Drug and device combination product (DDCP)
Mechanical and chemical testing are needed to bring complex drug-delivery products and other combination products to market. A growing number of combination products, along with the overall growth of the pharmaceutical and biologics industry, is driving demand for a more-complex arsenal of tests
Drug and device combination product (DDCP) is merging chemical and mechanical disciplines- it is required by FDA/EMA to have both drug stability as well as the device functionality tests on the same stability program.
The demands increase for the combined mechanical and chemical testing services to demonstrate that both drug and device are stable and functional through the shelf life of the combination product. IDC with its M1075 medical device testers is providing leading edge technology in such key areas ensuring quality of end products.
These tests play an important role in determining the safety and effectiveness of combination products and are used to show that contaminants from the manufacture, fill, or seal process have not compromised the drug product.
Contact IDC for application details.