Your needs: carry out the identification and particle counting of contaminants
At FILAB laboratory, particle counting plays a key role in identifying and quantifying contaminants in liquids, components, or materials.
What is particle count analysis?
Particle counting is essential for quality control and contamination prevention in demanding sectors such as pharmaceuticals and microelectronics. This analysis allows for the detection and characterization of specific particles, thus meeting strict standards and industrial requirements in terms of safety and performance.
FILAB offers customized solutions for analyzing contaminants and particles.
Supported matrices
Particle counting and particle identification can be carried out in a variety of matrices depending on industrial needs and the sectors concerned.
- Pharmaceutical solutions: injectable medicines, vaccines, serums.
- Water: ultrapure water for microelectronics, purified water used in pharmaceuticals.
- Cosmetics: Lotions, creams or gels containing liquid phases.
- Cleanroom air: control of airborne particles to ensure the cleanliness of sterile environments.
- Industrial gases: monitoring the purity of gases used in manufacturing processes, such as microelectronics or chemicals.
- Pharmaceutical powders: active ingredients, excipients or powder mixtures.
- Industrial materials: debris on surfaces or resulting from mechanical wear.
- Particles on medical devices: analysis of particles deposited on implants, syringes or other equipment.
- Composite products: polymers, alloys or coating materials.
Our solutions: FILAB carries out particle counting to quantify and identify the particles in your products
Why choose FILAB for the identification and particle counting of contaminants?
As a laboratory specialising in deposit and pollution analysis, we carry out particle count analysis to qualitatively and quantitatively assess the contaminants present in your products. Our advanced technology can detect a range of impurities, from dust to micro-organisms, ensuring that your products meet the highest quality and safety standards.
Particle counting in compliance with standards and regulations
Compliance with standards and regulations is essential to ensure the reliability of particle counting analyses. The application of standardized methods ensures compliance with the requirements of industrial sectors, particularly pharmaceutical and medical:
- European Pharmacopoeia (2.9.19)
- ISO 16232
- ISO 8536
- ISO 19227
- Guide FD E01-007 August 2012
- USP 788-789
- ASTM F24
- AAMI TIR42:2010
- OECD 125
FILAB remains at your disposal to study the feasibility of any identification and/or particle counting standards applicable to your products.
Services / Contaminants identified during a particle count analysis for the pharmaceutical and medical industry
With the appropriate analytical techniques (Optical & Electron Microscopy, FTIR-Microscopy, Image Analysis), FILAB is able to analyze, count, detect and identify very small quantities of contaminants of very small sizes in many products and matrices of any kind (organic, inorganic and metallic)
Learn more
What types of contaminants can be identified during a particulate contamination analysis?
Why perform a particulate analysis of contaminants?
Services / Counting and identification
Particle counting
Particle counting is an analytical technique used to quantify and characterize the presence of particles in a sample, be it a liquid or gaseous medium, or the raw materials used in production processes.
Particle counting measures the size, shape and distribution of particles, and provides valuable data for understanding the processes at play in the systems under study. The particle counting process involves the use of particle counters that detect and count particles, often expressed in micrometres.
Particles identification
Combining particle counting with detailed identification is essential for guaranteeing control of production environments and product quality in demanding industries.
Counting quantifies the number and size of particles, while identification reveals their nature (metallic, organic, inert) and origin (equipment wear, packaging, environment). This combined approach makes it possible to prevent contamination, resolve critical problems (batch rejections, technical failures) and comply with strict standards.
Contaminants identified by particle counting
- Metal particles: from wear and tear on machinery, important in the mechanical industries.
- Dust and debris: from materials processing, affecting the finish of products.
- Combustion particles: derived from combustion processes, typical in welding operations.
- Chemical particles: residues of manufacturing chemicals, requiring control to avoid contamination.
Inert particles: Dust and other residues that can cause cross-contamination between products.
Fibres and equipment: From clothing, packaging materials or the wear and tear of medical devices, which can contaminate medicines during packaging.
These analysis require high sensitivity to detect and quantify contaminants, in order to maintain product safety and integrity in highly regulated environments.
Our training courses
Our FAQ
FAQ
Particle count analysis quantifies how many particles are present in a sample. Particle size analysis measures the dimensional distribution of those particles. FILAB frequently performs both analyses together to give clients a complete contamination profile: quantity, size range, morphology and chemical identity.
For pharmaceutical applications, FILAB applies USP 788 (particulate matter in injections), EP 2.9.19 and JP 6.07. For medical devices, we follow ISO 19227 and AAMI TIR42. All methods are performed under our quality management system and, where applicable, within our COFRAC ISO 17025 accreditation scope.
Yes. For sub-micron and nano-scale particles, FILAB uses Dynamic Light Scattering (DLS), Single Particle ICP-MS (SP ICP-MS) and Transmission Electron Microscopy (TEM). These techniques cover the 1 nm to 1000 nm range, making them ideal for nanomaterial characterisation, colloidal stability studies and nanoparticle contamination investigations.
Sample preparation depends on the matrix. Liquids are typically filtered through membrane filters (0.45 µm or 0.22 µm) and the filter is examined by microscopy. Solids may be suspended in an appropriate solvent and sonicated before analysis. FILAB provides detailed sampling guidelines with every quotation to ensure representative results.
FAQ - Pharmaceuticals and particle counting
Particle counting is an analytical method used to detect, identify, and quantify particles present in pharmaceutical samples. It helps ensure compliance with standards, particularly for injectable solutions or liquids used in production.
Samples include injectable solutions, rinsing fluids, liquid excipients, pharmaceutical oils, and water used in manufacturing. These analyses aim to prevent the risk of contamination of equipment and patients.
The laboratory uses specific techniques such as optical microscopy, filtration and spectroscopy to identify and count particles in pharmaceutical oils, complying with international pharmaceutical standards such as the pharmacopoeia.
Yes, for injectable products or liquids in contact with mucous membranes, international pharmaceutical standards (USP, EP) impose precise thresholds of particles by volume.
FAQ - Cosmetics and particle counting
Particle size is used to assess the stability of cosmetic formulations such as creams or serums. A consistent particle size ensures a pleasant texture, increased effectiveness, and reduces the risk of contamination.
The results of particle analysis laboratories are crucial in the cosmetics industry, mainly to guarantee the quality, safety and performance of products.
FAQ - Medical devices and particle counting
Particle counting makes it possible to detect and eliminate residual particles from the manufacturing processes (machining, cleaning, packaging) of medical devices.
ISO 19227 requires the control and limitation of particulate contamination of medical devices to ensure their cleanliness and safety. It provides specific methodologies for the measurement, identification and quantification of residual particles, including particle counting and chemical analysis, in order to comply with defined thresholds for implantable and non-implantable devices.
