The Pharmaceutical industry is stringent and regulated regarding the safety and compliance of products and medicine but for good reasons!

Ensuring the highest quality, protection and care without compromise is essential when considering factors such as an individual’s health and well-being. 

However, these requirements don’t just apply to the products but also to medicine packaging design.

For pharmaceutical products, packaging design and labeling are just as crucial. 

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Pharmaceutical packaging design must protect these sensitive products from contaminants like water, light and dust, while the labels need to be clear, concise and display pertinent information correctly.

Failure to meet these standards is a quick way to go out of business, so in this article, we will cover the major factors you need to consider to stay compliant and meet the high standards of the pharmaceutical industry.

However, despite the high standards, medical device packaging to meet these requirements has never been easier!

With the introduction of smart packaging design, quality control, tracing, and transparency have never been so easily achievable.

But before we look into this trend, let us first look deeper into medical packaging requirements.

Regulatory Bodies for Medical Devices and Packaging

Before we go into detail about the design, testing and other considerations for your pharmaceutical packaging design, it is first essential that we begin with the broad strokes.

The medical industry is strictly regulated, as we mentioned before. So before companies can even begin considering options to meet end-user requirements, they must first satisfy the regulations set in place by the government and global regulatory bodies.

The Food and Drug Administration (FDA) and the International Organization of Standardization (ISO) are the main central bodies you must comply with concerning medical device packaging design requirements.

The FDA is the US government regulation, while the ISO is an international nongovernmental organization comprising many national standard bodies.

Why do you need to ensure compliance with both FDA and ISO regulations?

Though the ISO is a nongovernmental organization, it still plays a vital role in facilitating global trade. The ISO works in 167 countries and sets forth common standards across all of them.

These regulations ensure that all products conform to the minimum international standard.

Whether your medical device is classified as a Class I, II, or III, it must meet a long list of requirements set forth by these regulatory bodies.

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These regulations include standards for labeling, data integrity, usage, sterilization, age testing, shelf life, and international distribution.

And though the actual list of regulations and requirements for every medical device class is more in-depth and extensive, most organizations and manufacturing companies employ internal or third-party departments to keep track, integrate and stay up-to-date with these requirements.

Determining the medical requirements at an early stage of development minimizes the risks of defects and costly recalls, so ensure that you meet FDA and ISO standards.

But now that you know a little more about the FDA and ISO’s role in setting standards for medical products and their packaging design, we can finally shift focus and take a closer look at how to design medical packages to meet these standards.

Considerations for Designing Safe and Compliant Medical Device Packaging

As mentioned briefly above, packaging design for medical products has several regulations, particularly on labeling, sterility and barrier requirements.

But before you can begin thinking about labeling, sterility and appropriate barriers for your package, it is essential to discuss and communicate your preferences with your chosen packaging partner first.

The specific package characteristics and films you choose can significantly alter the manufacturing process through different machine model requirements, applications and sealing elements.

It is essential to discuss your materials and packaging preferences with your selected packaging partner to prevent future problems that might require you to redo all of your pharmaceutical packaging design.

Be sure to cover things like looks versus function preferences, possible resource backlogs, prices, sealing methods and other factors, such as if you wish to utilize recyclable materials.

An unboxing experience that provide guidance

The push for sustainable packaging is becoming increasingly popular, and this must be considered with medical device packaging as well.

Your packaging partner will not determine the medical requirements for your packaging but will help you monitor these factors and offer helpful insight into concerns and considerations.

Medical Device Packaging Requirements for Sterility and Protection

After discussing the materials and other preferences with your packaging partner, sterilization and barrier properties are the next vital factor to consider.

From a design perspective, the materials used in the medical package must survive the sterilization process, maintain sterility, and serve as a viable barrier to contaminants afterward.

It is worth noting that there are various sterilization methods, such as Ethylene Oxide (EO), radiation or steam, and materials react differently to each option.

Ensure your chosen material is compatible with the sterilization method, but also keep in mind the compatibility with required barriers and protections.

Some barrier requirements medical devices may need include:

  • Oxygen
  • UV Light
  • Solvents
  • Moisture
  • Odors/Vapors
  • Acids/Bases
  • Microbial
  • Temperature

Again, the chosen material is important in determining what your package can protect against, so we emphasize communicating with your packaging partner and deciding your materials carefully.

