European and international regulations such as USP 788, PE 2.9.19, AAMI TIR42… require the control of the purity of pharmaceutical solutions and among others the counting and identification of particulate contamination.
Particulate contamination presents risks for the quality of solutions and for human health; therefore, controlling the presence or absence of particulate contaminants and/or determining a level of particulate contamination is one of the key steps in a process for pharmaceutical manufacturers.
FILAB is COFRAC ISO 17025 accredited for particle counting analysis of pharmaceutical solutions
FILAB offers pharmaceutical manufacturers technical skills and state-of-the-art analytical equipment in order to respond to their requests in the best possible way (possibility of carrying out these analysis in an emergency) and to provide them with the most appropriate services and tailor-made follow-up.
In order to respond accurately and reliably to these problems, FILAB offers customised support for counting and identifying particles in your pharmaceutical solutions, under COFRAC ISO 17025 accreditation:
We accompany you in
Identification of foreign bodies and/or contaminants by SEM-EDX and Binocular Micro-Infrared, according to PE 2.9.52 and PE 2.2.54
Particle counting by Optical Microscopy and Image Analyzer, according to USP 788/789 and EP 2.9.19 (method 2)
Download now our White Paper “Particle Analysis and Identification in Injectable Products”.
