Particle counting laboratory — USP 788 testing & analysis
You would like to carry out a specific count according to USP 788
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.
USP 788 outlines two main testing procedures. Method 1 uses Light Obscuration, which is the preferred primary test for most clear liquid formulations. Method 2 involves Microscopic Evaluation, which is utilized when a product cannot be tested by Method 1 (for example, highly viscous liquids, emulsions, or solutions that produce air bubbles). Our USP 788 testing laboratory is fully equipped to perform precise particle counting by Optical Microscope (OM) filtration.
Yes, the USP 788 standard is widely harmonized with other major pharmacopoeias to ensure global safety. It is technically closely aligned with the European Pharmacopoeia (Ph. Eur. / PE 2.9.19). FILAB offers tailor-made support for particle counting and identification in your medical devices according to both USP 788 and PE 2.9.19, as well as guidelines like AAMI TIR42.
If a medical device or parenteral solution exceeds the allowable limits for subvisible particles, it is critical to investigate the root cause of the contamination. This is where a specialized laboratory brings true value. FILAB goes beyond simple counting: we extract the particles and identify their chemical nature using Scanning Electron Microscopy (SEM) and infrared microscopy (FTIR) to help you pinpoint the source of the contamination (e.g., manufacturing environment, packaging, or raw materials).
USP 788 testing is mandatory for parenteral preparations, including ready-to-use solutions for intramuscular, subcutaneous, or intravenous injection. It is also highly critical for medical devices that feature fluid pathways or come into direct contact with the vascular system, such as IV infusion sets, implantable devices, syringes, and catheters, to ensure patient safety from subvisible particulate matter.
