Particulate Analysis
Particulate analysis is the practice of imaging, identifying, and quantifying particles that have shed from a product or are contaminating a product. Particulates can significantly impact the quality, safety, and performance of products across various industries.
At Lucideon, we leverage our extensive expertise and analytical capabilities to offer a rapid and accurate service across a range of applications and industries. Our team utilizes advanced techniques to detect, characterize, and measure particulate matter for a wide range of product types.
Lucideon’s particulate analysis services can support your regulatory approval journey as well as identify and resolve issues related to unexpected contaminants. Our analytical capabilities can help identify and quantify particles for your medical device, pharmaceutical product, automotive component, aerospace material, and more.
Applications of particulate analysis
- Release of coatings from products
- Orthopaedic wear debris characterization (e.g. ISO 17853, ASTM F1877)
- Medical device shedding (e.g. stents, catheters)
- Particulate shedding from bearings
- Air foil shedding
- Unexpected contaminants on formulated products, metals, polymers, and ceramics
- Additive manufacturing debris
- Particulate contamination in fuel, lubricants, and hydraulic fluids
Analytical techniques
- Optical microscopy
- Keyence microscope
- DLS (dynamic light scattering)
- SEM/EDX (scanning electron microscopy with energy dispersive x-ray spectroscopy)
- FEG-SEM (field emission gun - scanning electron microscopy)
- FTIR (fourier transform infrared analysis)
- ToF-SIMS (time-of-flight secondary ion mass spectrometry)
- Electron microprobe
Extraction techniques
- Ultrasonication
- Filtration
- Simulated use
- Harvesting from a variety of materials e.g., liquids, metals, plastics
- Epoxy resin captures
Rapid Processing
When you have production on hold, or product in quarantine, time is critical. Lucideon can save you time with immediate priority access to world-class expertise and particulate analysis that will help you to solve the issue.
Our focus on analysis and evaluation suits a consultative approach, allowing us to go the extra mile for our clients. Using this information problems can be resolved at their cause, reducing waste, and saving both resources and time.
Certified Experience
We have extensive experience working with pharmaceutical manufacturers, medical device manufacturers, contract research organizations (CROs), and quality control and regulatory compliance laboratories.
In the UK, Lucideon is a UKAS-accredited testing laboratory (No. 0013) and our Pharmaceutical/GMP Laboratories hold an MHRA Certificate of GMP Compliance (No. UK GMP 43644 Insp GMP/IMP 43644/34927202-0002, dated 29/02/2024) for contract QC Testing of Human and Veterinary Medicines. The Lucideon Pharmaceutical/GMP Laboratories also hold a current FDA Certificate of Registration and were successfully inspected by the FDA in September 2019.
In the USA, Lucideon is an ISO 17025, Nadcap, and 10 CFR 50 Appendix B accredited testing laboratory. We also maintain a GE Transportation and Aviation Special Process Certification to perform many S-400 test codes.