Sourcing foreign particulate matter, understanding what it is composed of and knowing where in the manufacturing process it was introduced is critical for remediation of a contamination issue in the pharmaceutical, medical device and cell/gene therapy industries. For operations that generate numerous particulates with many lots and products, digital data storage of optical information, spectral files, chemical data and important information associated with non-conforming particlesis key to an efficient particulate characterization program. This allows for mining of data, to aid in comparison to known materials, as well as to determine common lots, facilities, times, or any other information that may foster root cause analysis.

Gateway Analytical’s approach to the Particulate Characterization Database enables the user to compile, store, search and mine analytical data to optimize processes for foreign particulate and materials testing. The ability to create internal known laboratory reference collections or utilize existing commercial databases adds significant value to an investigation, and a robust data management system is critical to efficiently access the variety of materials needed to accurately identify the source of foreign materials.