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On the surface, it may seem that providing proper packaging for anything is straightforward.  You need a box, maybe some packaging material, and a label.  However, when you are talking about packaging medical devices that may be implanted into a patient, it quickly gets a lot more complicated.

In the following article, we will outline the essential components of medical device packaging.


Device Considerations

At the beginning stages of any project, an obvious consideration is what type of medical device you are trying to protect with your packaging.  The type of material, the density of that material, and the size of the device are critical to the packaging conversation.  Each of these factors has an impact on the sterilization method required as well as the type of packaging needed to adequately protect the device during shipment.  Some require several layers of protective packaging, while others don’t need more than a primary and secondary package.

With this in mind, it is critical to work with a contract packaging company that has extensive experience working with a broad range of devices and packaging materials so that they can make the proper recommendations on packaging type and method of sterilization.


Label Requirements

Discussions about label requirements are a step that is often overlooked until the end of the process.  Instead, we encourage that conversation to happen earlier, since it impacts the potential size of the packaging needed, the visible surface area needed to adequately read the label, and it involves discussions around the graphics, adhesive material, and ink used.  Each of these may interact negatively with the sterilization process if you aren’t careful.


Packaging and Sterilization

If your device requires sterile barrier packaging or a sterile barrier system (SBS), then there are several things to keep in mind:


What cleanroom classification is needed?

Cleanrooms are classified according to the number and size of particles allowed per volume of air. The standard for most is a Class 10,000/ISO 7-rated cleanroom, which means that the environment would only allow <10,000 particles/cubic foot. This is a high standard that ensures you are assembling the device in a rigorously controlled environment.


Given the device materials and density of the material, what type of sterilization method do you require?

The three most common methods are Ethylene Oxide (ETO) sterilization, Gamma radiation, and steam sterilization.

Your contract manufacturer should be knowledgeable about which method to apply and when, and they should also have relationships with different sterilizers who specialize in each method.


Finally, what is the size and configuration of the device?

Each sterilization method has limitations on the size of the sterilization chamber, and therefore, the device must be able to fit into the chamber easily, and efficiently use all available chamber space.  Ideally, you want economies of scale to sterilize many devices, so you want the most compact configuration you can find while still ensuring that each medical device is correctly sterilized.


Validation Testing

Validation testing is another critical element in successfully packaging a medical device for safe delivery all the way to the patient.

Validation is a broad heading that covers several different areas.

  • Cleaning validation – you want to make sure that you are testing for any chemical or biological contaminants on the device before and after it is packaged. You need to follow clear protocols and measurement guidelines to determine whether you meet the appropriate standard for a “clean” device.
  • Sterilization validation – pre and post sterilization testing is required to verify that you meet certain standards and that the sterilization method chosen has effectively reduced the number and type of potential contaminants below the required threshold.
  • Distribution validation – packaging integrity under simulated shipping conditions is important to ensure that your packaging can withstand the rigors of shipping and handling all the way from your warehouse to the end destination. Particular tests are required to determine the integrity, strength, and visible condition of your packaging on arrival.

A good design and a validation process are fundamental to provide customers and medical organizations with high-quality medical devices.


FDA Regulations

As mentioned throughout this article, medical devices are regulated by the FDA to ensure the safety of the end patient.  An essential component of the process is to understand the specific regulations and documentation required at each stage. It is important to work with an experienced contract manufacturer who has a detailed understanding of these requirements.

As you can see, medical device packaging requires very specific knowledge that must be earned over the years.  Poor packaging can cause a host of problems for medical device companies and their customers.  When you find a partner that can bring the specific, expert knowledge required, they become integral to the success of your product.

Pro-Tech Design & Manufacturing, Inc. is a full-service medical device contract manufacturer that offers innovative packaging solutions, assembly, and sterilization services for medical devices.  Please contact us if you have any questions about medical device contract packaging.


Medical Device Packaging FAQs


 What are the FDA medical device packaging requirements?

They utilize ISO 11607 as the standard to regulate medical device packaging.  It is a consensus standard between the FDA and ISO. This webpage provides additional details about the standard:

Identifying your requirements early will help you reduce lead times typically associated with packaging design for medical devices.


How do I know which sterilization method is required for my medical device?

It is typically based on the type and density of materials, environmental concerns, and device design.  Each of these is taken into consideration when determining which sterilization method to use.

Experienced contract manufacturers can save you time and resources by knowing how these factors work together to drive the decision on the most effective sterilization method.


What are the testing requirements for medical device packaging?

Usually, there is a combination of three different types of testing:

  • Microbiological – for example, Bioburden and LAL testing
  • Chemical – TOC, pH, spectroscopy
  • Mechanical – visual inspection, peel strength, distribution testing

The testing protocol is influenced by the type of device, the production and assembly process, and the method of distribution.