By Andrew Gladd, Life Science Outsourcing (LSO)
Selecting the right packaging for your medical device is crucial to ensuring sterility, regulatory compliance, and cost efficiency. While custom packaging is always an option, pre-validated packaging solutions offer a faster, cost-effective alternative. But how do you determine if your device is a good fit for pre-validated packaging options? At LSO, we’ve made this process easier than ever with our free ‘Will It Fit?’ calculator.
Why Consider Pre-Validated Packaging?
Pre-validated packaging solutions are pre-tested to meet regulatory standards for a 5-year shelf life,. This significantly reduces time-to-market and lowers costs associated with testing. However, to take advantage of these benefits, your device must fit within the existing dimensions and design constraints of available pouches or trays.
Key Considerations for Determining Fit
- Device Dimensions – The most critical factor in determining fit is the size of your device. Measure the length, width, and height accurately to compare against available packaging options.
- Device Shape – Irregularly shaped devices, sharp edges, or complex contours may require additional consideration to ensure proper protection and sealing.
- Sterilization Method Compatibility – Different pre-validated packaging options are designed to work with specific sterilization methods, such as ethylene oxide (EtO), or gamma irradiation
- Barrier Protection Requirements – Consider factors such as moisture sensitivity, puncture resistance, and material durability to ensure packaging integrity.
- Regulatory Compliance – Ensure that the pre-validated packaging meets ISO 11607 and FDA requirements for sterile barrier packaging.
LSO’s ‘Will It Fit?’ Calculator: A Free Tool to Simplify the Process
To streamline the process of determining fit, LSO offers a free ‘Will It Fit?’ calculator on our website. This intuitive tool allows you to enter your device dimensions and type, instantly providing results on whether a pre-validated pouch or tray exists to accommodate your product. If a match is found, you can immediately move forward with testing and implementation. If no direct fit is available, our experts can advise on alternative solutions or minor adjustments that may make a pre-validated option viable.
Next Steps
If you’re looking for an efficient way to package your device without the time and expense of custom validation, start by using our ‘Will It Fit?’ calculator. It’s a fast and easy way to explore pre-validated packaging options and get one step closer to a streamlined product launch.
Try it today at www.lso-inc.com and see how simple finding the right packaging solution can be.
