As an industry leader in the contract manufacturing of medical implants and devices, Norman Noble offers the most advanced technologies to customers, including fully automated and validated passivation and final cleaning processes.
Norman Noble’s cleaning validation documentation: Strategy, IQ, OQ and PQ, have been completed in a format that can be shared with customers and includes a matrix of small to large part sizes, shapes and geometric complexities produced from many medical implant material grades. This allows customers to review the validation process, documentation and test results in detail. Norman Noble’s customers can compare this information to their current or proposed cleanliness specifications. In many cases this gap analysis will show the Norman Noble cleaning validation process fully satisfies customer requirements for specification and regulatory compliance.
Norman Noble’s advanced systems improve productivity, product quality, product consistency, operational safety and reduction of environmental waste. For more information, download our Passivation & Cleaning white paper.
Facts at a Glance:
- Validated per ISO 13485:2016
- Automated cleaning and automated passivation
- Residual materials, particulate size analysis, cytotoxicity, total organic carbon, endotoxins, corrosion resistance
- Cleaning validation according to ASTM F3127
Materials and Applications
Vascular Stent Implants:
AAA (Abdominal Aortic Aneurysm)
BTK (Below The Knee)
Transcatheter Heart Valve Implants and Frames:
Left Atrial Appendage Closure
Neurovascualr Clot Retrieval Devices
Embolic Filters Arterial Closure Implants
Atrial Fibrillation Devices
Vena Cava Filter Implants
Renal Denervation Devices
Spinal Implants and Devices
Extremity Screw and Plate Implants and Devices
Ligament Repair Anchors and Devices
Stainless Steel Alloys
High Nickel Alloys