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 companies and manufacturers of injectable delivery systems in performing particulate matter counting analysis compliant with USP <788>, European Pharmacopoeia 2.9.19 and associated standards.
The United States Pharmacopeia regulates particle contamination counting: invisible particles
What does USP 788 say?
The USP <788> “Particulate Matter in Injections” defines the requirements for controlling subvisible particles present in injectable solutions and parenteral infusions.
This regulation requires:
- counting particles ≥10 µm and ≥25 µm,
- maximum allowable limits,
- standardized analytical methods,
- acceptance criteria based on the injectable volume.
Particulate matter counting limits according to USP <788>
Small Volume Injections (SVI)
- ≤ 6,000 particles ≥10 µm
- ≤ 600 particles ≥25 µm
Large Volume Injections (LVI)
- ≤ 25 particles/mL ≥10 µm
- ≤ 3 particles/mL ≥25 µm
FILAB is COFRAC ISO 17025 accredited for particulate counting analysis of Medical Devices and Medical Equipment in accordance with ISO 19227 and USP 788.
The FILAB laboratory, expert in particle contamination counting according to USP 788
USP Particle Counting & Complementary Particle Identification
Particle counting measures the number of particles within the size ranges defined by the applicable compendial reference. Identifying their chemical nature is a complementary investigation: SEM-EDX and µ-FTIR help trace the source of contamination without replacing the prescribed particle-counting method.
USP 789 particle counting: the case of ophthalmic solutions
Are you looking for a USP 789 testing laboratory for an ophthalmic solution?
Chapter USP <789> covers the enumeration of subvisible particles in ophthalmic solutions. Its scope and criteria must be distinguished from those of USP <788> for injectable preparations.
USP 789 expertise begins with qualifying the product and the applicable standard:
- nature of the solution,
- intended use, presentation
- and available volume.
The counting protocol, size classes, and acceptance criteria are defined based on these factors; they are not inferred from the USP 788 thresholds.
Why perform USP <788> particulate matter counting?
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 <788> 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 of particles in your medical devices by scanning electron microscopy (SEM)
Analysis of your medical devices by infrared microscopy (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.
