The company’s laser particle detection system allows accurate real-time counting, sizing, and data logging of shed particles from each drug-eluting stent during testing, giving a time course of shed particulates from each sample. The large number of samples greatly benefits manufacturing QA when ongoing testing of approved stents is required.
The company claims that Coating Durability Tester include the ability to test samples of varying sizes of the same design at the same precisely-controlled test parameters. The universal controller allows the user to control and monitor the frequency, temperature, and pressure and provides the ability to establish, maintain, and recall required test parameters.
In addition, a closed loop laser micrometer feedback allows for automatic control and monitoring of long-term test parameters. User-controlled alarms ensure that the proper testing conditions are maintained throughout the test. Future upgrades with advanced Scada technology allow complete lab monitoring of all machines from a single host computer. Data provided by the CDT20 complies with USP < 788 > and all pertinent AAMI/ISO and ASTM standards.