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Initially driven by stringent quality requirements and the need for high levels of reproducibility, automation is driving higher predictable throughput and attracting, training and retaining a quality manufacturing workforce. It has brought other benefits to manufacturers of medical packaging, such as addressing the challenge of

What is the difference in medical packaging?

Thermoformed medical packaging is designed to protect a variety of items, from implantable medical devices to surgical instruments. Material selection and molding and sealing processes ensure that the integrity of the sterile barrier system is maintained during shipment and until the product is opened.

Packaging must prevent damage to items during shipping by holding each item securely in place and separating multiple items packaged together from damage to each other. For sharp objects such as needles, screws and drills, the package must protect the safety of those who handle the package.

material selection

Polyethylene terephthalate glycol modified (PETG) and high impact polystyrene (HIPS) are often chosen for medical packaging applications. PETG is made by adding a glycol modifier to PET, making it slightly softer for a tighter seal and better suited to withstand high temperature sterilization processes. HIPS plastic is impact resistant, transparent and hygienic.

Sturdy flanges, complex geometries

The entire package must withstand the extreme temperatures and pressures of the sterilization process. Flanges must be thick, rigid, and have a smooth surface to accept and maintain an airtight seal to the Tyvek lid, and sidewalls must be strong and thick to prevent cracking or leaking during shipping. Saga is required.

Often the most difficult aspect of medical packaging design is segregating individual items into separate compartments and locking them in place. When properly designed and manufactured, undercuts allow each piece to snap into place and hold securely.

Removal of airborne particulates

Most medical packaging applications require the thermoforming machine to be enclosed in a protective enclosure to minimize exposure to airborne particles that can cause voids during the hermetic sealing process. It is essential to eliminate static electricity that can attract particles and to ensure that the cutting process does not create particles that can migrate into the product.

It is also important to isolate the system from ambient air and temperatures that cause material heating and air pressure fluctuations in pneumatic components.

Increased automation

The special requirements of medical packaging have led to the widespread adoption of form/cut/stack thermoforming systems. Simple, low-cost contact heating systems lack the plug-assist capabilities required for complex geometries and the higher clamping forces offered by form/cut/stack systems, making them suitable for a small percentage of medical packaging applications. increase. Contact heating systems are mainly used for simple package designs and low volume production.

Form/cut/stack systems are typically hermetically sealed to protect 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.

Investing in automation benefits the manufacturing of medical packaging. Better precision and control means better reproducibility. This means better product quality, fewer defects, and less waste. Process improvements result in faster cycle times and predictable output, increasing throughput and scalability.

Accurate control and repeatability are critical for calibration and production consistency required by medical packaging standards and government regulations such as ISO 11607:2019 and Title 21 CFR Part 11. Automation may also include vision systems and other inspection technologies that provide automatic, continuous inspection. Real-time quality control.

Workforce management

Medical packaging manufacturing faces the same workforce challenges as all industries. Operating early-generation thermoforming equipment was known more as an art than a science, as decades of experience acquired a feel for how it worked. Industry veterans have moved on to other roles or retired, making it difficult to transfer these skills to new equipment operators, especially when employee turnover is high.

Operability

The automation system is less labor intensive as one operator can cover multiple lines instead of requiring more than one operator per production line. This requires the machine to perform the forming, cutting and stacking process autonomously with little or no operator involvement. For high-volume production, robotics are used to automatically perform downstream packaging and palletizing functions.

The procedures for changing tools and swapping roll stock between SKUs should also minimize human error and effort. Each production run requires the right tools to be installed precisely and correctly, and roll stock can weigh up to 1,500 pounds. Positioning of heavy objects.

Intuitive HMI

The Human Machine Interface (HMI) should be designed to be easily learned by new employees. Her latest HMI system features a large, high-definition display that supports multi-touch gestures, leveraging the skills new hires universally bring from years of smartphone experience. Like the smartphone app, the new interface requires little training and no paper documentation.

I’m looking forward to

The overall concept of form/cut/stack thermoforming machines is to integrate and automate multiple functions into one system. Medical packaging manufacturers are at the forefront of the trend towards automation, initially driven by the need for high quality, repeatability and traceability. Automation also improves scalability and throughput. A third driver of automation is the need to address labor shortages and high turnover rates by making processes more productive, less labor intensive and easier to learn.

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