Requirements for Medical Device Packaging

Consumer packaging for Medical Devices

Medical devices are essential pieces of equipment necessary for completing surgeries and evaluating patient symptoms. There are strict regulations for these items, as they must be sterile and in top-functioning condition for medical professionals to use them safely. These requirements make proper packaging essential.

Medical device packaging must meet specific standards to be fit for shipment. In particular, it needs to ensure products arrive in their best condition and without contaminants. Understanding packaging requirements prepares you to pack medical devices correctly. Learn more about medical packaging and how Great Northern Packaging can help.

Common Types of Medical Packaging

Medical professionals can only use clean and high-functioning medical devices. When hospitals and other medical facilities order devices, the shipments must take the proper protective measures. For instance, they should have three layers:

  • Primary: The first layer is usually a sterile barrier that shields the device from contaminants. It can contain double or triple layers.
  • Secondary: The second layer separates the sterile barrier from the outer shipping packaging. It ensures the initial layer stays as clean as possible.
  • Tertiary: The tertiary layer is usually the outer shipping case that recipients receive. Devices might go directly to facilities or to stores.

Medical Packaging Requirements

Requirements for medical device packaging

No matter what type of medical packaging you choose, it must meet specific safety requirements,

  • Durable: Medical device packaging’s primary goal is to deliver items safely. To achieve this goal, the packaging must be able to withstand extreme temperatures, weather conditions or other hazards. Distribution varies widely in length and environmental conditions. The packages could be exposed to harsh weather that harms materials, threatening the internal components. To avoid this, your medical packaging must contain wear- and tear-resistant materials. The packaging should also maintain stability after years without opening. For instance, if a hospital purchases devices to fill backup inventory, the boxes should still have firm structures.
  • Sterile: Medical equipment needs to stay as clean as possible for safe use with patients. Manufacturers produce devices in their best condition, and the shipping materials must preserve this state. Many distributors use sterile layers to keep moisture or oxygen away from the equipment. It’s vital to use the right sterilization measures for specific tools. For example, some equipment might need moisture-prevention layers because water would cause it to corrode. Using multiple layers helps to preserve sterilization.
  • Fully sealed: Packaging should also be comprehensive, completely covering all device points. If any equipment components are exposed to the elements, they could become unclean or unfit for use. It’s best to choose packaging that fits items closely. Too much room could cause unnecessary movement, while too-small packages might be crammed. Manufacturers should also inspect the sealing thoroughly and ensure they will stay closed. Seals also have to withstand weather conditions and other environmental circumstances.
  • Rigorously tested: Manufacturers should also use the right testing protocols to make sure packaging meets all the above criteria. The International Organization for Standardization (ISO) outlined standards for sterile and non-sterile devices under ISO 11607-1 and ISO 11607-2. These standards list validation requirements for packages containing medical devices. For instance, you must conduct visual inspections and stability testing of current packaging materials. You can also use distribution simulations to test how the materials will perform during shipping.

Why Choose Great Northern Packaging for Medical Device Packaging?

Great Northern Packaging is a leading provider of packaging solutions. Our protective packaging offers the durability and support you need to safely transport medical devices.

We set ourselves apart from our competitors with attributes like:

  • Extensive experience: We’ve been in business for more than 60 years, giving us broad packaging experience. We have served many different industries and client types, allowing us to understand the specifics of particular packing situations. We have over 70 structural designers and engineers that are ready to meet your needs. Our team works with you to develop the optimal design for medical device security.
  • Customized packaging: Our customized packaging options help clients meet business and safety goals. Vivid prints assist with brand awareness and product conversions. We offer various print options, from flexographic print to digital prints. Our team helps you pick the print option that matches your design goals and budget preferences. We encourage customized prints and can offer specific instructions for how to package medical devices.
  • Versatile offerings: Great Northern Packaging also offers many different packaging types. Our offerings can suit a wide range of medical devices. We thoroughly test all of our products, ensuring they’re fit for distribution. We offer vibration, compression and free-fall testing to make sure your medical devices remain secure in any environment.
  • Sustainable materials: We are committed to environmentally friendly practices. We use sustainable practices that extend materials’ life spans. Our packaging materials originate from recycled components like newspapers and containers. We also minimize waste during the production process, reusing materials wherever possible. Our prints use water-based ink, eliminating the need for lead inks or other harmful substances.

Choose Great Northern for Medical Device Packaging

Contact Great Northern Packaging Today

No matter your medical device specifications, Great Northern Packaging can help you develop secure and functional packaging. Our wide range of protective packaging materials can meet your specific shipping needs. We use our expertise in development, prototyping and design to create ideal packaging solutions.

We also have in-house certified International Safe Transit Association (ISTA) technicians that thoroughly test your finalized packages. Ensure your devices stay secure in many simulated situations, from free-falling to rough handling. You can trust your medical devices will stay protected until they reach their intended destination.

We’re ready to help with any packaging needs. To get started with Great Northern Packaging, contact us today.

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