Chapter 2.9.19. of the European Pharmacopoeia relates to the control of non-visible particulate contamination. These new local requirements allow the test to be performed on volumes less than 5 mL.
This analytical method is used to check the purity of a pharmaceutical injectable solution, or on the surface of medical devices and equipment.
The FILAB laboratory, expert in particulate contamination counting according to method 2 of EP 2.9.19.
FILAB is COFRAC ISO 17025 accredited for particle counting analysis of medical devices and pharmaceutical solutions according to method 2 of EP 2.9.19
FILAB offers manufacturers specializing in the medical and pharmaceutical sectors 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 tailor-made support for particle counts according to method 2 of EP 2.9.19, but also for other reference systems…
On pharmaceutical products:
- The 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 PE 2.9.19 (method 2)
On medical devices:
- Particle Counting by Optical Microscope according to current standards: ISO 19227, ISO 10993-19, USP 788, PE 2.9.19, AAMI TIR 42
- Particle identification by SEM-EDX and µ-IRTF according to the current standards: ISO 10993-19, PE 2.9.52, PE 2.2. 24, AAMI TIR 42
