Particle counting laboratory — USP 788 testing & analysis
International pharmacopoeias require the control of subvisible particles in injectable preparations to ensure patient safety and the regulatory compliance of pharmaceutical products.
FILAB supports pharmaceutical manufacturers and manufacturers of injectable delivery systems in carrying out particle count analysis in compliance with USP <788>, the European Pharmacopoeia 2.9.19, and related standards.
The United States Pharmacopeia regulates particle contamination counting: invisible particles
Que dit l'USP 788 ?
L’USP <788> « Particulate Matter in Injections » définit les exigences relatives au contrôle des particules subvisibles présentes dans les solutions injectables et perfusions parentérales.
Cette réglementation impose :
- le comptage des particules ≥10 µm et ≥25 µm,
- des seuils maximaux admissibles,
- des méthodes analytiques normalisées,
- des critères d’acceptation selon le volume injectable.
Particle Count Limits According to USP <788>
Small Volume Injections (SVI)
- ≤ 6000 particles ≥10 µm
- ≤ 600 particles ≥25 µm
Large Volume Injections (LVI)
- ≤ 25 particles/mL ≥10 µm
- ≤ 3 particles/mL ≥25 µm
FILAB est accrédité COFRAC ISO 17025 pour les analyses de comptage particulaire sur les Dispositifs et les Equipements Médicaux selon la norme ISO 19227 et l’USP 788.
The FILAB laboratory, expert in particle contamination counting according to USP 788
Why perform USP <788> particulate testing?
Particle counting makes it possible to:
ensure batch release,
investigate contamination,
control primary packaging,
secure injectable products,
qualify a cleaning process,
evaluate an injectable delivery system.
Particulate contamination can have several sources. It can be generated by polymer materials or elastomers used in packaging and delivery systems. Particles can also come from glass, particularly during filling or container handling steps. Manufacturing processes, aseptic filling operations, and industrial equipment are also potential sources of particulate contamination in injectable products.
Why choose FILAB for your USP analysis?
FILAB supports pharmaceutical manufacturers with:
- COFRAC ISO 17025 accreditation,
- expertise in particulate contamination,
- counting and identification capabilities,
- state-of-the-art analytical equipment,
- complex contamination investigations,
- analysis with short turnaround times.
our related services
Identification des particules dans vos dispositifs médicaux par microscopie électronique à balayage (MEB)
Analyse de vos dispositifs médicaux par microscopie infrarouge (IRTF)
Particle extraction from medical devices
Particle counting by filtration using an Optical Microscope (OM)
Our FAQ
USP <788> covers subvisible particles, while USP <790> addresses visible particles in injectables.
The two standards are similar but have certain methodological and interpretative differences.
Indirectly, yes, especially for injectable delivery systems and combination products.
Metallic, polymeric, silicate particles, fibers, organic residues, process contaminants, glass, elastomers…
To get a quote, you can contact our teams via our contact form, by phone, or by email.
All you need to do is send us your requirements (material type, desired analysis, any applicable standard, urgency, number of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Lead times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your constraints and industrial urgencies.
