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Particle counting laboratory according to USP 788
The U.S. Pharmacopeia regulates the counting of particulate contamination: non-visible particles
USP 788 defines particulate matter as undissolved mobile particles, other than gas bubbles, unintentionally present in solutions.
USP 788 determines allowable limits of non-visible particulate matter in parenteral formulations, particularly ready-to-use solutions for intramuscular, subcutaneous or intravenous injection.
FILAB laboratory, expert in particulate contamination counting according to USP 788
FILAB is COFRAC ISO 17025 accredited for particle counting analyses on Medical Devices and Equipment according to ISO 19227 and USP 788.
For more information: www.cofrac.fr
FILAB offers manufacturers specializing in the manufacture of medical devices technical skills and state-of-the-art analytical equipment in order to respond to their requests in the best possible way and in a reactive manner (possibility of carrying out these analyses in an emergency) and to provide them with the most appropriate services and a tailor-made follow-up.
In order to respond accurately and reliably to these issues, FILAB offers tailor-made support for particle identification in your medical devices according to USP788, PE 2.9.19, AAMI TIR42, etc.
The FILAB laboratory assists companies of all sectors and sizes in solving their industrial problems. We put at your disposal the know-how and experience of our team of PhD students and engineers.
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²