Fiber optic dissolution testing offers you a fast and cost-effective method for determining the rate of release of a drug product over time.
With over 21 years of industry leadership, Pion’s fiber optic technology delivers benchmark performance and reliability. Our powerful analytical instruments and 21 CFR Part 11 compliant software measure concentration and percent dissolved data in real time and are widely trusted in quality control labs, both for accuracy and efficiency.
Why Fiber optics?
In-situ real time fiber optics hold many advantages over traditional methods that involve sampling, fluidics/sample handling, and offline analysis. In-situ Benefits:
• No filtration
• No pumping
• No sampling
• Dissolution profile with frequent data points (as quickly as every 5 seconds)
• Real-time dissolution curve for every channel, up to 8 channels
Integration - Working with your dissolution bath
• Compatible vessel covers are available (off-the-shelf or custom) whenever the bath design allows the integration
• Multiple probe designs are available (straight or J-style; fixed or variable pathlength) to optimize the data collection
• Broad pathlength range (1-20 mm) is available to fit the system to the desired concentration range
Documentation – fitting into your compliant environment
• Clear definition of features/functions relating to 21 CFR Part 11 are provided in the design specifications and functional specifications documents developed with a computer system validation specialist.
• Software and hardware qualification is provided through detailed IQ/OQ/PV protocols.
Contact us today to learn more about how our Rainbow UV-vis fiber optic probe concentration monitor can be an essential part of your QC Dissolution setup.
