Eden Prairie, MN 55344
Experts for medical device and pharma testing. DDL has provided package, product and materials testing for the medical device, pharmaceutical, and consumer goods industry since 1990.
Package Testing DDL’s package testing services evaluate the strength and integrity of packaging systems before and after simulating the anticipated distribution and storage conditions that the systems may undergo. Packaging professionals use this combination of simulation and evaluation to validate package compliance with ASTM, ISO, ISTA and other accepted industry standards. DDL offers full service package testing in Eden Prairie, MN and Irvine, CA, and select package testing capabilities in Edison, NJ.Materials TestingMaterial properties testing is a critical step in understanding how your materials will perform or react under a wide variety of stresses. DDL’s material testing services include: coefficient of friction, flexural bend testing, film testing, fatigue testing, polyurethane foam testing, shear testing, Sutherland rub test, puncture & impact testing, peel adhesive testing, tear testing, and tensile testing.Medical Device and Combination Product Testing DDL specializes in testing medical devices and combination products such as luer fittings (ISO 80369), syringes (ISO 7886) pre-filled syringes (ISO 11040), needle-based injection systems (ISO 11608), needles (ISO 7864 & 9626), catheters (ISO 10555), guidewires (ISO 11070), infusion sets (ISO 8536), surgical sutures. DDL also provides vibration, physical shock, thermal shock, friction, flow rate, force to operate, leakage and compression testing. Custom test development and protocol creation are also available.Stability Storage
DDL provides stability storage space for products requiring environmental conditions based on ICH Q1A guidelines as well as customizable storage conditions. Our facilities contain over 38,000 cubic feet of validated storage space for long-term and short-term shelf life studies under various temperature and humidity requirements.Container Closure Integrity Testing
Package integrity verification requires careful examination of package leakage given the specific product and its life cycle. DDL’s CCI services include both the most recent deterministic capabilities, as well as probabilistic methods, as outlined in USP . We can provide tailored expertise to design and execute a CCI study based on your system, providing the support you need.
Who We Are
DDL is a full-service ISO/IEC 17025:2017 accredited testing lab that provides packaging, materials, medical device and combination products testing to the medical device, pharmaceutical, biotech and consumer products markets. DDL’s team of engineers, technical and quality experts is devoted to helping customers worldwide succeed by taking an independent, involved and informed approach to ensuring regulatory compliance. DDL’s commitment to customer service is supported by an upfront approach, unmatched technical expertise, a robust quality system, fast turn-around, and scalable capacity. All of our testing services are delivered with integrity, professionalism and a commitment to meeting the timing needs of our customers.