For nearly 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.
Combination Product Testing
DDL specializes in testing for the following combination products:
-Pre-filled Syringes – ISO 11040
-Needle-based Injection Systems – ISO 11608
-Vials and Cartridges
Our Expertise Includes:
-Test Method Development and Validation
-Custom Fixture Development
-Injection Force Studies and other Mechanical Tests
-Shelf-Life / Stability Studies
-ISO 11607 Packaging Validation
-Complaint Handling / Field Failures / Remediation
-Regulatory and Quality Compliance
-Particulate Identification and Analysis
-Container Closure Integrity Testing (CCIT)
In preparing for regulatory submission or verifying your products conform to the required industry standards, we provide reliable test data to document the performance and safety of your combination product.
Package Testing for Medical Devices & Pharma Products
The purpose of package testing is to ensure that packages are able to withstand the typical events associated with distribution, handling and storage without defect and loss of sterility.
Our package testing services evaluate the strength and integrity characteristics of a packaging system before and after, simulating the anticipated conditions that the system may undergo. This combination of simulation and evaluation is used to validate package compliance with ASTM, ISO, ISTA and other accepted industry standards.
DDL offers full-service package testing at its Eden Prairie, MN and Irvine, CA lab locations, and select package testing capabilities in its Edison, NJ lab.
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 storage space that have been validated for long-term and short-term shelf life studies under various temperature and humidity requirements.
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 – West
9400 Toledo Way
Irvine, CA 92618
DDL – NJ
551 Raritan Center Parkway
Edison, NJ 08837
Posted Date: 11/25/2019
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