Medical Device Assembly, Packaging and Sterilization
Producing individual components through to finished devices
Single components such as silicone punctal plugs and small joint implants function as complete medical devices. More often though, a fabricated component is only one part of a larger and more complex device.
Trelleborg Sealing Solutions provides the medical device industry with a complete suite of post-fabrication services including:
- Extensive range of secondary operations
- Complete device assembly
- Expert packaging
- In-house and contract sterilization
- Warehousing and distribution services
Secondary OperationsAt Trelleborg Sealing Solutions, we provide added value to our customers by offering an extensive range of secondary operations including post curing, printing, die cutting, drilling, tipping, bonding, slitting, trimming, coiling, and functional testing.
Complete Medical Device Assembly ServicesOur device assembly expertise is as varied as the requirements of our customers; projects have ranged from routine sub-assemblies involving silicone, metal, plastic, and ceramic components to the assembly of shunts formed from porcine-derived polymer to the complete manufacture of fully functional neurological implants. Here are two examples of our assembly capabilities:
- Implantable neurological sensing device: Silicone components including die-cut reinforced sheeting, a molded electrode positioner and tubing were assembled into an eight electrode array. The assembly process included fixtured positioning, bonding, laser welding, micro-crimping, laser stripping, and custom tray packaging. Pass-fail functional testing evaluated both electrical resistance and capacitance.
- Novel mammary implant: The bill of materials involves 38 parts including dipped shells, precision molded valve components and extruded tubing. The process batch record fully details 58 discrete assembly steps beginning with line clearance and ending with product release as sterile finished goods. Serialized inner tray and shelf box labels are printed and controlled on-site. Each implant is laser etched with corresponding serial identification.
Packaging and SterilizationAt Trelleborg Sealing Solutions, our engineers collaborate with customers to design packaging solutions that are appropriate for various sterilization methods, device storage, and intended use. We provide pre-validated pouching and tray sealing services as well as work with trusted outside vendors to develop custom product packaging.
We were the first silicone contract manufacturer to offer in-house dry heat sterilization, thereby complementing services of outside partnering vendors who provide sterilization via gamma, e-beam, and ethylene oxide technologies.