Automation of the thermoforming process has been embraced in the medical packaging industry quicker than in other markets.
Originally driven by stringent quality requirements and the need for high levels of repeatability, automation has brought other benefits to medical packaging producers, including facilitating higher and more predictable throughput and addressing the challenges of attracting, training, and retaining a quality manufacturing workforce.
What’s different about medical packaging?
Thermoformed medical packaging is designed to protect items ranging from implantable medical devices to surgical instruments. The selection of materials and the forming and sealing processes ensure the integrity of the sterile barrier system is maintained during shipping and handling until the product is opened.
Packaging must protect products from damage during shipping by securely holding each item in place and separating multiple items packaged together from damaging each other. For sharp objects, such as needles, screws, and drills, the packaging must protect the safety of the people handling the package.
Polyethylene terephthalate glycol modified (PETG) and high-impact polystyrene (HIPS) are often selected for medical packaging applications. PETG is created by adding a glycol modifier to PET making it slightly softer for tighter seals and more suitable for withstanding high-temperature sterilization processes. HIPS plastics are impact-resistant and clear and have hygienic qualities.
The entire package must withstand temperature and pressure extremes of the sterilization process. The flange must have the thickness, rigidity, and smooth surface to accept and maintain a hermetic seal to the Tyvek lid, and the sidewalls must have the strength and thickness to prevent cracking and leakage during transport.
The most challenging aspect of medical packaging design is often isolating individual items into separate compartments and locking them in place. When properly designed and manufactured, undercuts allow each part to be snapped into place and held securely.
Most medical packaging applications call for enclosing the thermoforming machinery in a protective enclosure to minimize exposure to airborne particulates that can cause gaps during the hermetic sealing process. It’s imperative to eliminate static that can attract particulates and ensure the cutting process doesn’t generate particulates that can migrate to the product.
Isolating the system from ambient air and temperatures that cause fluctuations in the heating of materials and in the air pressure of pneumatic components is also important.
The special requirements for medical packaging have led to the wide-scale adoption of form/cut/stack thermoforming systems. Simpler, less costly contact heat systems are suitable for a small fraction of medical packaging applications because they lack plug assist capabilities required for complex geometries and higher clamping forces that form/cut/stack systems offer. Contact heat systems are primarily used for simple package designs and low production volumes.
Form/cut/stack systems are usually enclosed, protecting the process and product from airborne particulates and ambient temperature and humidity. They can be more fully automated and therefore more precisely controlled, especially machines with 100% servo motors and drives.
Investment in automation offers advantages in medical packaging manufacturing. More precision and control results in higher repeatability, which means higher quality products, fewer defects, and less waste. The process improvements achieve faster cycle times and predictable output, for higher throughput and scalability.
Precise control and repeatability are critical to the calibration and production consistency required by standards and government regulations for medical packaging, such as ISO 11607:2019 and Title 21 CFR Part 11. Automation may also include vision systems and other inspection technology that provide automatic, continuous real-time quality control.
Medical packaging manufacturing faces the same workforce challenges as all industries. The operation of earlier generations of thermoforming equipment was often known as more of an art than a science, with operations acquiring a feel for what works after decades of experience. Veterans of the industry are moving on to other roles or retiring, and it’s difficult to transfer these skills to new equipment operators, especially when employee turnover rates are high.
Automated systems are less labor-intensive because instead of requiring one or more operators per production line, a single operator can cover multiple lines. This requires machines to autonomously perform forming, cutting, and stacking processes with little or no hands-on engagement by the operator. For high volume production, robotics is employed to automatically perform downstream packaging and palletizing functions.
The procedures for changing tooling between SKUs and replacing roll stock also need to minimize human error and effort. The right tooling needs to be installed in exactly the right way for every production run, and roll stock can weigh up to 1,500 lb. Thermoforming equipment should be designed with procedures and tools for streamlining these processes and preventing errors with ergonomic aids for lifting and correctly positioning heavy objects.
The human-machine interface (HMI) must be designed to be easy-to-learn for new employees while also being efficient during production every day. The latest HMI systems employ large high-resolution displays that support multitouch gestures, taking advantage of skills new employees universally bring with their years of smartphone experience. Like smartphone apps, new interfaces should require little training and no paper documentation.
The whole concept of a form/cut/stack thermoforming machine is integrating and automating multiple functions in a single system. Medical packaging manufacturers have been at the forefront of the trend toward automation, initially driven by the need for high quality, repeatability, and traceability. Automation also increases scalability and throughput. The third driver of automation is the need to address labor shortages and high turnover by making processes more productive, less labor-intensive, and easier to learn.
Learn why and how you should upgrade your technology in a fast-changing industry.
