Norman Noble logo
Norman Noble logo

Passivation & Cleaning

AUTOMATED AND VALIDATED.

Norman Noble has completed a variety of validations for implant grade materials that customers can leverage.

Norman Noble Cleaning Passivation Lines

improve productivity, product quality, product consistency, operational safety and reduction of environmental waste

As an industry leader in the contract manufacturing of medical devices and nitinol implants, Norman Noble offers the most advanced technologies to customers, including fully automated passivation and fully automated & validated final cleaning processes.

Our new Elma cleaning line and shareable validation reports help simplify our customers’ submission and compliance with Regulation (EU) 2017/745 of the European Parliament and are designed to support meeting the requirements of Annex II.

improve productivity, product quality, product consistency, operational safety and reduction of environmental waste

As an industry leader in the contract manufacturing of medical devices and nitinol implants, Norman Noble offers the most advanced technologies to customers, including fully automated passivation and fully automated & validated final cleaning processes.

Our new Elma cleaning line and shareable validation reports help simplify our customers’ submission and compliance with Regulation (EU) 2017/745 of the European Parliament and are designed to support meeting the requirements of Annex II.

FACTS AT A GLANCE

  • Cleaning 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
  • Elma cleaning line meets EU MDR requirements (EU) 2017/745
Norman Noble Orthopedic Implant Prototypes

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.

WHAT WE MAKE

  • Vascular Stent Implants
  • Bioresorbable Scaffolds
  • Transcatheter Heart Valve Implants and Frames
  • Neurovascular Clot Retrieval Devices
  • Neurovascular Stentrievers
  • Flow Diverters
  • Embolic Filters Arterial Closure Implants
  • Atrial Fibrillation Devices
  • Vena Cava Filter Implants
  • Renal Denervation Devices
  • Spinal Implants and Devices
  • Exremity Screw and Plate Implant and Devices
  • Ligament Repair Anchors and Devices

MATERIALS WE USE

  • Cobalt Chrome
  • Molybdenum
  • Nitinol
  • Tantalum
  • Platinum
  • MP35N
  • Kovar
  • Stainless Steel Alloys
  • Titanium
  • Tungsten
  • Stainless
  • Carbon Steel
  • Tool Steel
  • High Nickel Alloys
  • Aluminum
  • Co-Cr

PRODUCTION & CAPACITY

  • Over 40 systems, including automated passivation lines, automated cleaning lines, automated dryers, microburnishing systems, and tumbling systems
Norman Noble Orthopedic Implant Prototypes