The Applied Technical Services Family of Companies (ATS FoC) conducts medical device packaging testing for manufacturers seeking to evaluate packaging systems that protect devices during handling, transportation, and storage. Effective packaging helps maintain product integrity and supports sterile barrier performance when required.
ATS offers laboratory-based medical device packaging testing for manufacturers, developers, and other organizations in our ISO 9001:2015-registered, ISO/IEC 17025:2017-accredited testing laboratories.. These evaluations help identify weaknesses in packaging materials, seals, and complete systems.
Packaging is critical in the medical device supply chain, facing vibration, compression, impacts, temperature changes, and other environmental factors. Testing enables organizations to assess packaging performance under these conditions.
What Does Medical Device Packaging Testing Evaluate?
Medical device packaging testing assesses characteristics based on the device, packaging configuration, and intended use. Evaluations may address materials, seals, sterile barriers, and distribution performance. Common evaluations may include:
- Package integrity testing
- Seal strength testing
- Dye penetration testing
- Bubble leak testing
- Visual inspection
- Accelerated aging studies
- Environmental conditioning
- Distribution simulation
- Vibration testing
- Compression testing
- Impact and drop testing
- Package material characterization
The test program should be tailored to the packaging system and its intended application. ATS assists organizations in selecting tests that meet project objectives and requirements.
Who Needs Medical Device Packaging Testing Services?
Medical device manufacturers use packaging testing during product development and production. Packaging suppliers and contract manufacturers also require testing to evaluate systems and components. Organizations that may benefit from these services include:
- Medical device manufacturers
- Pharmaceutical and combination-product manufacturers
- Packaging manufacturers
- Contract manufacturers
- Medical device developers
- Quality assurance teams
- Research and development organizations
- Regulatory and compliance teams
Testing is conducted during initial package development, after changes to materials, equipment, or processes, and as part of ongoing quality programs.
How Can Medical Device Packaging Testing Support Product Development?
Packaging testing provides objective data on package performance under defined conditions, helping development teams identify areas for improvement.For example, testing may reveal changes in seal strength or package integrity after environmental conditioning. Distribution testing offers insight into packaging response during simulated shipping.
These evaluations inform decisions on materials, sealing processes, and configurations, and assist in investigating unexpected packaging failures. Testing should align with the intended use of the packaging system. Laboratories help establish evaluation plans based on device, design, and testing requirements.
What Medical Device Packaging Tests Does ATS Provide?
ATS provides laboratory testing for a range of medical device packaging evaluations. Available services depend on the packaging system and project requirements. Potential testing areas include:
- Sterile barrier system evaluations
- Package seal testing
- Package integrity evaluations
- Distribution testing
- Environmental conditioning
- Accelerated aging
- Material testing
- Transportation simulation
ATS evaluates individual packaging components or complete systems as needed. Testing programs are structured around project objectives and established methods.
Why Should Medical Device Manufacturers Test Packaging Systems?
Medical device packaging must protect devices during handling and storage. Packaging failures may impact product condition, sterility, or usability. Testing provides manufacturers with performance data, helping identify weaknesses before products are distributed.
Packaging testing supports quality investigations of unexpected defects. Comparative testing helps teams evaluate materials, designs, or manufacturing conditions. A documented testing program contributes to informed packaging development and provides technical data for quality and engineering activities.
When Should Medical Device Packaging Testing Be Performed?
Manufacturers conduct packaging testing at various stages of a product’s lifecycle. Early testing helps identify design considerations before production. Additional evaluations are appropriate after significant changes to materials or processes. Testing also supports shelf-life studies, transportation evaluations, and investigations. Common situations include:
- New medical device development
- New packaging system development
- Packaging design changes
- Material changes
- Manufacturing process changes
- Supplier changes
- Shelf-life evaluations
- Distribution qualification
- Quality investigations
Medical Device Packaging Testing at Applied Technical Services
ATS offers medical device packaging testing for organizations needing laboratory support during development, qualification, and evaluation. These capabilities help manufacturers gather technical data on packaging performance under defined conditions.
A well-planned testing program provides valuable information on package integrity, material performance, and distribution durability. ATS collaborates with clients to define testing objectives and select appropriate laboratory evaluations. ATS helps clients determine an evaluation approach based on specific packaging configurations, devices, and project requirements. Contact us to discuss your testing needs and available laboratory capabilities.
Contact Us
For accurate medical device packaging testing with results your business can depend on, contact the professionals at ATS by submitting a web request form or calling +1 (888) 287-5227 today.
