Kensey Nash

Biomaterials

Transforming Biomaterials Into Clinical Reality

 

Contract Assembly and Packaging

Kensey Nash Corporation was incorporated in 1984 and is located in Exton, Pennsylvania.

  • Approximately 300 Employees

  • 202,000 sq ft Facility built in 2006 with integrated Class 100,000 / ISO Class 8 Clean Rooms

  • ISO:13485 and FDA Compliant

For more than 13 years, Kensey Nash has been providing customers with fully packaged and sterilized products. Products we manufacture are used worldwide in orthopedic, spinal and cardiovascular applications. Annually, we provide approximately 4.5 million medical components.

 

We have the following staff to support your projects:

  • A Production Staff of approximately 90 Technicians to Assemble,
    Test, Inspect and Package products.

  • A complete Manufacturing Engineering Staff who are experienced
    in Tooling, Automation, Project Management, Contract Packaging
    and Contract Assembly.

  • A dedicated Regulatory staff ensuring FDA and ISO compliance.

  • Quality Assurance personnel who perform incoming, in-process
    and final inspection to assure full specification compliance on
    every lot of material received and shipped.

We have performed numerous US and EU Marketing submissions, sterilization validations, process validations, test method validations, ship/shake and packaging validations.

 

With sterilization sources under contract for Gamma, ETO and E-Beam sterilization, we can meet the needs of your sterilization requests.

 

We can design custom machinery to meet any assembly or packaging need.

 

Our Standard Packaging Machinery includes:

  • Automated Pouch Machines with integrated, automated Label Applicator

  • Pouch Sealing Machines for large or low volume pouches (requires no tooling)

  • Rotary Tray Sealing Machines

  • Large Tray Sealing Machines

  • Automated Shrink Wrap Machine

  • Automated Label Applicators

  • Thermal transfer Label Printers for black and color printing

  • Automated Vision Inspection Conveyor

 

 

 

For more information or to inquire about a Contract Assembly or Packaging Project please call 484-713-2100 or Click here to request info about Contract Assembly and Packaging.