Polymers and Plastics Series: Deformulation Strategies

02 Apr 2019

Using Reverse Engineering for Insights and Answers

Raw material and finished product manufacturers use reverse engineering to guide many decisions. For polymers, deformulation can identify individual chemical components, morphology, molecular weight and thermal responses to aid in such decisions.

The need for deformulation might appear in several situations, each with its own considerations and processes.  They include:

• Bringing manufacturing in-house. If a current supplier leaves the market or a manufacturer simply seeks to reduce costs, deformulation provides valuable insights to bring production in-house.  For this purpose, experts will need review of available literature, conduct necessary screenings and perform in-depth analysis based on the product's form.
• Identifying an alternative supplier. Used if a supplier leaves the market or to reduce costs with another supplier. In this case the manufacturer should review all and consider partnering with alternative suppliers for testing. As a result, testing can focus on comparing alternatives based on chemistry and mechanical properties.
• Performing failure analysis. If a current material is no longer behaving in a similar manner, deformulation can play an important role in determining why.  Behavior specifics and sources of failure must be considered, as should an understanding of the specifics around the failure. Identifying the failure and ruling out design flaws or external influences and examination through analyses are also important steps.
• Evaluating patent infringement and defining the space for IP development. Deformulation can be valuable in determining if a product or chemical infringes upon a patent. It can be used both to investigate competitors for infringing on a patent or to determine if a new product would violate an existing patent. When conducting deformulation for IP purposes, it is important to do your homework and ensure that analysis is driven by claims.
• Establishing data for regulatory needs. Regulations such as the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), California's Proposition 65 or requirements from bodies like the Food and Drug Administration (FDA) may require chemical identification via reverse engineering. It is important to determine applicable regulatory requirements and which quality system needs to be in place for the testing facility. Then, develop a test plan, including any methods development and validation needs.
• Determining the safety in-use during manufacturing or utilization of the material. Used when translating a product to a new application or new process, deformulation can provide insights on the potential for worker and environmental exposure, which in turn feeds toxicological assessment of the findings. This use generally requires three steps: designing a scenario for the evaluation; testing to identify chemical species and their levels as a function of the surface area, size or weight of product; and conducting a toxicological evaluation to render a safety assessment.

Because the testing requirements vary based on the end goal, it is important to understand what the end goal is before proceeding with a deformulation project. In addition to end goal, it is important to understand the type of data each process needs and generates.  Deformulation delivers a set of chemical fingerprints and mechanical properties; it does not typically provide a list of commercially named products and their concentrations. Findings need to be interpreted properly to recognize chemical fingerprints and rule out product grades or suppliers. There will also be structural nuances that need to be probed, such as surface treatment and multi-layer structure that require an even more advanced suite of analytical methods to characterize.

Reverse engineering is a key tool in defending products, building improved products and meeting regulatory requirements. Working with a trusted partner and developing a detailed, appropriate test plan are critical in conducting deformulation on plastics and polymers.  Learn more about deformulation strategies in our webinar recording.