Pharma Bottle

The Company:

As a leader in custom solutions for plastics and color concentrates, this client works with global brands and manufacturers to improve end-use performance of plastic products.  Their clients rely on their blend of innovative thought, color technology, and thorough market research.

The Case:

Our client discovered a large volume of masterbatch had been manufactured with a PET-G carrier (Polyethylene terephthalate – Glycol) rather than with the specified PET (Polyethylene terephthalate)—and forwarded for vitamin bottle production.  The Keyplast colorant used in the masterbatch had not been tested in PET-G; and therefore FDA compliancy was possibly violated.  With hundreds of thousands of vitamin bottles already on store shelves across the United States, the recall potential was serious.

The Solution:

Our client turned to us for guidance, and we quickly put our technicians and Product Stewardship team together to conduct an accelerated ten day FDA migration study.  We continued the testing through the standard 45 day period and validated our dyes would not migrate out of this PET-G.  As a result, our client avoided a massive recall and probable liability claims.