Automation Optimizes Medical Device Packaging and Palletizing
Just as in the manufacturing of medical devices, end-of-line packaging and palletizing of products intended for patient healthcare must also meet strict governmental regulations. At the same time, to remain competitive, packaging and palletizing of these sensitive products must be done efficiently and cost effectively. Fortunately, there are automated options available that not only boost productivity and cut costs, but also ensure that medical devices are handled carefully, safely and securely during end-of-line processing.
Special Considerations for Packaging and Palletizing Medical Devices
The manufacturing of medical devices is overseen by the U.S. Food and Drug Administration (FDA) and all medical devices must meet the FDA’s Quality System Regulation (QSR, essentially best practices for medical manufacturers), which mandates that every step from assembly to packaging to shipping and delivery must be performed in a way that consistently meets specifications regarding safety, sterility, consistency and precision.
This means the FDA is just as rigorous about the packaging, handling and transportation of medical devices as it is about the manufacturing process for these products.
Specifically, the FDA mandates that packaging, palletizing and handling of medical devices is carried out in a clean, safe environment, that the integrity of the package is guaranteed and that all products are traceable from the point of manufacture right on through to packaging and distribution and the point of purchase to prevent medical errors, enhance supply chain security and assist in cases of recalls. Further, the FDA requires that manufacturers of medical devices use packaging and palletizing methods that protect against environmental conditions, keep products sterile and germ free and prevent damage or exposure during transport. FDA’s QSR contains a section specific to packaging control, which states: “Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling and distribution.”
This means the equipment used for packaging and palletizing medical devices must comply with FDA standards and regulations for cleanliness, integrity and traceability, while also efficiently, reliably and carefully handling high volumes of sensitive devices to avoid damage.
Automated Medical Device Packaging and Palletizing Benefits
For these reasons, many manufacturers are turning to automated solutions to help optimize the packaging and palletizing of medical devices while also meeting FDA requirements. Not only can end-of-line packaging and palletizing equipment enhance the speed of these activities and ensure accuracy and consistency during end-of-line processing, but improvements in automation, such as enhanced grippers and end-of-arm tooling, can prevent damage to delicate medical devices and instruments during handling. Benefits of automated packaging and palletizing for medical device manufacturing include:
|Contamination-Free Packaging, Sealing and Palletizing
|Using automation to pick and place items into cases, pack and seal cases or palletize medical devices and instruments, pre-dosed medications, dental instruments or other items that must be kept sterile reduces the chances of introducing contamination as it removes the human element from the process. In addition, when equipped with proper end-of-arm tooling, pick and place robots are less likely to damage packaging, ensuring that the product within remains sterile and contaminant free.
|There are many regulations concerning the accuracy of labels and packaging of medical devices. Properly programmed automation is unsurpassed for accuracy and consistency, especially when compared to manual labor. This assists with meeting regulations regarding labeling and traceability. Further, employing robots enhanced with vision systems can provide higher accuracy and reliability than the human eye during inspection of products, packaging and labeling. Automation can also be used to remove any products that do not meet programmed specifications for quality, defects or labeling.
|Automation can improve the speed and accuracy of packaging and palletizing lines as robots and automated equipment move at a significantly faster pace than manual laborers.
|In addition, because automation reduces the risk of contamination during packaging and labeling, product waste is reduced, saving costs on materials and labor. With less human intervention, packaging, labeling and palletizing errors will also be nearly eliminated, which reduces the chance of product recalls due to packaging mistakes, further boosting the cost effectiveness of automation in these applications.
|As automation can be programmed to do a specific job and do it with accuracy and consistency, it is easier to meet FDA requirements regarding labeling, packaging and palletizing medical devices and makes the traceability component easier to comply with throughout the manufacturing, packaging, palletizing and transport of produced devices.
Automated Packaging Solutions for Medical Device Packaging and Palletizing
Because automation ensures efficient, accurate and compliant packaging and palletizing of sensitive medical products, manufacturers and distributors of automated equipment offer a variety of options to meet the end-of-line needs of each manufacturer. There are hard (fixed) automation systems and robotic automation systems, so finding the most suitable solution will depend on the product itself, the package that will be used and whether it is high-volume, mixed production or a single product and packaging configuration, as well as speed requirements and available space. But the most common solutions include:
- Automated palletizers are an ideal option for single- or multiple-packaging lines. Automated palletizers can be designed to keep medical devices safe and secure during the palletizing process and can stack items in a manner that prevents damage to the contents of the packages.
- Robotic palletizers offer flexibility, reliability and security of items as they are capable of quickly and efficiently managing a variety of pallet configurations, customizing pallets and layering individual packages to produce a stable pattern to prevent damage during transport and delivery. Optimizing the pallet configuration is also likely to reduce shipping costs as there will be more products on each pallet. Robotic technologies and vision systems can also be integrated with labeling systems to help with label application and inspection to further enhance compliance with FDA labeling and packaging regulations.
- Case packaging systems are available as both hard automation or robotic automation. While hard automation systems are faster and are best for single-size products, robotic systems excel in situations where more agile and flexible technology is needed for picking multiple case loads at the same time.
- High-speed pick-and-place robots are another option where accuracy and repeatability are needed to package fragile or sensitive medical devices as today’s end-of-arm tooling options permit precision and delicate handling.
Representatives at JHFOSTER are able to provide more information about the ways in which automation can optimize the packaging and palletizing of medical devices, while also meeting legislative requirements for package integrity, sterility and traceability in a cost effective, efficient and reliable manner.