As we reported last month, Evco Plastics celebrates its golden anniversary this year. Over the course of 50 years, the company has grown from a 1200-sq-ft building in DeForest, WI, to a thriving contract molding enterprise with nine facilities in the United States, Mexico, and China. Although medical molding represents less than 10% of its core business, the sector has been part of the Evco legacy almost from the start, and it sees medical playing a growing role as it embarks on its next half century. "Over the past few years we've made a concerted effort to grow this area as we take on more and more medical device products," Dale Evans, President, told PlasticsToday in an e-mail interview.

It was his father, Evco founder Don Evans, who put the company on the medtech map early on. "Don helped design a threaded nebulizer cap with three stainless-steel inserts for Ohio Medical more than 48 years ago," recalls Colleen Conway, Director of Business Development. "We worked with them on many more insert-molded medical products, including oxygen masks. As technology and needs changed over time, we expanded into x-ray machine components, diagnostic device housings, reaction trays, test tubes, syringes, connectors, and caps and disposables," says Conway.

Retaining that business and, indeed, growing it has been an evolutionary process for Evco, notes Dan Renz, Project Engineer. "Gone are the days of setting a mold, spending a few hours to establish a process, collecting samples, measuring, receiving customer production approval, and then trying to monitor and control the production variables later," says Renz. "Process validation has become a much longer and more crucial factor to ensure that Evco's medical customers receive products that meet or exceed their quality specifications on every shipment."

In addition to state-of-the-art quality systems, medical device OEMs typically demand "cleanroom-molding capabilities, validated and closely controlled processes for injection molding and assembly, complete traceability back to raw material state, and batch record documentation," adds Dale Evans. Evco has developed expertise in all of those areas.

Evco was an early adopter of scientific molding principles, and their application in medical molding has helped Evco to demonstrate its commitment to the medtech market. "We have [applied] these proven methodologies into medical molding by developing and documenting the molding process in written protocols developed at Evco," explains Renz. "These validation protocols are written to comply with FDA current good manufacturing practices and ISO 13485, the international quality systems standard for medical manufacturing."

The base line of these protocols consists of three phases, referred to as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), explains Renz. "IQ is used to verify that the equipment used to produce a part has been installed and is operating correctly. OQ is the workhorse phase of process development, where process limits are established and challenged by using design of experiments and measuring evaluations. The last step is PQ, which basically simulates a production run over several hours at the nominal process settings derived from the OQ phase. The PQ is used to confirm that the part will consistently meet our customers' quality requirements," says Renz.

Medical projects are accommodated at Evco's nine production plants. "For those projects that require an FDA-registered production facility with a Class 8 cleanroom environment, however, we use our medical molding facility in DeForest, which we refer to as the MED plant," says Evans. The company also operates a modular Class 8 cleanroom in its Shenzhen, China, facility, he adds, and "plans are underway to expand our China molding operations when we relocate to a new site within the next 18 months," says Evans.

— Norbert Sparrow

Norbert Sparrow is Senior Editor at PlasticsToday. Follow him on twitter @norbertcsparrow and Google+.