Pre-validated packaging
Pre-validated medical device packaging can save up to 12 months in package design, production, and validation processes. Check if your device fits with our custom calculator feature.
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.
Visual Inspection Testingfor Medical Device Packaging Integrity
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.
What is pre-validated packaging?
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.
Why Choose Pre-Validated Packaging?
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.
Who needs pre-validated packaging?
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.
Who needs pre-validated packaging?
Will it Fit? Calculator
Enter the dimensions of your medical device below and our calculator will check to see which pre-validated packaging options will fit your device.
How does pre-validated packaging work?
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.
What standards apply?
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.
Why LSO?
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.
Full EtO Validation
Comprehensive packages for regulatory compliance.
Flexible Sterilization Cycles
From fractional to full cycles with EtO residual testing.
Robust Qualification
Secure with 2X qualification.
Choice of PCDs
Tailored to your sterilization needs.
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
Ready to get started?
Talk to a specialist about pre-validated packaging.