Packaging is a crucial aspect of every finished medical device. However, custom solutions can add considerable time and costs to a project, especially if packaging decisions are delayed until later in the product development cycle. Life Science Outsourcing (LSO) offers pre-validated packaging as a cost-effective, time-saving alternative that also provides regulatory submission advantages.
Pre-validated packaging, provided by Life Science Outsourcing, has already undergone the necessary testing to protect your device and ensure a robust sterile barrier, meeting the requirements for validating your Sterile Barrier System (SBS). Examples of pre-validated packaging configurations include trays with Tyvek lids and Tyvek/poly pouches.
In contrast, custom-developed packaging is specifically designed to fit your device, such as trays that securely hold the device or pouches with precise dimensions to accommodate the device snugly.
Using LSO’s pre-validated packaging can reduce risk for orthopedic device manufacturers by providing a proven product known to withstand sterilization processes and maintain sterility for a predetermined period. The extensive data available on pre-validated packaging passing validations significantly decreases the risk from the outset.
Sterilization methods for pre-validated packaging depend on the original validation. Life Science Outsourcing offers packaging materials compatible with steam, ethylene oxide, and radiation sterilization. During the selection process, we consider the sterilization modality to determine if pre-validated packaging is the best option for a specific product. Our pre-validated packaging is developed for use in EO and gamma sterilization, the most common services utilized.
Opting for Life Science Outsourcing’s pre-validated packaging solutions offers a low-risk, cost-effective approach that significantly reduces time-to-market. LSO’s “off-the-shelf” pre-validated packaging is now being incorporated as part of orthopedic OEMs’ risk mitigation strategies. As cost, continuity of supply, and time-to-market become increasingly critical, utilizing LSO’s pre-validated packaging solutions paves the way for success. Our team of packaging experts is ready to help you tackle new and existing packaging challenges.