In Part 1 , we discussed why not to procrastinate in your packaging design. The next step to protect your device and get it approved is to have a packaging expert take a look. Experts in ISO11607 can ensure that the material and design will meet or exceed your needs—and increase validation confidence. These are the seven mistakes most often seen by our packaging experts:

1 Size, Weight, and Geometry – By understanding what the device is, along with its features – weight, dimensions and material textures, your packaging partner can narrow design format and material choices.

• If the product is large or heavy, additional strength and stability from the packaging solution may be required by using an HDPE card or tray with lid solution, for example.

• Does the device have sharp components or rough edges that need to be protected?  Perhaps, a puncture-resistant material is necessary to avoid breaching the sterile barrier.

• If the device is bulky, it may require reinforced packaging materials or design.

• .Are there multiple components that need to be organized and secured? If it is a kit or contains multiple pieces, the configuration of and access to each part must be planned and controlled.

2 Barrier Properties – Understanding shelf-life expectations and how sensitive your device is to moisture, gas and light will help drive packaging material selection.

• If the device is sensitive to light, moisture, oxygen or requires water resistance – a barrier film or foil material will be required to protect the device. 

• How long will your product sit on a shelf unused? If shelf life is one year versus maintaining efficacy for 5 years, it very likely could drive material selection.

3 Sterilization – Achieving and maintaining sterility of the medical device is one of the key challenges when designing a sterile barrier system – and required for patient safety.

• The sterilization modality will drive packaging material compatibility and choice. For example, if using ethylene oxide (EO), packaging must be porous while also providing microbial barrier until point of use.

• In addition, packaging design consideration must consider critical parameters of the sterilization process and how vacuum, humidity and heat can affect packaging—and potentially the device.

4 Aseptic Presentation Method – The packaging design is critical to enable aseptic transfer of your device into the sterile field.

• Packaging engineers can design risk out of the aseptic presentation process by incorporating intuitive design and usability features. The right packaging design ensures that clinicians can easily open and safely present the device.

5 Distribution – Understanding distribution channels, handling methods, climate and altitude conditions that could impact the packaging during transit are considerations for packaging design and material decisions.

• Packages that are undersized or oversized are more likely to become damaged or have a breach in the sterile barrier – costing time, money and compromising patient safety.

6. Equipment Availability – Validating the manufacturing process to ensure it is repeatable and reproducible is a requirement of ISO11607. Understanding what equipment is available or needs to be procured for forming, sealing and assembly is important consideration when designing your packaging system.

7. Don’t Reinvent the Wheel

For all the minutiae you manage, whether on the device or packaging side, practicality and common sense must also prevail. There is one thing everyone in this industry knows: getting to market quickly is important. And so, rest assured if there is an immediate packaging need identified along your journey, Oliver Healthcare Packaging will help you, today. We offer versatile, ready-to-go options, such as our Quick Ship Stock Pouch Program. Our Stock Pouch Program features in-stock Tyvek pouches in four common sizes, to support validation, testing and current inventory needs.

Oliver Healthcare Packaging thrives on the excitement and inspiration of our client innovations. It’s a privilege to be trusted with major responsibilities and collaborative relationships where we can help you get to launch. For additional information and resources, please visit our website or contact Connie Anderson (canderson@oliverhcp.com) with your packaging needs.