Laboratory analysis of foreign bodies
Are you looking to analyze foreign bodies detected in your products or formulations?
What are foreign bodies?
A foreign body is a substance or particle that is not expected to be present in a sample and that may affect its composition, properties, or purity. Foreign bodies can come from a variety of sources and are often considered contaminants that can alter the results of an analysis or affect the quality of the product being studied.
Sources of foreign bodies
Throughout the manufacturing process, there are many sources of contamination that can lead to the appearance of a foreign body in pharmaceutical products. Foreign bodies can be of several types, i.e. organic, mineral or metallic.
Why perform a foreign body analysis?
The presence of foreign bodies in a drug can impair its performance (disintegration, dissolution) and pose a health risk to the patient.
Accurately identifying the nature and origin of these particles is therefore essential to assess quality impacts, secure production, and adapt industrial processes accordingly.
These contaminants or foreign bodies, often invisible to the naked eye, can measure from a few micrometers to nanometers, requiring the use of high-precision analytical techniques such as electron microscopy (SEM-EDX), infrared spectroscopy (FTIR), or X-ray diffraction (XRD) for reliable characterization.
FILAB supports manufacturers in the identification and investigation of foreign bodies in their products
Pourquoi faire appel à FILAB pour vos analyses de corps étrangers ?
FILAB propose aux industriels pharmaceutiques des compétences humaines de haut niveau et un parc analytique de pointe afin de leur offrir des services répondant à leur critère de conformité dans le respect des normes règlementaires pour tout type de médicament et forme galénique.
Afin de répondre avec rapidité et fiabilité à ces problématiques, FILAB propose un accompagnement sur-mesure pour l’identification et l’analyse de corps étranger.
Our foreign body analysis services
Search for traces of a specific component (packaging, cleaning residues, equipment, etc.)
Detection of impurities (ICH Q3D)
Help creating a defect library
Our technical resources to determine the presence of foreign bodies
Application case: identification and analysis of foreign bodies in pharmaceutical products
FAQ
Foreign bodies can cause interruptions in production processes, defects in finished products, and deviations from quality and safety standards. They can cause premature wear of equipment, require frequent overhauls of production lines, and increase manufacturing costs due to the need to repeat tests, reject contaminated batches, or initiate product recalls.
Sample traceability plays a crucial role in foreign body management, as it allows the complete history of a sample to be tracked, from collection to analysis. This includes recording all handling, processing, and storage conditions, making it easier to identify potential stages where contamination could have occurred and allowing for specific corrections to be made to the affected processes.
The combination of techniques such as scanning electron microscopy (SEM-EDX), infrared spectrometry (FTIR) and X-ray diffraction (XRD) makes it possible to identify the chemical composition of particles, whether organic, mineral or metallic.
Companies can minimize the risk of foreign body contamination by adopting an integrated approach to quality management that encompasses careful selection of raw materials, control of production processes, implementation of good manufacturing practices (GMP), regular monitoring of the production environment to detect potential sources of contamination, and ongoing training of personnel on proper handling and hygiene practices.
A foreign body can be organic (textile fibers, plant residues), mineral (silica, calcium carbonate), or metallic (stainless steel particles, aluminum). These contaminations can come from raw materials, wear and tear on production equipment, or even the manufacturing environment (dust, packaging).
Once the nature of the contaminant has been identified, the investigation goes back to the potential sources: raw materials, production environment, equipment or packaging, by cross-referencing analytical data with industrial processes.
Using scanning microscopy and microanalysis techniques, it is possible to identify particles smaller than 10 microns, which is crucial for injectable or ophthalmic solutions.
Visible particles are detectable to the naked eye (> 50 µm) while sub-visible particles require optical or electronic detection techniques (between 1 and 50 µm). Both types of contamination require characterization to assess their impact on quality and safety.