Human Considerations and Labeling in Pharmaceutical Packaging Design

Once you’ve chosen the appropriate material and ensured compatibility with sterilization and the required protection barriers against contaminants, the next consideration is the human factor.

While protecting your device against contaminants is crucial, accessibility is also worth considering.

Your medical package design should consider the end-user and make it easy to access within their given environment while maintaining sterility when opened.

However, note that some devices might require additional design considerations to make access easy for adults, but deter children, seniors or others with disabilities from access.

Packaging for potential customers

Consider all possible situations in which your medical device might find itself and design your packaging around this to accommodate potential emotional, environmental or physical external factors.

Proper labeling and instructions also help with this.

Clear and concise instructions significantly help the end user, while proper labeling allows clearly defined claims of your device’s capabilities, which will aid in the successful launch of your product and prevent misuse by the end user.

Not including these labels or having inaccurate labels is one of the main reasons the FDA issues product recalls, so ensure your labels are correct and accurate!

Work closely with regulatory, quality assurance and manufacturing teams throughout the process and implement the labels before the testing phase so corrections can be made as early as possible.

Supply Chain Considerations

The final consideration when designing your medical device packaging is the supply chain.

As mentioned earlier, different medical devices and medicines have additional requirements for various life-cycle aspects, and the supply chain is no different.

When designing your medical device package, consider the transportation and storage requirements of your medical device.

Is it temperature sensitive? Light sensitive? Does the device require records of its movements, or should tracing be implemented on the package? Can your package even survive through rough transportation prone to contaminants?

All of these questions must be addressed when you design your pharmaceutical packaging, and this is where testing helps solve these issues.

Testing of Medical Device Packaging

After all considerations are made, and the designs have been implemented, your medical device package still needs to undergo stringent testing to ensure the implemented sterilization, barriers, and other systems are safe and effective.

From manufacturing to transit and storage, and even up to the point of contact with the consumer, your pharmaceutical packaging must meet the requirements outlined by the FDA and ISO.

Certified third-party testing laboratories are available to aid in this process and incorporate tests such as performance, accelerated aging, temperature, humidity, seal and sterile integrity testing in controlled environments to ensure accurate results.

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Some examples of requirements that need to be met during testing for medical device packaging include, but are not limited to:

  • Packaging systems must be able to protect their contents when exposed to hazardous conditions during handling, distribution and storage.
  • Seal and package strength must maintain effectiveness and safety when exposed to mechanical forces.
  • Package integrity must maintain the sterility of the barrier until opened at the point of use.
  •  The sterile barrier system must remain intact throughout the expected shelf-life of the product.

ISO 11607-01 and the FDA packaging requirements in Code 21CFR211.94 should be reviewed for more in-depth and detailed information on medical package requirements.

Though there are many requirements and regulations for medical device packaging and much to consider when designing a package to meet these high standards, keeping up with packaging trends can help alleviate these stresses.

Smart packaging and tracking technologies are beginning to grow in popularity, making it much easier to adhere to the stringent requirements of the medical industry.

Advanced sensors and indicators have been developed that can help monitor the condition of a medical product from transportation all the way to the shelf and can even improve the product’s shelf-life.

Other technologies like RFID tags and tracking stickers have made supply chains more transparent by allowing companies to gain real-time insight into the logistics and transportation of their medical device packages.

Smart packaging technologies have also improved the end-user experience by ensuring that quality, transparency, and pertinent information are available quickly and efficiently.

As smart packaging becomes more prevalent in the medical industry and various other sectors, implementing these technologies into your medicine packaging design may be worth considering.

Stay ahead of the curve and help alleviate some of the stresses of designing a package that meets FDA and ISO requirements.

Medical Packaging Design Has Never Been Easier

Regardless of the function or purpose of your medical device, the FDA and ISO will always hold high standards for pharmaceutical packaging and products.

When an individual’s health and well-being are factors, this is understandable.

But though the standards will not be lowered, and companies still need to adhere to the stringent requirements, pharmaceutical packaging design is ultimately becoming more accessible.

Yes, companies still need thorough planning and consideration regarding labeling, data integrity, usage, sterilization, age testing, shelf life, and international distribution.

However, with the rapidly advancing technology and the innovation of newer and better solutions, pharmaceuticall packaging design will only get easier.

Smart packaging is growing in all sectors, enabling packages to do things they never could before.

So if your company is looking to design a package to meet the high standards of the medical industry, we recommend considering smart packaging!


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