Foreign Particles in Parenterals & Medical Devices

SPE raman.ID + metal.ID 5

The SPE raman. ID + metal. ID 5 determines chemical elements as well as chemical structure information using Raman Spectroscopy for particles ranging from 5 µm and larger at a rate of thousands per hour. For the first time, two orthogonal spectroscopy technologies can identify unknown particle material. The intuitive software obtains statistically relevant information after only a short introductory training period. Simply insert the sample, select the relevant particle shape and size parameters, and then allow the fully automated system to identify the exact chemical composition and elemental distribution at a throughput rate of 300-6000 particles per hour.

An integrated spectra library is available for metallic elements and several alloy materials. The integrated database search software can identify particle spectra and metallic material. All the raw data including raw images, analyzed images, particle morphology, particle stitch merging, and spectra are then stored in a “results” file in compliance with 21 CFR.

The equipment is designed to identify contaminants 5 µm and larger in medical and pharmaceutical devices using integrated LIBS (metal.ID) Spectroscopy. Particle Samples are collected on a filter membrane e.g. filtr.AID or Cellulose Nitate patch.