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What is particle counting?
Particle counting is an analytical technique used to quantify and characterise 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.
What is the purpose of counting particulate contaminants?
Particle counting of contaminants is essential for many industries, as it enables the quality of the production environment and finished products to be controlled.
In the pharmaceutical sector, for example, accurate counting ensures the purity of powders and medicines, where the presence of micro-organisms or unexpected particles can pose serious health risks to patients.
In the microelectronics industry, even tiny particles of dust or metallic debris can cause failure problems in integrated circuits, leading to yield losses and high costs.
So particle counting of contaminants is essential to improve the overall quality of industrial processes while ensuring product safety for consumers, as well as complying with regulations.
Particulate contaminants: identification and counting
Particle counting helps to control contamination and guarantee product quality. As a particle counting laboratory, we frequently monitor certain types of contaminants:
Industrial sector :
– 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.
Pharmaceutical sector :
– 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 solution: FILAB laboratory qualitatively and quantitively analyzes particulate contaminants found in your products
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.
Our services for the pharmaceutical and medical industries
Our technical resources
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)
Analysis of particulate contaminants according to the standards
Particle counting in compliance with standards and regulations
In addition to the technical aspect, the regulatory and standards aspect is also an important factor in guaranteeing the reliability of the analysis carried out, particularly in terms of counting particulate contaminants, using known and appropriate methods. Here are a few examples (non-exhaustive list):
- 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
- OCDE 125
FILAB remains at your disposal to study the feasibility of any identification and/or particle counting standards applicable to your products.
Particle counting in the pharmaceutical industry
Particle counting is a crucial stage in the drug manufacturing process in the pharmaceutical industry. It involves measuring the number of particles present in a product, and identifying them, in order to ensure the safety and quality of the medicine.
Particle counting is carried out using sophisticated and precise instruments, such as laser particle counters. These instruments allow rigorous control of raw materials, excipients and the final product.
They also enable particulate contaminants to be accurately identified and counted. In the pharmaceutical industry, particulate contaminants can take different forms, such as fibres, organic or mineral particles, and can cause harmful effects. Thanks to these analysis, manufacturers are able to determine the source of contaminants and implement preventive measures to ensure risk-free production.
Why FILAB?
As an independent laboratory with a team made up of highly qualified personnel, FILAB guarantees the reliability of its results, a quick turnaround for requests and tailored support for clients.
FAQ
Particle counting is an analytical method used to detect, identify and quantify particles present in pharmaceutical samples. It is used to guarantee 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 analyses are designed 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, in compliance with international pharmaceutical standards such as the pharmacopoeia.
As a laboratory specialising in chemical analysis and characterisation, FILAB has access to state-of-the-art equipment such as :
- Scanning electron microscopy (SEM) for precise particle identification.
- Infrared spectroscopy to characterise the chemical nature of particles.
Particle size is used to assess the stability of cosmetic formulations such as creams and serums. Homogeneous particle size ensures a pleasant texture, increased efficacy and reduces the risk of contamination.
Laboratories can identify metallic, organic or inorganic particles, polymer residues or fibres, often from production processes or packaging materials.
Yes, for injectable products or liquids in contact with mucous membranes, international pharmaceutical standards (USP, EP) impose precise thresholds for particles per volume.
The results are used to assess the quality of raw materials, validate manufacturing processes and check finished products to ensure they are free from contamination before they are put on the market.
Particle counting is used to detect and eliminate residual particles from the manufacturing processes (machining, cleaning, packaging) of medical devices.
The ISO 19227 standard requires particulate contamination of medical devices to be controlled and limited in order to guarantee their cleanliness and safety. It sets out specific methodologies for measuring, identifying and quantifying residual particles, in particular by particle counting and chemical analysis, in order to comply with defined thresholds for implantable and non-implantable devices.
La norme ISO 19227 impose de contrôler et de limiter la contamination particulaire des dispositifs médicaux afin de garantir leur propreté et leur sécurité. Elle prévoit des méthodologies spécifiques pour la mesure, l’identification et la quantification des particules résiduelles, notamment par le comptage particulaire et l’analyse chimique, afin de respecter des seuils définis pour les dispositifs implantables et non implantables.
