What does the regulations say about particle counting in pharmaceutical solutions
European and international regulations such as USP 788, PE 2.9.19 (method 1 and method 2), AAMI TIR42… require purity control of pharmaceutical solutions and, among other things, the counting and identification of particulate contamination.
Indeed, particulate contamination poses risks to the quality of solutions and to human health. Therefore, monitoring 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 in pharmaceutical solutions
FILAB offers pharmaceutical manufacturers technical expertise and state-of-the-art analytical equipment to respond as effectively and quickly as possible to their needs (with the option of carrying out these analysis urgently) and provide them with the most suitable services and tailored support.
To address these issues with precision and reliability, FILAB offers tailored support for the counting and identification of particles in your pharmaceutical solutions, under COFRAC ISO 17025 accreditation:
We support you in
Identification of foreign bodies and/or contaminants by SEM-EDX and Binocular Micro-Infrared, in accordance with PE 2.9.52 standards
Particle counting by Optical Microscopy and image analysis, according to USP 788/789 and PE 2.9.19 (method 2)
