Packaging Precision

North Anoka Control System’s PurePouch™ packaging machine brings faster, safer, simpler packaging to medical device manufacturers.

NACS Inc. President Todd Olson demonstrates the PurePouch™ machine’s ability to package medical devices of varying shapes and sizes.

North Anoka Control Systems, Inc. specializes in custom process automation for the tightly regulated medical device manufacturing industry, and has clients in Minnesota and across the United States. The engineering firm’s mission can be described in one word: efficiency.

“When companies are moving to higher production levels or taking steps to make their products more repeatable and reliable, NACS looks at their processes to determine what level of automation they need, and what volume they need,” explains Todd Olson, NACS president.

Most of the automation solutions are specific to the processes of each client company, so NACS designs them, then turns the plans over to its customers for production. One exception is the PurePouch™ packaging machine.

In 2002, a client had asked NACS for help in streamlining its medical device packaging process. At the time, bags for most medical devices were wound on a roll, then cut to size. Operators used gloved hands to open each bag, drop each medical device into a bag, heat-seal the bag, and send it off to sterilization. If bags required printing, the bag roll was first unwound, printed on, then rewound before being cut into individual bags. Olson says the whole process took multiple operators between four and eight seconds per bag. A single operator required between eight and 20 seconds per bag.

NACS engineers have since combined multiple automations in one machine to allow one operator to package one medical device every three seconds. Most medical device packaging is made of polyethylene and Tyvek® material. Engineers realized that cutting through the polyethylene layer of the bag while keeping the Tyvek® layer intact would allow them to open bags while keeping them on the roll. They also knew that eliminating the need to open each bag manually would expedite the process, so they incorporated a component that blows each bag open with a stream of air. Operators drop the medical device in the opened bag, and then the machine heat-seals and cuts it, dropping finished products into a bin.

NACS engineers soon realized they had developed a product that could help other companies in addition to their client. As a result, the company created a separate PurePouch™ LLC to market and sell the PurePouch™ machine.

Apart from reducing time, Olson says the PurePouch™ machine also reduces error by decreasing the number of times each bag is handled. The machine adapts to different bag sizes, and cuts bags completely instead of perforating them to minimize debris. It also saves “recipes” for bag sizes and printed designs, facilitating faster changeover times.

Olson says the machine’s most valuable offering to customers may be peace of mind. A digital screen called a Human Machine Interface or HMI counts out the number of bags in each batch as they are completed, and records the temperature, force and time of each heat-seal for process validation during FDA audits. If metrics fall outside the allowable range, the machine alerts the operator not to run product. Olson hopes sales of the product will increase as more potential customers learn about its capabilities.

“It’s a quantum shift for people from the other way [of packaging medical devices] to this way, so not a lot of people know about it,” he says. “The challenge lies in marketing and telling the story.”

To learn more about NACS Inc., go to www.nacsinc.com