Tracing its materials right from their origin, Advanced Molding Technologies LLC is going to extremes to create a manufacturing cell free of contact with animal-derived ingredients.
Senior manufacturing engineer Ryan Fuhr said the project started in 2009, when a client asked about a new line of products known as “animal derived component free,” or ADCF.
“We're used to making parts for the medical industry and cleaner molding, but making sure it was ADCF was a new requirement,” Fuhr said by telephone.
For plastics, animal-derived ingredients are most common in release agents, which can be made using bovine tallow.
To certify that its products are ADCF, the Circle Pines, Minn., firm had to make sure the resins used, and the molded component, did not come into contact with any animal-derived components, such as a bag, hose or tub.
“We had to look at how it was delivered,” Fuhr said. “What do we have to change to handle the additional complexities?”
Advanced designed a system and a manufacturing cell to make products for the life-sciences firm, which Fuhr declined to identify.
The qualification process started in 2010. He said it included plenty of paperwork and great scrutiny in the way the company handled resins and products.
“You can't really test for ADCF. You have to bring in ADCF resin and make sure that it is not contaminated in any way,” Fuhr said.
The product also needed to be free of latex and bisphenol A, and put together under U.S. Pharmacopeia Class IV designations.
In the past, the customer would wash purchased molded components prior to their use in downstream processes, but this project included a “no wash” requirement, meaning more-stringent controls along the process.
Advanced's solution included a dedicated clean room setup with a work cell that included molding equipment, clean room airflow and part-handling equipment that could do everything with minimal exposure to human operators.
Fuhr said the project was challenging in the breadth of scope of what had to be examined to make absolutely sure all requirements were met. Making ADCF products is a niche market for Advanced.
Advanced employs about 100 at a 46,000-square-foot plant with Class 10,000 and 100,000 clean room space for injection molding and assembly. It has presses with 20-500 tons of clamping force.