Before being available in pharmacies or hospitals, each new product undergoes a lengthy process consisting of various clinical tests designed to prove both its efficacy and safety. Once a drug is on the market, its quality is also subject to numerous controls throughout its production and life cycle. From the arrival of raw materials to post-marketing stability control, numerous protocols and analytical methods are implemented to guarantee product compliance and to gain more in-depth knowledge by tracking the slightest variations.
It is in this context that one of the largest players in the pharmaceutical industry has requested our laboratory to conduct a study to identify particles observed in an injectable solution after aging under severe conditions.
Potentially explained by an interaction between the injectable solution and the packaging, the observed particles were the object of a general diagnosis in order to identify their chemical nature. The tools used in this context were: Scanning Electron Microscopy (SEM-FEG-EDX), Infrared Spectroscopy (FTIR), … The hypothesis of a degradation with one of the elements of the packaging having been validated thanks to the results obtained, our laboratory then proposed to this industrialist and implemented a complete study with the objective of reproducing the defect under different conditions in order to better understand the mechanism. The benefits of this methodological work allowed us to suggest changes in the nature of the packaging element at the origin of the particles and then to validate one of the proposed solutions by requesting the new configuration under the same severe aging conditions.
Thanks to the human skills and the analytical means available in its laboratory, but also to its strength of proposal, FILAB was able to accompany this industrialist beyond his initial need of characterization by proposing innovative solutions aiming at solving durably the encountered problem.
FILAB has significant experience in the implementation of these high-stakes expertises and can assist you with your needs for expertise related to the problems associated with interactions.
For more information, contact our expert: contact@filab.fr
