Drug and device combination product (DDCP)

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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.

M1075 Leak Test Instrumentation

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.


Ventilators, respirators and clinical testing machines – IDC Know-How and Application Expertise

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Pandemic related products such as ventilators, respirators and clinical testing machines must be brought to market quickly.

The requirements to assure functionality and integrity of these medical products is in many aspects quite similar to those historically faced by the automotive manufacturers who are newly entering these markets.
For example, leak-proof filtration systems are critical to both many automotive and medical parts.

If manufacturers make the wrong sourcing decisions when creating new product assembly lines for ventilators and similar, they will inevitably encumber their products with higher price tags, or create testing bottlenecks on production, or both.

Contact IDC for latest design reports on how to apply its proven testing technologies in key medical device areas.


Can comparative studies of test instruments be applied to assure that best-match leak testing technology for a specific application is being used?

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Systematic studies of leak tester technologies offered by instrument manufacturers can reveal superior best-match technology quickly, if and when gauge R&R is specified along with other test capability metrics.

InterTech Development Company now works with prospective customers to assure that a head-to-head comparison of InterTech leak testers is made with instruments from 3 or more other global market leaders in leak test technology.

Criteria of specific targets for decreasing test cycle time while maintaining gauge R&R are specified.

Contact IDC for the latest design report on the latest comparative studies based on application requirements.