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 […]
At the heart of ASTM F1980 “Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices” are the Arrhenius equation and Accelerated Aging Factor (AAF) Determination (Sections 6 and 7). Practical use of the AAF involves choosing an aging factor (Q10) which is typically a value of two (2) for packaging testing, an […]
ASTM D4169-09 recently has been revised to D4169-14. ASTM D169 is the test method performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments.
ASTM D169 is the standard that has been used extensively in the medical device industry, as it is […]
Medical device packaging is almost as important as the device itself. Packaging for medical devices plays a key role in safely delivering specialized treatment to patients. Most single use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation.
What makes medical device packaging […]
Many medical device manufacturers (MDMs) struggle with the development of a packaging system design qualification test plan for compliance to ISO 11607. ISO 11607 requires that sterile medical device package systems be capable of withstanding the transportation and distribution environment. This is typically accomplished by performing a package performance test protocol consisting of a series […]
When labeling a product, ensuring that you are using the best combination of materials to present the product as intended to the end user and while reducinge costs as much as possible are major considerations. There are a seemingly unlimited number of different types of label materials and inks both with different properties. When it […]
Each time you package a medical device for sale and delivery, your design – and its execution – get put to the test. Ultimately, companies that package and ship medical devices are responsible for the health and safety of patients worldwide. Your products and procedures will be under the microscope, and failing these tests can […]
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 […]
As the “Just-in-Time” mentality has become more pervasive within the medical device industry, it has also resulted in many more package validation testing projects being rushed and left to the last minute.
While the “Just-in-Time” mentality is here to stay, it is also important to realize that this “Just-in-Time” mentality can pose a significant risk of […]