When a new medical device is brought to market, the focus is often on its innovative features and how it will help end users. More often than not, the device’s packaging is the last thing to be considered. Let’s look at medical device packaging best practices and what to expect from medical device contract packaging solutions.
Since 2006, the international standard ISO 11607 has become an important medical device packaging best practice. ISO 11607 outlines basic requirements for two parts of sterilized medical device packaging:
- Sterile Barrier System (SBS): A medical device’s SBS minimizes the risk of ingress microorganisms while allowing aseptic presentation of the sterile contents at the point of use.
- Protective Packaging: A device’s protective packaging gives the SBS an additional layer of protection.
These essential ISO 11607 requirements form a packaging system that helps maintain the safety and integrity of the product.
Medical devices have unique designs and indications for use, so as a part of medical device packaging best practices, you must meet specific ISO 11607 packaging standards:
- All packaging should be manufactured with well-known, traceable materials.
- Medical device packaging should be non-toxic, odorless, and non-leaching.
- Devices should be free of holes, cracks, tears, creases, and localized thinning.
- Devices should be intended for use in medical applications only.
- Packaging designs should allow for sterilization and aseptic presentation and maintain it up to the point of use.
To meet medical device packaging best practices, you must consider the design and functionality of the device, addressing the following areas:
- Intended sterilization method
- Intended use
- Application and end user
- Storage time length and expiration date
Considering these ISO 11607 packaging standards can help you avoid common roadblocks like failed packaging tests, product launch delays, and regulatory submission challenges.
What To Expect From Medical Device Contract Packaging Services
It’s common for full-service manufacturers to customize packaging solutions based on the medical device and test the packaging design to ensure it’s the right fit for your product. Once the packaging meets your expectations, the manufacturer conducts the medical device packaging process in a regulated ISO Class 8 clean room to ensure the ISO packaging standards are met.
There are four common medical device sterilization methods used by manufacturers today. Find out what they are.
When working with a contract manufacturer to develop your product’s packaging, you can avoid failed packaging tests, product launch delays, and regulatory submission challenges with the following medical device packaging design tips:
An important medical device packaging best practice is to leave plenty of time for your product’s packaging design and development, including labeling. Waiting until the end of your project to consider design and development can result in lost revenue and a delayed launch, so be sure to set aside time to work through packaging design obstacles, like device component lead times and testing durations.
Another way to overcome packaging challenges is to work closely with your product’s manufacturer. As your device changes throughout the product life cycle, its packaging design may also need to change. Working with the product manufacturer as your device develops ensures that the packaging system continues to meet requirements as features change and improve.
The final tip for a seamless device packaging design process is to understand design inputs in detail, considering:
- How is the device going to be loaded into the package during manufacturing?
- How will the device be sterilized?
- What is its intended shelf-life?
- Does the device have environmental limitations?
- Does it have features that need isolation or extra protection?
- How will the end user remove the device from its packaging while preventing contamination?
By relying on an experienced manufacturer to take care of your product launch from start to finish, you get a streamlined process that avoids costly packaging mistakes.
As a full-service contract manufacturer, Remington is an expert in medical device packaging best practices that works with you from start to finish. Our team doesn’t believe in one-size-fits-all packaging solutions—that’s why we customize packaging systems based on individual product needs.
Our proven process results in successful contract manufacturing services. These services include different types of sealing and packaging that meet ISO packaging standards for medical devices, including:
- Heat seal trays
- Heat seal pouches
- Heat seal header bags
Contact us today to learn more about medical device packaging best practices and how we can help.
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