Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in test methods for both Porous (ASTM F1929-12) and Nonporous (ASTM F3039-13) packaging. ASTM F1929 – 12 Standard Test Method for […]
As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects. When a project reaches me, often times the packaging has already been created and procured for the device(s) by the client. For an alarming ratio of these designs I am able to identify very […]
Theoretically, even though the tax will have a major negative initial impact on Medical Device companies, it will end up generating more business, due to the increased patient population having access to healthcare, and having procedures which require the use of medical devices. However, that is not likely to happen.
At LSO, we typically manage 50-55 new product launches a year. This doesn’t include helping existing customers with product revisions and follow on work. This is a launch rate that far surpasses that of many multi-billion dollar medical device companies. Our volume is driven by our focus on the start-up market and our willingness to […]
The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device. The primary standard governing medical device packaging and shelf life validation is ISO 11607-1
Distribution Simulation Testing assesses a medical package’s ability to protect and maintain sterility of the products within. This is accomplished by exposing the package to real-life hazardous conditions that it could face through the handling, distribution and storage stages of its journey. The package/container and its contents are subjected to a test plan involving shock, […]
Packaging for Medical devices, related products and materials is highly regulated and must meet very specific requirements. The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device.