Your needs: ensuring quality control of your vaccines and injectable pharmaceutical products
Vaccines and other injectable pharmaceutical products (drugs administered by infusion) are subject to special attention when it comes to production quality. The aim is therefore to guarantee safety throughout the manufacturing process.
From formulation to filling, including filtration and sterilization, the production quality issues for vaccines and injectables vary depending on the manufacturing environment.
Thus, one of the quality issues is to check for the absence of particles in vaccines and injectable products, particularly abnormal endogenous particles (such as glass particles).
Visual inspection of liquid forms and other lyophilized products is mandatory, but not very strictly regulated. As a result, over the course of their experience, pharmaceutical manufacturers have developed real expertise to make up for this gap. They therefore rely on mirage solutions (manual mirage, semi-automatic mirage or automatic mirage). The purpose of this visual inspection step is to ensure the products are of good quality at the macroscopic level.
During inspections, pharmaceutical manufacturers are generally increasingly challenged on mirage, but also on identification and the origin of visible particles or sub-visible particles.
Where can these particles in vaccines come from?
There are several types of particle sources in vaccines and injectable pharmaceutical products:
- The manufacturing process and the materials used
for metallic particles (stainless steels INOX 316 / 316 L…), plastic and polymer materials (infusion bags), elastomers (seals, rubber…) - Packaging components
Interactions between glass (syringes) and the ingredients in injectable pharmaceutical formulations can lead to the release of glass particles.
Why identify particles in vaccines and injectable medicines?
Several cases may arise:
- When the particles are not visible to the naked eye… but can be detected using mirage techniques
- When the particles visible to the naked eye cannot be identified by the person carrying out the visual inspection (manual mirage)
Our solutions: identifying particles in vaccines and other injectable solutions?
our services
La Microscopie Electronique à Balayage couplée à une sonde EDX (MEB-EDX) permet d’identifier les particules inorganiques ou métalliques
The ICP technique (ICP/AES and ICP/MS) makes it possible to identify and quantify trace inorganic particles, regardless of the type of vaccine or injectable
La Microscopie Optique couplée à l’Infrarouge (µ-FTIR) permet d’identifier les particules inorganiques ou métalliques
Separation analytical techniques such asGC-MS or LC-MS make it possible to identify and quantify trace organic particles
