Foreign Particles in Parenterals & Medical Devices

SPE raman. ID 5

With the fully automated SPE raman.ID 5 system you can determine the chemical composition of particles from 5 µm.at a rate of hundreds per hour. Thanks to the intuitive software control, you can obtain statistically relevant information after a short introductory training period. Simply insert the sample, select the relevant particle size and shape, then allow the system to identify the elemental distribution at a throughput rate of 100 - 600 particles per hour. Leading you quickly to the particles contamination source.

The SPE raman.ID 5 implements all the features of the SPE CSS. You receive particle count, shape, and size information about particles from 0.5 µm and above by using a particle size distribution with 8 customizable size classes. The sample is counted in just 1 - 15 minutes.

The equipment is designed to test parts cleanliness as well as identify foreign particles larger than 5 µm in medical devices and sterile pharmaceutical products such as parenterals with the use of integrated raman spectroscopy. Particle samples are collected for the raman.ID on filtr.AID patches. Analysis reports as well as all raw data are stored in a “results” file in compliance with 21 CFR Part11.

Further information available on our products Web site particle-explorer.com. The following links will take you from rap-ID.com to the particle-explorer.com Web site.