Root Cause Analysis

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CPG's experience in polymer analysis has allowed us to assist clients in root cause analysis on a projects ranging from initial product development to manufacturing. We design experiments to isolate process and material variables, perform Design of Experiment programs, and provide clients with alternatives to the process or materials causing the issues.

  • Radiation response of materials
  • Environmental crazing
  • Blends compatibility
  • Molding defects
  • Additives
  • Packaging issues

Case Study 1

In late 2000, Sulzer Orthopedics noticed that a group of metallic acetabular shells with porous backing for osseointegration were failing at high rates. Cambridge Polymer Group was hired, along with other consultants, to investigate the cause of the failure. Scientists at CPG designed new testing protocols and determined that the failure was not due to a manufacturing residue left on the compound, as was previously surmised, but rather was the result in the change of a nitric acid passivation process.

"Cambridge Polymer Group was very helpful after we had to recall an acetabular shell in December of 2000 by analyzing the types and amounts of the oily residue. CPG tested hundreds of parts within the first few weeks after the recall, even during the holiday season of 2000/2001. The work of CPG was much appreciated, and helped us to get parts back on the shelf quickly."

Dr. Urs Wyss
Vice President of Research
Sulver Orthopedics, Ltd.

Case Study 2

A manufacturer of balloon catheters noticed that specific lots were fracturing in clinical use. CPG scientists determined that the catheters, which contained a polymer susceptible to radiation-induced chemistry, were partially oxidizing as a result of the catheters being sterilized with ionizing radiation. CPG was able to help the manufacturer change their process conditions to avoid this problem.

Case Study 3

A client wanted a method for cleaning the hulls of boats while they were at anchor. CPG scientists developed a flowable, environmentally-compatible material containing a cleaning agent that could be applied under water and would adhere to the boat, would clean away crustaceans and buildup, and would then be easily sheared off once the boat was in motion.

Case Study 4

A medical device manufacturer was fabricating syringes, and noticed microcrack formation in some of the fabricated syringes. CPG developed a multi-variable study which identifed that the combined conditions of unreacted monomer from an adhesive coupled with accelerated aging conditions lead to environmental crazing in the samples.