Pion Inc. announces the release of Spectra, a new instrument for fiber optic dissolution monitoring. The Spectra is a next generation instrument in the Rainbow Dynamic Dissolution Monitor® family, which is based on Pion’s patent in situ real time dissolution monitoring. The instrument builds upon Pion’s experi¬ence in the design, development and manufacture of the Rainbow and µDISS Profiler fiber optic instruments. Feedback from R&D and process control laboratories was an integral part of the development of the new instrument.

The Spectra is priced for the pharmaceutical quality control lab where multiple instruments evaluate products prior to release. The system is very easy to use by all operators in the lab, even when combined with 21 CFR Part 11 compliant IndigoSAM™ software. IndigoSAM™ also works seamlessly with the Indigo™ software used in the method development lab. Each software package is specifically designed with the needs of users in each environment, thus providing flexibility during development and security in process control.

“The new Spectra will better suit the price sensitive needs of the manufacturing market”, says Mr. Mike Kelly, President of Pion Inc. “Our suite of real-time dissolution monitoring instruments allows in situ UV fiber optic monitoring to take place across the entire drug development space, from preformulation to manufacturing. Any time a dissolution measurement is needed, from small volume to USP volumes or from testing excipients in R&D to testing in the production labs of manufacturing plants, Pion has a solution.”

While the Spectra is price competitive with on-line single or multichannel sipper based systems, it is free of the well-known problems associated with clogged filters, kinked lines and pump maintenance. The Spectra offers real time data collection and high data density which provides a much greater level of statistical confidence in the dissolution measurements. Since the fiber optic probe remains in the solution throughout the dissolution test, no operator involvement is required. Up to 8 dissolution vessels may be monitored simultaneously. Pion’s patent position in real time dissolution monitoring and Pion’s first-in–class scientific development gives users the confidence they need.