A number of inspectional observations from various Regulatory Authorities related to visible and subvisible particles in pharmaceuticals has risen considerable concern. Manufacturers of pharmaceutical and medical device products have to demonstrate that they have implemented all possible appropriate investigations to determine the identity and origin of any contamination that may occur.
The presence of particulate contamination, or foreign particles, in sterile pharmaceutical products and/or medical device can affect their safety and efficacy. Foreign particles may originate from both organic and inorganic sources, as corroded or damaged equipment parts, cross contamination during the process, microplastics or from biological sources.
The implementation of quality controls for particles can be a good strategy in order to minimize the contamination probability.
Mérieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentations combined with a pool of experts in different fields.
OUR CAPABILITIES ON FOREIGN PARTICLE IDENTIFICATION IN PHARMACEUTICAL PRODUCTS
Microscopic examination for visible and sub-visible particles.
The technique allows a first evaluation of sample and the information acquisition in order to decide eventual further microbiologic analyses. In some cases, it permits the identification of the foreign particles.
The association between SEM (Scanning Electron Microscope) and EDS (Energy Dispersive Spectrometry) allows to carry out microanalyses on small organic and inorganic particles. State of the art instruments allows to perform non-destructive analysis.
TEM (Transmission Electron Microscope - maximum potential magnification of 1 nanometre) and EDS (Energy Dispersive Spectrometry) allows to extend the investigation to nanoparticles and relative aggregates/agglomerates.
FT-IR microscopy and µFT-IR/Chemical Imaging
FT-IR microscopy allows to carry out spot FT-IR analysis on small particles above 0,1mm and is suitable for both organic and inorganic materials.
µ-FT-IR/Chemical Imaging technology is the golden standard to detect and identify microparticles and microplastics of dimension between 10 µm and 1 mm.
Additional tools available
LC-HRMS is an additional tool available within Mérieux NutriSciences that could assist in the identification of organic solvent soluble particles in some cases.
Download the Foreign Particles flyer
- Typical construction materials in pharmaceutical and medical device manufacturing plants as source of particles
- Effective cleaning procedures
- Pre-treatment of equipment/product contact utilities
- Inspection of equipment before and after production
- Cleaning after repairs
- Essential written procedures covering maintenance and cleaning procedures
- Environmental conditions during open handling in final stages of pharmaceutical and medical device manufacturing
- Effective training of operators