Identification and particle counting of contaminants
Your needs: performing the identification and particle counting of contaminants
Particle counting is essential for quality control and contamination prevention in demanding sectors such as pharmaceuticals and microelectronics. This analysis makes it possible to detect and characterize certain particles, thereby meeting strict standards and industrial requirements for safety and performance.
FILAB offers you tailor-made solutions to analyze contaminants and particles.
Supported matrices
Particle counting and particle identification can be carried out in various matrices depending on industrial needs and the sectors concerned.
- Pharmaceutical solutions : injectable drugs, vaccines, serums.
- Water : ultrapure water for microelectronics, purified water used in pharmaceuticals.
- Cosmetic products : lotions, creams or gels containing liquid phases.
- Cleanroom air : monitoring airborne particles to ensure the cleanliness of sterile environments.
- Industrial gases : monitoring the purity of gases used in manufacturing processes, such as in microelectronics or chemistry.
- Pharmaceutical powders : active ingredients, excipients, or powder blends.
- Industrial materials : debris on surfaces or 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 performs particle counting to quantify and identify particles in your products
Why choose FILAB for the identification and particle counting of contaminants?
As a laboratory specialized in deposit and pollution analysis, we carry out particle counting analysis and particulate contamination analysis to qualitatively and quantitatively assess the contaminants present in your products.
Our advanced technology makes it possible to detect various impurities, from dust to microorganisms, 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 count analyses particle counting. The use 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
- FD E01-007 Guide August 2012
- USP 788-789
- ASTM F24
- AAMI TIR42
- OECD 125
FILAB remains at your disposal to assess the feasibility of any identification and/or particle counting standards applicable to your products.
Services / Contaminants identified during particle counting
Our analysis for the pharmaceutical and medical industries
Our technical resources
Using appropriate analytical techniques (Optical & Electron Microscopy, FTIR Microscopy, image analyzer, etc.), FILAB is able to analyze, count, detect, and identify particulate contaminants in very small quantities and at very small sizes in many products and matrices, whatever their nature (organic, inorganic, mineral, metallic).
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What types of contaminants can be identified during a particulate contamination analysis?
Why carry out particulate contaminant analysis?
Services / counting and identification
- Particulate counting
Particulate counting is an analytical technique used to quantify and characterize the presence of particles in a sample, whether in a liquid or gaseous medium, or in the raw materials used in production processes.
Particle counting makes it possible to measure particle size, shape, and distribution, and provides valuable data for understanding the processes at work in the systems studied. The particulate counting process involves the use of particle counters that detect and count particles, often expressed in micrometers.
- Particle identification
Combining particulate counting with detailed identification is essential to ensure 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 helps prevent contamination, solve critical issues (batch rejections, technical failures), and comply with strict standards.
Contaminants identified during particulate counting
Particulate counting makes it possible to control contamination and ensure product quality. As a particulate counting laboratory, we frequently monitor certain types of contaminants:
- Metal particles: resulting from machine wear, important in mechanical industries.
- Dust and debris: generated by material processing, affecting product finish.
- 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.
- Fibers and equipment: originating from clothing, packaging materials, or wear 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 other analytical services
Our FAQ
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, rinse fluids, liquid excipients, pharmaceutical oils, and water used in manufacturing. These analysis are intended to prevent contamination risks for equipment and patients.
The laboratory uses specific techniques such as optical microscopy, filtration, and spectroscopy to identify and count particles in pharmaceutical oils, in compliance 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 particle limits per volume.
FAQ - cosmetics and particle counting
Particle size makes it possible to assess the stability of cosmetic formulations such as creams or serums. A homogeneous particle size ensures a pleasant texture, improved effectiveness, and reduces contamination risks.
The results from particle analysis laboratories are crucial in the cosmetics industry, mainly to ensure product quality, safety, and performance.
FAQ - medical devices and particle counting
Particle counting makes it possible to detect and remove residual particles resulting from manufacturing processes (machining, cleaning, packaging) in medical devices.
ISO 19227 requires the control and limitation of particulate contamination in medical devices to ensure their cleanliness and safety. It sets out specific methodologies for measuring, identifying, and quantifying residual particles, notably through particle counting and chemical analysis, in order to comply with defined thresholds for implantable and non-implantable devices.