Packaging is an essential component for every finished medical device. Unfortunately, custom solutions can add significant time and costs to a project. Additionally, if the packaging decision is left to later in the product development cycle, even more time can be wasted in generating the packaging for the device.
For many medical devices, a pre-validated packaging solution could provide a favorable alternative that reduces both the cost and time to market, as well as offering advantages such as with the regulatory submission. Having already been tested, validated, and trialed in sterilization procedures, the packaging provides for a rapid-turnaround answer for companies who don’t have specialized needs.
Addressing this opportunity as well as sharing additional insights on the benefits of its use is three members of the Life Science Outsourcing team. Alan Evans, medical package testing manager; Andrew Gladd, sales and program manager; and John Nino, CEO took time to outline the benefits of pre-validated packaging for medical device manufacturers.
Sean Fenske: First, can you please explain what pre-validated packaging is and how it compares to custom-developed packaging for orthopedic devices?
Alan Evans: Pre-validated packaging is packaging that has gone through the testing required to protect your device and ensure a robust sterile barrier. This testing would absolutely be needed when validating your SBS (sterile barrier system). Pre-validated packaging configurations can come in the form of trays with Tyvek lids, Tyvek/poly pouches, header bags, poly/poly bags, etc.
Custom-developed packaging is packaging that is specifically made to fit your device. An example of custom packaging would be a tray that is made so your device “snaps” into place and secures it. Or a pouch that is specifically designed to be a certain length and width, so your device fits snug in the pouch but not too tight or too loose.
Andrew Gladd: Pre-validated packaging is packaging that has been developed and manufactured in various sizes. These are stocked currently at volume and ready for the client. These packages have gone through aging studies and are known to pass validations.
Custom-developed packages are packages that are 100% customized to the device. The demission of the pouch or tray is precise and molded around the device. These packages are likely to require new tooling to be developed. These also will have no validation history and will be at a higher risk of potentially failing validations.
Fenske: Does pre-validated packaging decrease time-to-market? If so, how?
Evans: Pre-validated packaging does decrease time to market. This is done by having performed the post-sterilization stability study for the claimed shelf life of the finished product. Our pre-validated packaging comes with a five-year shelf life. This means, from the start, you are saving 185 days in accelerated aging time in a chamber.
Gladd: Pre-validated packaging can significantly reduce your time to market, especially in a post-pandemic supply chain world. All the raw materials required to produce pouches and trays have increased in lead times by four times versus pre-pandemic. For a custom package, it can take up to six months to develop the package and to have tooling made. Once that step is completed, it can take another six months for production orders to arrive. Then you would have to perform the aging validations to claim a shelf life. In the example of five-year shelf life, it takes 185 days (about six months) to achieve a five-year claim in an accelerated chamber. All in, you can potentially save one and a half years in time.
Fenske: Can using pre-validated packaging reduce risk for orthopedic device manufacturers?
Evans: It can reduce the risk for orthopedic device manufacturers in that the pre-validated packaging is a known product. It is known the packaging will withstand the sterilization process and will act a certain way for a pre-determined number of years.
Gladd: With pre-validated packaging, there is significant data available showing the package will pass validations. This valuable history drastically decreases the risk for an orthopedic device manufacturer from the start.
Fenske: Does using pre-validated packaging limit you on packaging design and/or the options for the packaging?
Evans: In some cases, yes it can. For the most part, the pre-validated packaging is going to come in pre-determined sizes. If your device is large, it might not fit the SBS system that is being offered. If your device is very small and the smallest pre-validated SBS system is a little too big, your device might be swimming in the SBS system and has the opportunity to move around freely. A lot of pre-validated packaging was put in place to try to accommodate the most basic sizes and shapes. Great for most, disappointment for others.
Gladd: Pre-validated packaging will be offered in several sizes. These options have been researched and developed to fit the most common medical device configurations. Pre-validated packaging will not work for everyone but is a great solution for many.
Fenske: With pre-validated packaging, is the sterilization method limited to certain types or are all options available?
Evans: Sterilization modality is dependent on how the packaging was pre-validated. LSO offers packaging materials that are compatible with steam, ethylene oxide, and radiation. If the validation activities included specific types of sterilization and testing of the SBS after sterilization is complete, then you have direct evidence the sterilization modality is in compliance.
Gladd: Sterilization modality is considered during the match-making process of determining if the pre-validated packaging is the best route for a specific product. Pre-validated packaging offered by LSO has been developed for use in EO and gamma sterilization since these are the most common services used.
Fenske: What’s the impact on regulatory with pre-validated packaging? Does its use facilitate an easier process or is it unchanged?
Evans: When producing a regulatory submission, your pre-validated packaging should come with evidence that it has been validated. This evidence will become a part of the submission so, in that instance, it is easy to have that as a part of your submission. If you did not use pre-validated packaging, you would still need to provide evidence that your packaging has gone through the necessary steps to be validated. In the end, it will take time to complete your validation activities, and you are still submitting the same information.
ISO 11607 is involved and basically has three elements: material selection, design, and testing; stability activities; and sealing validation. Your pre-validated packaging should be able to help you with most of the elements of your packaging validation information in your submission or internal documentation activities.
Gladd: Pre-validated packaging offers an easier path to regulatory approval. The validation work completed is all done to thoroughly support the requirements of the ISO standards. Our pre-validated packaging offerings have gone through regulatory scrutiny previously and already passed with excellence. Going with the pre-validated packaging option removes the significant risk associated with custom-developed packaging. Using a pre-validated packaging solution essentially drops the end product into a known, proven successful environment.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
Gladd: Strongly associated with the pre-validated packaging solution is being able to support the labeling requirements of these products. LSO has a significant history in labeling requirements from having many in-stock label sizes for trays, pouches, cartons, and patient labels. This is combined with our label development expertise, UDI implementation, and many in-house printers. Many orthopedic companies will have many configurations and sizes offered. Our quality system is designed to handle hundreds of SKUs and thousands of labels for a single orthopedic manufacturer.
Offering a pre-validate packaging solution is just the start. Executing this strategy takes a talented team that has a deep knowledge of everything around the package to allow an orthopedic manufacturer to get to market quicker. Our quality system, expertise in sterilization and packaging validation, and expertise in labeling—all under one qualified roof—allow us to truly be a partner that can support this strategy.
John Nino: Employing pre-validated packaging solutions presents a low-risk, reduced-cost approach that significantly reduces time-to-market. In addition, LSO’s “off-the-shelf" pre-validated packaging is now being incorporated as part of orthopedic OEMs’ risk mitigation strategies. With cost, continuity of supply, and time-to-market being more critical than ever, utilizing LSO’s pre-validated packaging solutions presents a “path to success.” Our team of packaging experts is ready to help you overcome new and/or legacy packaging challenges you may be facing.
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