Laboratory analysis of foreign bodies found in pharmaceutical products
Are you looking to analyze foreign bodies found in your pharmaceutical products ?
Throughout the production process, there are very many possible sources of contaminants which could lead to the apparition of a foreign bodies in a medication. They can be of various natures, they can be organic, inorganic and even metallic.
Their presence can have a negative impact on the performance of a medication or could even be toxic to the patient. Due to this, the identification of foreign bodies and the adaptation of production processes is paramount.
Identifying a foreign body requires the use of high-performance analytical tools due to the fact that these bodies are often invisible to the naked eye and that the size of one of these bodies can vary from a few micrometers down to a few nanometers.
FILAB is able to assist pharmaceutical industrialists in identifying and investigating foreign bodies found in medications
FILAB offers pharmaceutical industrialists a high level of technical skill and a cutting-edge analytical fleet to provide them with services fulfilling their criteria for product compliance and adhesion to regulatory standards for all kinds of medications.
To quickly and reliably solve these problems, FILAB provides tailored support for the identification and analysis of foreign bodies :
- Characterization by SEM FEG EDX, FTIR, GC-MS, Optical Microscopy…
- Detection of trace amounts of specific components (packaging, cleaning residue…)
- Purity testing on pharmaceutical products
- Detection of impurities (ICH Q3D)
- Particulate and contaminant analysis
- Assistance in creating a register of defects
- Procedural audits
Our technical facilities :
- Organic analysis : GCMS, Py-GCMS, LC-MSMS, GPC, NMR, FTIR
- Mineral analysis : ICP, XRD, IC
- Thermal analysis : TGA, DSC
- Powder analysis : XRD, SEM-FEG EDX, BET
- Surface analysis : SEM-FEG EDX, PES, ToF-SIMS
