Peak Performance Gets ISO 13485:2016 and 9001:2015 Certifications
Toll and custom compounder gets certified less than a year after it produced its first pellet.
Peak Performance Compounding Inc. has obtained ISO 13485:2016 (medical) and 9001:2015 (industrial) certifications, the Leominster, Mass. compounder has announced.
The founders launched the company in October 2019 to offer a service-oriented option for companies looking to fill their compounding requirements. Peak offers pre-colored high quality, specialty and unique engineered products to the medical and industrial markets. It utilizes twin screw technology for processing a wide range of thermoplastic compounds, highly filled products, and precision compounds. Also, Peak offers toll processing and custom formulating capabilities for custom coloring with customer specified ingredients for a wide range of applications.
Peak also offers pellet- or- dry-powder blending, pellet pulverizing, desiccant drying and material testing. Peak is currently working towards making its medical production area humidity- and- temperature-controlled in Leominster.
Peak says the implementation of ISO 13485:2016 and 9001:2015 certifications was rigorous. The compounder worked over the course of eight months to implement these ISO processes and procedures from scratch with the help of consulting firm Cunningham & Associates. “It was very important to me that we build this business with a culture of quality first and supreme attention to detail. Implementing ISO standards from the very beginning creates a foundation for Peak to grow within these high-quality standards,” says Todd Marchand, Peak president. “ISO is now embedded in Peak’s DNA. I am very proud of what our team has accomplished in getting these certifications in place.”
Marchand sees high growth potential for Peak, as it will be filling a need for custom medical/industrial tolling and compounding, with a strong focus on its customer’s requirements. “The medical and high-end industrial markets will be our focus. We will offer a service-based compounding option with no minimum run sizes.”
Conventional molding techniques are not effective with high-temperature materials. Molders need to be aware of certain conditions and parameters to handle problems sometimes posed by high-heat injection molding.
One of the first applications for blow molded HDPE bottles was the replacement of glass for bleach packaging.
Cyclic olefin copolymer (COC ) is an amorphous thermoplastic that is finding increased utility as a blending agent in polyolefin packaging films for medical, consumer, and industrial markets.