Before you set out to validate a medical device package design or process, you’ve got to do your homework in order to understand what is critical to build the proper foundation for a sterile barrier system and to avoid a breach of that system. Scott Levy, senior packaging engineer for DDL, offers the following 10 […]
DDL, Inc. is celebrating its 25th anniversary of providing package, product and material testing to the medical device industry.
DDL was founded in 1990 by John Hart and Patrick Nolan. Hart and Nolan had previously worked for Eden Prairie based testing products supplier MTS Systems. The two started DDL (originally called Distribution Dynamic Labs) when an […]
DDL is now offering test method validation (TMV) services to medical device manufacturers and developers.
Test method validation is the documented process of ensuring a test method is suitable for its intended use. It involves establishing the performance characteristics and limitations of a method and the identification of influences which may change those characteristics.
“TMV is a […]
DDL has expanded capacity for medical device package testing at its laboratories in Fountain Valley, CA and Eden Prairie, MN.
The expansion includes the addition of more chambers at its recently opened facility at the Fountain Valley laboratory to provide increased capacity for environmental conditioning, real time aging and accelerated aging testing. Additional chamber capacity has […]
When DDL purchased Citech in 2010, it took on the challenge of learning the methodology to perform electrosurgical accessory testing under the guidance of Citech’s founder and president, Robert Mosenkis. Citech’s primary area of expertise was in the performance testing of the insulation that protects patients and practitioners from the high voltage electrical signals used […]
DDL is pleased to announced its Eden Prairie, MN and Fountain Valley, CA facilities have received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA).
ISO/IEC 17025:2005 is the international standard by which a laboratory’s commitment to quality and technical competence are evaluated. DDL achieved ISO/IEC 17025:2005 accreditation by demonstrating its laboratories are in […]
DDL is now able to provide testing for subcutaneous implanted ports in accordance with the newly added Part 6 of the ISO 10555 series of test standards. Part 6 standardizes the test methods for subcutaneous implanted ports. DDL’s capabilities include leakage, tensile and needle penetration as covered in Annex A, C, D and E of […]
The use of pre-filled glass syringes is becoming more and more prevalent as the preferred delivery device for drugs and vaccines. Pre-filled syringes are a more efficient, reliable and convenient method for drug administration helping to reduce drug waste and dosage errors while also improving safety.
A number of testing standards have been developed for the […]
Test method validation (TMV) is the documented process of ensuring a test method is suitable for its intended use. It involves establishing the performance characteristics and limitations of a method and the identification of influences which may change those characteristics. The experimental results are subjected to statistical analysis and a series of pre-defined acceptance criteria […]
ASTM F1929 “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration” is a dye penetration integrity test used by package engineers that is designed to detect and locate leaks caused by channels formed between a transparent film and a porous material.
The ASTM F1929 standard was first written in 1998, was […]