About the presentation Andrew Russo, CIO of BACA Systems, explains how the demands of moving to next-generation manufacturing methods coupled with the speed, mobility, and flexibility demands of its business forced the company to make some hard decisions. Russo details how BACA Systems justified the need to replace a relatively new ERP system, saw it as an opportunity to transform its entire business, and implemented a new platform in under six months. You’ll leave this session with a deep understanding of:
• How legacy, dated, and ill-suited technology prevents your manufacturing business from moving forward. • Why this manufacturing company committed to Salesforce as its business platform to manage everything from sales leads, to order execution, to aftermarket service and support. • How it built a plan to quickly migrate to Rootstock Cloud ERP during the height of the pandemic. • Where you need to focus as you consider next-generation manufacturing capabilities. • Why it’s never too late to overcome past technology decisions to prepare for tomorrow’s growth.
Meet your presenter Andrew Russo has a degree in business administration from Kettering University and has been in the industrial automation industry for more than seven years. He currently leads the information technology team at BACA Systems. He’s a six times certified Salesforce consultant who has a vast array of experience implementing and configuring Salesforce to meet complex business needs in a simple and user-friendly way
About the companies BACA Systems develops and manufactures fabrication solutions for the countertop industry. We have more than 400 Robotic SawJet machines installed across North America. When the company faced exploding demand threatened by fragile supply chains and tight labor markets, we quickly realized we needed a modern, connected foundation to support our fast-changing business in a faster-moving world. Rootstock Software develops and implements cloud enterprise resource planning (ERP) software to help manufacturers and distributors deliver personalized, 360° customer experiences and build operations that scale and out-service their competition. Rootstock Cloud ERP lets organizations take a more customer-centric and project-oriented view of operations across a robust suite of modules, including order management, manufacturing operations, supply chain, and financial management. When combined with the Salesforce Platform, companies gain complete visibility to their entire organization and customer journey.
3rd Stone Design uses the machine to cut production time by more than half.
3rd Stone Design’s 4-axis vertical machine center is up and running to accelerate its product development cycles.
“What used to take us a week or more to order from our outside vendors we can now design, machine, and install in two days,” said Sam Lopez, managing director of engineering. “The addition of a Haas vertical machining center has increased our throughput, our capabilities for miniature and precision components in medical devices, and custom fixtures and tooling specific to client projects.”
“Our work spans a wide range from high volume consumable plastic components to low volume capital equipment used in medical procedures. These different applications require custom componentry in original materials that must withstand sterilization and durability testing,” said Robert Miros, CEO and founder of 3rd Stone Design. “The ability to produce parts of the correct materials in prototype quantities in a fast production style allows us to iterate and complete medical device development in fewer cycles.”
The company uses the machining center to make molds for silicone wearable devices, vacuum form tooling for plastic biological trays, and custom machined aluminum heat sinks for thermal management. The variety of solid material parts that can be produced has changed the way the company thinks about prototyping exercises and alpha and beta unit builds.
Discover ways to successfully make your company more sustainable.
Meeting your environmental goals can be daunting. Lean manufacturing focuses on creating the best bottom line, but a sustainability strategy can create large overhead costs. While these two seem to be in conflict, they lead to the same goal: eliminating the potential for wasted resources. In fact, a robust sustainability strategy can save a manufacturing plant more money long-term despite early costs. Sustainability programs are now part and parcel of maintaining a strategic advantage over competitors and seizing opportunities for increases in market share. Throughout the last decade, global manufacturers have relied on Industry 4.0 and the Industrial Internet of Things (IIoT) to help them increase efficiency, reduce energy usage, and reduce manufacturing costs via optimized production programs. These programs improve environmental operations and also help companies introduce products to market faster and more efficiently. The move toward a sustainable manufacturing atmosphere is multifaceted, complex, and contains a variety of challenges unique to each manufacturer. Efficient industrial automation processes not only simplify the transition toward a green production environment but also unlock new and innovative opportunities for manufacturers to further modernize and optimize their industrial automation infrastructure. Join us for an enlightening discussion about why preventative maintenance matters, examples of real-life savings from manufacturers just like you have found by focusing on energy efficiency, how to find out if an energy-efficient climate control program could qualify you for a local rebate program, and simple ways to reduce your own energy usage and costs.
Meet your presenter Since joining Rittal in 2019, Weston Six has consulted on best practices on energy efficiency, helping customers to reduce costs and get the most out of their technology. Through Rittal’s energy efficiency inspection program, he assesses customers’ needs, both for maintenance and cooling, to find the best solution for their plant. With 10 years of experience in both services and technology, Six provides expert consultation to help customers meet their goals.
About the company Rittal manufactures industrial and IT enclosures, racks, and accessories, including high efficiency, high density climate control, and power management systems for industrial, data center, outdoor, and hybrid applications. Rittal's off-the-shelf standard, modified standard, and custom-engineered products are known throughout as high quality, affordable solutions for practically any industrial or IT infrastructure application from single enclosures to comprehensive systems.
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