In the last number of years, visible foreign particulate matter, FPM, became the number one reason for recalls in the pharmaceutical industry. Therefore the attention and demands of the authorities has increased, with a special focus on root cause investigation of the particle contamination. Compendial chapters have been changed and specified accordingly. FDA inspectors like to see the staged investigation cycle approach.
rap.ID has established training programs in the US and in Europe to train the life cycle as well as the investigation stages. In our laboratories we follow this approach and we also provide services on USP <1790> and USP <790>. rap.ID develops methods and aids in implementing a defect library of visible investigation rejects supported by means of micro imaging.
FDA and other authorities demand for a thorough investigation on particulate contamination. Within hours rap.ID´s particulate matter experts provide you with a reliable comprehensible CMC report on the Foreign Particulate Matter visible reject. Subvisible particle identification down to 2 µm by means of micro Raman and micro LIBS can reveal systemic contamination issues in your pharmaceutical filling environment and processes and differentiate from single incidents.
From the documentation of the particulate, prior to opening the container, to the comparison of spectra from your reference samples with the particulate´s spectroscopic signature, rap.ID documents and delivers GMP compliant information on all necessary steps and information for your particle contamination root cause investigation.
Micro-photographic images of your particle without opening the container, therby preserving the samples integrity:
Depending on the results from Raman and LIBS the particle will be further characterized by ATR and FTIR. rap.ID has IR libraries with 10,000 entries to match unknown contaminants and previously unidentified mixtures.
Depending on the results from Raman and LIBS the particulate can be additionally characterized by our Scanning Electron Microscope with the Electron Diffraction Spectroscopy unit. This works great for metallic and inorganic particles, and heterogeneous particle materials such as a rubber stopper.