Medical Device Packaging

Packaging comprises a crucial step of the finished device manufacturing process. The packaging of a product not only protects it from environmental elements, it also acts as the face of the product and the company. So, this week we sat down with our packaging and quality teams to find out more about medical device packaging and the various solutions Biomerics has to offer.

What is packaging? What processes does it encompass?

“Packaging encompasses the processes necessary to bring the components of a product or kit together so that it can be presented to the end user in a proper manner and protected during distribution,” explained Patrick Middleton, a Value Stream Leader at Biomerics. “Packaging encompasses a variety of activities, and, depending on the application, can become very complex.

“Labeling is typically the most common activity associated with medical device packaging. Labeling is the process of creating, printing, and placing descriptive and FDA compliant labels on components/products held within the package as well as on the external package itself.

“Traying/kitting is another common packaging activity that medical device manufacturers utilize. Traying/kitting is the placement of products and/or components into a tray or kit where they can be sealed for future use.

“Typically, medical device packaging activities also include pouching and sealing activities. Pouching is used (both inside and outside of a kit) to protect and group products/components. Sealing is used to protect kits and pouches from outside elements.

“Boxing, another popular packaging activity, results in two distinct outputs: a shelf box and a shipper box. A shelf box is the box that products and components are directly placed in. It is usually decorated with the company and/or product brand as well as a description. The shipper box is the box that the shelf boxes are placed in for shipping and distribution. It is used to protect the contents during transit.”

Sophia Pollock, a Value Stream Leader for Biomerics, added, “Packaging also includes the quality assurance (QA) and palletization of the finished, packaged product. Although QA doesn’t usually come to mind when people talk about packaging, the QA processes performed on the final packaged product are crucial. Packaging QA is the last chance to find any problems with the components, the device, or the packaging itself. Palletization is important because it allows for the proper shipping and handling of the finished product.”

Sealing

At what stage in the finished device manufacturing process does packaging happen?

“Packaging takes place right after assembly,” explained Sophia. “Once the product is completely packaged, it is distributed to the customer, or sent to a sterilization facility, depending on the specified requirements.”

“There are points along the manufacturing process where certain ‘primary’ packaging activities occur,” added Patrick. “These ‘primary’ packaging activities could include the bagging of catheters after a secondary operation, or the placing of molded components into a tray for future assembly and packaging.

“However, finished device packaging happens after all assembly and sub-assembly processes have been completed. This is the packaging that the patient, physician, and the other people in the operating room will see.”

When speaking about the device as a whole, does packaging account for a significant amount of time and/or cost?

“Depending on the product, packaging can have higher cost and time requirements than other activities in the finished device manufacturing process,” explained Patrick. “Generally, packaging is labor intensive, which can cause certain costs and process times to run higher compared to other automated processes. Also, because the packaging creates the face of the product, we want to ensure that it conforms to specifications and satisfies requirements, which means time and great care must be taken.”

“The quality assurance requirements can also contribute to the amount of time and cost it will take to package a product,” added Sophia. “Ensuring that processes are operating within specified windows such that bags are properly sealed for sterilization or that all components of a kit are labeled and packaged properly can increase processing times and costs. Although the added seconds may not seem like much at first, they can compound as production continues to grow.”

What is a common trap manufacturers can fall into when it comes to packaging? How can it be avoided?

“The incorrect sizing of trays, boxes, and kits,” explained Sophia. “This usually comes from noise or a lack of communication within the supply chain. Products may be manufactured and assembled according to one document revision, but somewhere down the supply chain the supplies and materials may be ordered according to another revision. This situation can not only cause packaging problems, it can also cause quality and regulatory issues as well, not to mention the cost implications.

“To avoid this trap, manufacturers must have a strong, robust quality management system that includes a way to efficiently communicate changes to components, products, and processes to all members of the supply chain.”

“Missing and/or incorrect components and products within a package is a problem I’ve seen manufacturers run into in the past,” added Patrick. “This not only has processing cost and time consequences (because the package has to be reopened, scrapped, etc.), it also carries significant procedural consequences. A missing part or component could cause severe problems in the operating room.

“To avoid this, design and manufacturing engineers should set up packaging processes that are robust and consistent. Building foolproof systems such as part verification (i.e. physically counting out components of a kit), weight verification (i.e. a process in which kits are weighed to ensure consistency), and drawing verification (i.e. matching the completed package to a drawing) into the packaging process can help lower human error considerably. Proper documentation, work instructions, and standard operating procedures to support the process are also necessary and can lead to even lower non-conformance rates. If the process is planned appropriately and operators are trained and supported correctly, the chances of this problem happening can almost be eliminated.”

“It’s important to note that, similar to other processes within medical device manufacturing, packaging must also go through qualification,” added Jake Wakely, VP of Quality at Biomerics. “Both the packaging itself and the packaging process must be validated.

“Packaging provides a barrier to outside elements including, in some cases, sterilization. If the packaging of a product doesn’t meet the requirements for sterilization, transportation, or safety, it can cause regulatory and quality issues. Along with a lack of proper planning up-front, misunderstanding the importance of packaging qualification can significantly increase the cost and amount of time it will take for a product to go to market.”

Boxing

What packaging solutions does Biomerics offer?

At Biomerics, we understand the stringent packaging requirements of the medical device industry. We also understand the importance that packaging plays in the function and presentation of devices, which is why we offer complete packaging solutions in ISO Class 8 (100,000) environments. Our cross-functional engineering team will partner with you to design, develop, and validate packaging and packaging processes in compliance with regulatory standards. Our manufacturing expertise and experience enable us to provide labeling, pouching, sealing, traying, kitting, shrink-wrapping, and boxing solutions that meet complex requirements. Along with our assembly, sterilization management, and fulfillment services, we can truly be your one-stop sourcing partner.

To learn more, send us an email (csr@biomerics.com), give us a call (801-355-2705), or visit the Packaging section of our website.

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