Copley Scientific has launched a new software package for cascade impactor management and data analysis called “Inhalytix,” which succeeds the company’s long-established CITDAS cascade impactor software. The new software, which is 21 CFR Part 11 compliant, can be used with a variety of cascade impactors, including the NGI, the Andersen impactor, and the Fast Screening Andersen impactor. Users can choose to have the software based in the cloud, on a server, or on individual computers, and data can be entered manually or imported.
According to Copley, Inhalytix “handles the entry, analysis and reporting of APSD data to company and regulatory standards, in accordance with draft USP Chapter <1603>, Ph.Eur. Chapter 2.9.18 and relevant US FDA guidance. The software also serves as a database for laboratory cascade impactor inventory enhancing data traceability and integrity.” Inhalytix uses the same calculation protocols as CITDAS and adds the ability to calculate new metrics, including impactor sized mass, large particle mass, and small particle mass, the company said.
In addition to new metrics, Inhalytix includes tools for comparing results that can be useful for comparison of test and reference products when developing a generic OINDP. The equipment database also allows for the use of actual impactor dimensions for calculations instead of nominal dimensions by associating mensuration data with individual impactors.
Copley recently announced a number of upgrades to its OINDP testing range.
Read the Copley Scientific press release.
