Qualifying packaging to transport biological samples and pharmaceutical materials is vital, as there is often little room for error in time and expense. As we see more personalized and other advanced medicines go from clinical trials to market, the expectations for packaging grow more precise and complex.
It’s no surprise, then, to see estimates of the global pharmaceutical packaging industry increasing by over 30% by 2028. Integral to the success of new packaging solutions is comprehensive testing to meet government and company-specific requirements.
Qualification testing
A package is exposed to many external forces while in transit, including temperature, pressure, humidity and light. Comprehensive qualification testing provides assurance that the material being transported remains unaffected within a certain time range.
Medical device and packaging manufacturers adopted a qualification framework from the computer science industry. Commonly referred to as DQ/IQ/OQ/PQ, these qualification tests ensure that a packaging solution will perform as expected along a specific transport route.
Though these qualification tests run standard across the advanced packaging industry, there is often confusion between these and other related terms (ie packaging validation, which begins with the manufacturer). We break down qualification testing terminology here:
- Design Qualification (DQ): This step ensures that all people, systems, and equipment identified in relation to a packaging solution are appropriate and comprehensive.
- Installation Qualification (IQ): This step tests that all equipment involved in qualification testing is set up properly, according to manufacturer, and that all parts are accounted for.
- Operational Qualification (OQ): Once installation qualification is verified, the next step is to ensure that the equipment and systems operate effectively for the specific test purpose. This step ensures that the expectations of the systems and equipment correspond to the testing outcomes.
- Performance Qualification (PQ): Finally, the people, systems and equipment must be tested in real-world scenarios to ensure consistency and reliability throughout the process.
Verification at each level of testing must be met before moving to the next set of procedures. If not, adjustments may need to be made in the testing procedures or equipment.
Comprehensive planning before testing
Qualification testing is a scientific and rigorous process, and as such, requires a detailed plan before testing can begin. The plan should be developed based on knowledge of an organizations processes, materials, systems and stakeholders.
Additionally, many regulatory bodies have testing requirements and best practices, but all qualification plans should include the following details:
- A test plan: Each packaging solution and it's accompanying systems should have a detailed procedures document, often in a flow chart format.
- Sample size: As with any experimentation, defining the number of units tested is important to achieve the desired level of assurance.
- Frequency of tests: How often packaging is tested depends on many factors, including what the packaging is intended to store and the length of transit.
- Method justification: Anyone should be able to read the qualification plan and understand why decisions were made and how they comply with regulations.
- Aging conditions: Packaging and systems may have limited lifespans, thus should be tested for repeated use and storage.
- Acceptance criteria: This establishes the level of risk or error that will prevent a test from being passed.
Supporting healthcare packaging needs
Effective quality testing requires time, planning and financial resources, but is essential for compliance, efficiency and patient safety. The process can be difficult to navigate, especially for researchers and developers working at the forefront of new medical treatments.
Fortunately, some third-party logistics providers offer in-house qualification planning and testing.
Biocair supports the life science industry by providing fully qualified and pre-conditioned packaging. Our dedicated packaging and logistics experts provide comprehensive solutions to deliver advanced medicines, including cell and gene therapies.
Learn more about packaging testing for cell and gene therapies in our latest Insight.
Based in North Carolina, Robert oversees all packaging validation and qualification processes for cold chain products utilized by global operations and the dedicated call and gene therapy team. His primary focus is to identify new technologies within the cold chain product space and onboard them through the development of custom protocols and procedures. His work, along with the aid of his team, provides a higher peace of mind for clients that turn to Biocair for advanced packaging solutions.
