This specialized case study explores Kymanox’s approach to custom test fixture development through integrated pressure control systems and real-time data acquisition. Our team of Subject Matter Experts (SMEs) collaborated closely with pharmaceutical device stakeholders to implement measurable improvements across back pressure testing capabilities, precision mass measurement, user interface design, and safety features for drug delivery device characterization and validation.
CHALLENGE
SOLUTION
RESULTS
- Pharmaceutical client required custom back-pressure chamber development for comprehensive testing of drug delivery devices with adjustable back pressure capabilities simulating physiological conditions.
- Real-time mass delivery data measurement essential as fluid dispensed onto precision laboratory balance enabling accurate characterization of delivery profiles.
- Fixture design needed meeting stringent safety and usability requirements including easy disassembly, routine maintenance access, and operator protection features.
- Integrated data capture and analysis capabilities required supporting efficient testing workflows and comprehensive documentation for regulatory submissions and development activities.
- Designed comprehensive mechanical layout integrating pressure vessel, electronics systems, pneumatics, and intuitive graphical User Interface (UI) ensuring seamless operation.
- Specified and procured precision laboratory balance along with various off-the-shelf and custom machined components optimizing performance and cost-effectiveness.
- Developed Windows-compatible software application enabling real-time data capture, ad hoc pressure adjustments, and comprehensive back-pressure parameter control.
- Engineered safety features into pressure vessel preventing over-pressurization hazards and ensuring safe disassembly procedures protecting operators.
- Implemented user-friendly maintenance features including replaceable septum and accessible component design facilitating routine servicing and calibration.
- Successfully delivered functional test fixture capable of dynamically adjusting back pressure while recording and graphically displaying mass delivery data in real-time.
- Enabled direct data output to Microsoft Excel format facilitating easy analysis, reporting, and integration with existing documentation workflows.
- Ensured user-friendly operation with both manual and software-driven adjustments for back pressure control providing testing flexibility.
- Incorporated comprehensive safety features and maintenance-friendly design including replaceable septum and accessible components supporting long-term reliable operation.
- Established versatile testing platform supporting drug delivery device characterization, formulation development, and regulatory validation activities.