10200 Valley View Road
Eden Prairie, MN 55344
T: (952) 941-9226
F: (952) 941-9318
9400 Toledo Way
Irvine, CA 92618
T: (714) 979-1712
F: (714) 979-1721
DDL New Jersey
551 Raritan Center Parkway
Edison, NJ 08837
For over 30 years, DDL has provided extraordinary service and specialized testing expertise to the medical device and pharmaceutical industries. Our reliable quality, responsive attention, and on-schedule completion for packaging, medical device, and combination products testing secures confidence in performance and safety while achieving regulatory compliance.
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.
Combination Product Testing
DDL specializes in mechanical and performance testing for pre-filled syringes (ISO 11040) and needle-based injection systems (ISO 11608). In preparing for regulatory submission or verifying your products conform to the required industry standards, DDL provides reliable test data to document the performance and safety of your combination product.
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 <1207>. We can provide tailored expertise to design and execute a CCI study based on your system, providing the support you need.
Medical Device Testing
DDL specializes in testing medical devices such as luer fittings, syringes, needles, catheters, guidewires, surgical sutures, cannulae and tracheal tubes. DDL tests to ANSI, ASTM, IEC, ISO, JIS, EN and other industry standards. Vibration, physical shock, thermal shock, friction, flow rate, force to operate, leakage and compression testing are among the many tests provided. Custom test development and protocol creation are also available.
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.
Posted Date: 12/3/2020
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