Eurofins ensures combination drug, device & delivery systems meet regulatory and patient safety requirements

Ashley Harger, Consulting Operations Strategist, Eurofins Medical Device Services

The biopharmaceutical industry has delivered an increasing number of biologics to the market with advances in the development of targeted treatments, effective engineering processes, and positive impacts on patients.

While needle-free injection devices are being explored as alternative delivery methods, the use of pre-filled syringes, manual injector pens, and auto-injectors remain as the most reliable administration methods, allowing patients the option for self-injection.

Efficacy of pre-filled syringes, manual injector pens, and auto-injectors is established with suitable functional testing to demonstrate reliable delivery of the drug to the patient. The convenience of self-injection means that the delivery device will be managed by the patient themselves through everyday life, being handled much more than products that are administered in a clinic or hospital setting.

Throughout both the device and packaging design, it is critical to evaluate the function under stressed conditions.

Functionality tests are performed at various stages of the product life cycle to establish confidence in the design of the device and the packaging to verify that the device and packaging can protect the drug and delivery device so it will remain effective for patient use.

Early phase testing also evaluates consistency in manufacturing with critical measurements or dimensions of the needle or other components of the device. Eurofins conducts testing that includes dimension analysis.

For biological extracts, recombinant products, vaccines, cell and gene therapies, Eurofins supports testing beyond the analysis of the therapeutic. Our Medical Device Package Testing team supports studies for Design Verification of the delivery device as well as the packing, including all layers of packaging - all the way to the outermost layer, and with transit testing.

To conclusively evaluate the design prior to initiation of the manufacturing and packaging processes, transit testing, along with package integrity testing, barcode and label verification, and functional testing of the device provide confidence in the design of both the device and the packaging.

For these combination products, a typical design verification study will evaluate for temperature excursions followed by testing that demonstrates sterility, either with microbiological testing or container closure integrity testing. Additional exposure of product is simulated with drop or vibration of individual units, followed by functional tests to demonstrate accurate dose delivery.

Support for shelf-life studies also demonstrates product efficacy throughout the product expiration by comparison of real-time aging with accelerated aging conditions. Eurofins offers a variety of aging conditions to perform shelf-life studies.

Eurofins is a leader in testing combination products with more than a decade of experience. By integrating container closure integrity studies with device functionality evaluations, Eurofins generates combined evidence, demonstrating sterility, stability, and usability under storage, aging, and distribution to safeguard both drug and device performance. This dual approach anticipates the expectations of regulators, who increasingly view container closure and device packaging as interdependent elements of patient safety.

In addition to technical testing, Eurofins supports regulatory and post-market needs. Consultants collaborate to design packaging validation plans aligned with ISO, ASTM, ISTA, FDA, and EMA expectations, building evidence strategies that withstand review. Post-market, Eurofins assists with packaging changes, safety labeling updates, shelf-life extensions, and MDR compliance activities, supporting continued packaging effectiveness and compliance throughout the product lifecycle.

For more information visit: www.Eurofins.com/BPT or: Contact Us to submit an inquiry.