Pre-validated medical packaging can shorten your project timeline by as much as a year and save hundreds of thousands in costs by eliminating the need for design and production, and simplifying the validation processes. [needs work JN]
Pre-validated packaging streamlines your project timeline and reduces costs by eliminating the need for custom design, production, and validation processes. At Life Science Outsourcing, our pre-validated solutions are already tested for sterility, barrier properties, and regulatory compliance, offering a reliable, ready-to-use packaging option. This approach minimizes risks, enhances supply chain efficiency, and accelerates your path to market—ensuring your devices are protected and meet the highest standards.
Pre-validated packaging is a packaging system that has already undergone and passed various validation tests such as sterilization compatibility, barrier properties, material compatibility, and shelf life stability.
By completing the necessary testing to protect your device and establish a robust sterile barrier, pre-validated packaging meets the requirements for validating your sterile barrier system (SBS). Examples of pre-validated packaging configurations include trays with Tyvek lids and Tyvek/poly pouches.
Pre-validated packaging not only saves time and resources but also mitigates risks to your supply chain by offering a ready-to-use solution that avoids delays or complications often associated with custom validation processes.
In contrast, custom-developed packaging is specifically designed with precise dimensions to fit your device, which may include trays or pouches, but often adds design and production costs and extends your timeline.
Pre-validated packaging accelerates your time-to-market by up to 12 months and can save you up to 30% in development costs, all while minimizing supply chain risks.
Medical device manufacturers, contract sterilization providers, and healthcare providers and institutions can benefit from this packaging solution in various ways:
Medical device manufacturers, contract sterilization providers, and healthcare providers and institutions can benefit from this packaging solution in various ways:
Time and cost efficiency
Pre-validated packaging saves significant time and resources in the development process, as the packaging has already been tested and validated.
Consistency and reliability
Pre-validated packaging is a consistent and reliable solution to maintain medical device sterility.
Regulatory compliance
Pre-validated packaging helps to meet regulatory requirements and reduce non-compliance risk.
Risk reduction
Pre-validated packaging reduces product recall risks and potential patient safety issues related to package failures.
Reducing risk for orthopedic device manufacturers
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 risk from the outset.
Sterilization method compatibility
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 EtO and gamma sterilization, the most common services utilized.
Medical device manufacturers benefit from pre-validated packaging by streamlining production and meeting market demands faster. Pre-validated solutions reduce development timelines, lower costs, and offer a proven sterile barrier system, making it an ideal choice for bringing products to market efficiently.
For engineers, pre-validated packaging offers a practical solution to complex challenges in device development.
Procurement teams in OEMs find value in pre-validated packaging by minimizing supply chain risks and managing budgets effectively.
Quality assurance professionals benefit from pre-validated packaging by enhancing product reliability and ensuring compliance with industry standards.
Enter the dimensions of your medical device below and our calculator will check to see which pre-validated packaging options will fit your device.
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Packaging is a crucial aspect of every finished medical device. Pre-validated packaging is ready to use off-the-shelf and eliminates many of the custom package processing steps.
Life Science Outsourcing offers pre-validated medical device packaging as a cost-effective, time-saving alternative that also provides regulatory submission advantages. Our team will help you to determine if pre-validated packaging is the right solution for your device.
Pre-validated packaging helps OEMs demonstrate that their packaging system can maintain device sterility according to key regulations:
21 CFR Part 820
Quality system regulation (QSR) includes requirements for design controls, including packaging validation.
ISO 11607
ISO 11607 is the internation standard that specifies packaging material, preformed sterile barrier systems, and packaging systems requirements.
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 risk mitigation strategies for orthopedic OEMs.
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.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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