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Pre-Validated Packaging for Medical Devices

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]

Gloved hands holding a sterile medical device in clear packaging.

Visual Inspection Testing
for 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.

Gloved hands holding a sterile medical device in clear packaging.

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.

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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?

OEMs

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.

  • Time and cost efficiency: Save significant resources with packaging that has already been tested and validated.
  • Consistency and reliability: Maintain sterility and ensure product integrity with proven solutions.
  • Regulatory compliance: Meet stringent standards and minimize non-compliance risks.
  • Risk reduction: Reduce the likelihood of product recalls and patient safety issues.

Engineers

For engineers, pre-validated packaging offers a practical solution to complex challenges in device development.

  • Simplified design process: Skip lengthy custom packaging design cycles with ready-to-use options.
  • Reliable performance: Access validated solutions that meet sterility and durability standards, freeing up time to focus on device innovation.
  • Regulatory alignment: Pre-validated packaging supports compliance with ISO 11607 and FDA requirements, reducing the need for extensive validation documentation.

Procurement Professionals

Procurement teams in OEMs find value in pre-validated packaging by minimizing supply chain risks and managing budgets effectively.

  • Cost savings: Save hundreds of thousands of dollars by avoiding custom design and validation costs.
  • Streamlined sourcing: Pre-validated solutions eliminate the need to coordinate with multiple suppliers for packaging development.
  • Reduced lead times: Accelerate time-to-market by up to 12 months with off-the-shelf solutions ready for immediate integration.

Quality Assurance Specialists

Quality assurance professionals benefit from pre-validated packaging by enhancing product reliability and ensuring compliance with industry standards.

  • Reduced testing requirements: Leverage proven packaging solutions that meet sterilization and barrier property standards.
  • Minimized risk of defects: Avoid potential failures in packaging design with pre-tested and validated options.
  • Regulatory readiness: Simplify audits and inspections with pre-validated solutions backed by complete documentation.

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.

Technician wearing protective gear closely examining medical device packaging for leaks during a dye test in a laboratory setting.
A laboratory technician in cleanroom attire conducts a quality control inspection with a clipboard and pen in a sterile facility.

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.

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