DDL Minnesota
10200 Valley View Road
Eden Prairie, MN 55344
United States (US)
T: (952) 941-9226
F: (952) 941-9318

DDL – MN GMP
5407 Opportunity Court
Minnetonka, MN 55343
United States (US)
T: (952) 941-9226
F: (952) 941-9318

DDL California
9400 Toledo Way
Irvine, CA 92618
United States (US)
T: (714) 979-1712
F: (714) 979-1721

DDL – New Jersey
551 Raritan Center Parkway
Edison, NJ 08837
T: (732) 346-9200
F: (732) 346-0295
E: ddlinforequests@ddltesting.com
W: https://www.ddltesting.com

 

For over 35 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.

 

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. DDL now also offers package testing in its GMP Laboratory located in Minnetonka, MN.

Drug Delivery Device Testing

DDL specializes in mechanical and performance testing for pre-filled syringes (ISO 11040), needle-based injection systems (ISO 11608) and small-bore connectors (ISO 80369). 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 drug delivery product.

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.

Stability Storage

DDL’s testing laboratories contain over 80,000 cubic feet of storage space that have been mapped and calibrated for long- and short-term shelf life studies under various temperature and humidity requirements. DDL has the conditions you need and the capacity to support your tight timelines. Custom storage conditions and reports are available to support your specific procedures.

Industrial CT Scanning

From dimensional inspection of small-bore connectors to first article inspections on assemblies, DDL utilizes custom fixtures and programming to meet the measurement needs of various types of medical device parts. We leverage our equipment to run inspections on parts to ensure assemblies do not have defects, evaluate porosity and ensure additive manufactured parts do not have voids or issues given their design / purpose. Each project is unique and will be evaluated upon request.