The Center of Excellence for Forensic Analysis is one of few dedicated service providers for particulate matter identification and root cause analysis, in pursuit of supreme quality and safety standards for biopharmaceuticals. The center has serviced over 70 integrated and 20 standalone projects by identifying a variety of particles and foreign substances and offering investigation road maps. A library has been established in the center, consisting of optical images, IR spectra and chemical properties of 76 types of particles, along with database for non-GMP and GMP container closure systems, which together allow historical data referencing and inter-comparison during investigations.
We provides systematic solutions for particulate matter identification and investigation
Specializing in the following areas
- Analyze and identify visible particles in release and stability samples
- Analyze and identify unknown contaminants in raw materials, for instance metal and colored particles
- Analyze and identify unknown particles, scratches and residues observed in production equipment and facilities
- Examine and evaluate faults and defects in production equipment and container closure systems, for instance glass shreds
- Assist examination and evaluation of unexpected events in manufacturing, for instance clogged filters, aggregation, and residual precipitates