identify the appropriate implant and open the package, validated to maintain sterility through five years of shelf life following gamma sterilisation.

Blister and custom procedure trays (CPT) for medical packaging

Selenium Medical designs, develops and thermoforms in cleanroom ISO class 7 all shapes of blister packs, from the smallest to the largest, whether sealed or custom procedure trays (CPT). These comply with 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 blister packs.

We can provide you with a broad range of thermoformed materials depending on the sterilization method used, including polyethylene terephthalate (PETG) amorphous PET (APET) and polycarbonate (PC).

Sterile pouches for medical use

Selenium Medical can respond to your requirements, due to an extensive range of sterile packaging in pouches whether it is peelable, breakable, for autoclave, gamma or ethylene oxide (ETO) and vacuum.

Available in different materials such as Tyvek and OPAPE, we customise pouches that are compatible and adapted to sterilisation by irradiation, steam or ethylene oxide.

Validated according to NF EN ISO 11607 and NF EN 868 standards for the packaging of sterile medical devices, the pouches are subjected to various tests such as impact-resistance, sealing and compatibility compliance.

High-performance packaging for surgical equipment

Our outer packaging in cardboard, plastic or aluminum ensures optimum presentation of your products in the operating theatre. We place all our resources and expertise at your disposal to help define your project with appropriate visuals. Together, we can develop new, high-performance outer packaging, which is innovative and personalised.

From custom boxes such as SoStore and ComboBox to standard boxes, we offer opportunities for product presentation.

Medical surface treatments

All of our surface treatment processes are developed and validated by our expert team, according to installation qualification (IQ) operation qualification (OQ) and performance qualification (PQ) processes. Our accreditations include product performance qualification (PPQ), demonstrating the full control and preservation of your medical devices' biocompatibility during chemical treatments.

Our surface treatment services include:

  • Three types of anodisation: type I and III for colored anodisation, with or without size variation and type II for dark anodizing (grey) and improved mechanical properties
  • Passivation of stainless steel and titanium medical devices with ecological processes using citric acid
  • Electropolishing for shinier and more resistant stainless steels against corrosion
  • High-precision laser marking for tamper-proof traceability
  • Cleaning disinfection

Contact Details

Selenium Medical
Selenium Medical 40 rue Chef de Baie
Zi Chef de Baie
17000 La Rochelle
France
+33 (0)5 46 44 40 82
+33 (0)5 46 31 62 71
contact@selenium-medical.com
www.selenium-medical.com

Available White Papers

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Double Tubes for Sterile Packaging of Implants 27 July 2015 SoTube and SoSafe have double packaging for sterile implants, an optimised implant display and various configurations.

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SoTube and SoSafe User Guide 24 July 2015 The following criteria of an implant will define the tube and holder type.

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Surface Treatment 17 July 2015 Selenium implements its own surface treatment processes and equipment.

Company Videos