Did you know that Dr. Crystal Morrison’s article, “Creating Vision Across the Polymer Lifecycle,” was recently featured in Medical Plastics News? In case you missed it, here is a summary from Dr. Morrison and more information on how to access the full article.
In my experience as a material scientist, I’ve noticed that polymers and plastics are often considered the “least critical” material in a system. Material selection boils down to “whatever will work.” This philosophy might pass in limited circumstances, but it is certain to fail when dealing with components for highly regulated spaces such as the life sciences industry. The challenge is to develop a proactive program that anticipates requirements and end user needs in order to create vision across the entire polymer lifecycle.
The following strategy can help you to:
- Establish project schedules
- Address materials selection and testing needs
- Meet regulatory requirements
- Minimizing potential liability
- Ensure component success
The first step in creating this vision is to define and map the steps in your unique process. Below is a general example of what a process might look like from raw material to the final component.
After defining the steps (i.e., Materials Acceptance, Molding, Post Treatment), zero in on the component. Identify factors for the final component that include all relevant requirements, regulations, and specifications. Ask yourself “Who are the stakeholders?” and then engage those individuals. A comprehensive list of overall requirements for the component should include Regulatory and Operational Requirements, Expectations, Form, Fit, and Function.
Once you have determined critical factors for the final component go back to your process and identify these same factors in each step or stage. Build the bigger picture.
Now, consider the following questions for each step or stage in the process:
- What specifications exist or are needed to demonstrate requirements?
- What testing has been done in the past, if any? Should more testing be done and at what level?
- Is modeling being used to predict material properties? What data are used in the models?
- Are the data collected under conditions that mimic actual use?
You may begin to notice that certain testing, modeling, or specifications don’t necessarily align with your overall requirements. For example, the plastic component must be stable to rad (radiation absorbed dose) sterilization. However, no characterization of the raw material demonstrates the presence of rad stable functional groups. Alternatively, perhaps the final component must have no metal contamination for x-ray transparency. Was metal content screened in the raw materials and verified in materials acceptance?
When asking these questions, you will start to see gaps that need to be addressed. You and your team members will also have a much better understanding of the entire lifecycle and a better appreciation for how small adjustments can make a big impact on the performance of the final component. This simple strategy helps establish all requirements to aid product design as well as Engineering Evaluations, Troubleshooting, Process Improvement, Failure Analysis, and Product Liability Risk Assessment.
To incorporate the lifecycle strategy into your organization’s processes, follow the simple 5-step approach listed below. While based on the polymer lifecycle, this approach is broadly applicable across the life sciences and can be tailored to the specific needs of your industry.
- Map the Material Lifecycle
- Define Component Requirements
- Define Stage Requirements
- Analyze Requirements vs. Outcome at Each Stage
- Align Analysis at Each Stage with Requirements Across Lifecycle
If you would like to see these concepts applied to a real case study, I encourage you to read my full article in Medical Plastics News. In the article, I explain how my team and I were able to conduct a failure analysis study on a cell culture container using the lifecycle concept. To read the full article, visit Medical Plastics News or download the PDF here.