September 24, 2018
At TEQ, we feel it is important to understand the importance of the potential harmonization between ISO 11607 and the EU’s Medical Device Regulations. That’s why we partnered with PMMI to write a blog. To hear more about our capabilities, visit our website.
Exploring Thermoform Packaging for Medical Devices
By Todd McDonald, Director of Sales and Marketing, TEQ
TEQ has worked with global medical device manufacturers for many years, and when they started asking for capabilities and manufacturing in Europe, we listened. In 2016, TEQ acquired Plastique, a thermoforming company with locations in the UK and Poland.
Now that we operate in multiple locations, we need our cleans rooms to operate under the EU’s Medical Device Regulations and the ISO 11607 Standard. And there has been a push to harmonize these two standards. Part of harmonizing the standard is the ability to prove aseptic presentation. Being able to aseptically present medical devices in a sterile environment is becoming more important than ever and is likely going to become part of the ISO standard.
With many ways to package a medical device, it may be hard to decide which route to take. But packaging a medical device with a thermoformed package can have the following advantages:
- Product Orientation: A nurse may need to quickly confirm a product’s orientation and how to grab it. With a thermoformed tray, a nurse can be sure that the medical device stays securely in place in the intended location so he/she can remove it swiftly and confidently.
- Handling Assurance: To make ensure a device doesn’t compromise sterility, a nurse needs to control the movement of a device as its package is opened. A thermoformed package is more likely to ensure there is no unnecessary rotation or accidental removal. In fact, in a Packaging Digest article, one nurse stated that “’we don’t like these,’ referencing the header bag. ‘There’s not as much control.’”
- Clarity: A nurse can find it beneficial to see and identify the product clearly so he/she can better present the device or see any potential defects.
- Consistent Opening Experience: Incorporating a good peal area in the package design can allow a nurse an easy access point for pealing the lidding back from the package.
- Additional protection: With rigid plastic, a medical device is protected in sensitive device areas. For example, a package can be designed so a syringe will not get depressed.
- More ergonomic: A pouch can require both wrists to twist to open, putting repetitive strain on both of the nurse’s wrists. With a sealed thermoformed tray, only one hand is opening the seal while the other is holding the tray in place.