Particle counting laboratory — USP 788 testing & analysis
You would like to carry out a specific count according to USP 788
The United States Pharmacopoeia regulates the counting of particulate contamination: non-visible particles
What Is USP 788?
USP 788 defines particulate matter as undissolved mobile particles, other than gas bubbles, unintentionally present in solutions.
USP 788 establishes the permissible limits for non-visible particles in parenteral formulations, specifically 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 analysis on Medical Devices and Equipment according to ISO 19227 and USP 788.
The U.S. Pharmacopeia regulates the counting of particulate contamination: non-visible particles
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 analysis 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.
FAQ
It’s a standard procedure to measure subvisible particulate matter in injectable drug and device components, using established compendial methods: light obscuration (Method 1) and microscopic counting (Method 2).
Only particles ≥ 10 µm and ≥ 25 µm are counted and compared to USP limits, which may be expressed per mL or per container depending on volume.
