Analysis of particulate contamination
What is a particle / contamination ?
Behind the notion of particle or contamination, there is often the notion of size… A particle is a very small part, sometimes residual, of a chemical substance or material.
Often invisible to the naked eye, these particles can be organic or inorganic in origin. They can come from a variety of sources, such as manufacturing residues or chemical impurities.
These particles range in size from a few micrometers to even smaller dimensions, such as nanoparticles, and their presence can have a significant impact on product quality and conformity in all industries.
In short, particles or contamination can be both analysed :
Particle analysis for every industry
In the medical device industry, the presence of foreign particles can jeopardize patient safety. Particle analysis ensures that equipment is free from contamination and meets the stringent quality standards demanded in this sector.
The extreme environments of aerospace require components of exemplary purity. Particle analysis helps prevent defects caused by contamination, guaranteeing the performance and reliability of critical parts in flight or in orbit.
In the cosmetics and pharmaceutical industries, product purity is essential for consumer safety. Particle analysis is used to detect and eliminate contamination, ensuring that products comply with current quality standards and regulations..
The automotive industry relies on precise manufacturing processes where residual particles can affect the performance of mechanical parts. Particle analyse ensures component quality, avoiding the risk of malfunction or premature wear.
In the energy and nuclear sectors, the smallest particle can cause critical malfunctions. Analyse is used to monitor sensitive environments and ensure that materials meet safety and durability requirements.
Luxury brands demand an impeccable finish, free from any visible or microscopic defects. Particle analysis ensures that final products meet the standards of excellence and perfection expected by consumers in this sector.
FILAB has a whole department dedicated to particulate contamination analysis
Our particle and contamination analysis services
Dust particle analysis
Particle counting according to AAMI TIR 42, ISO 19227, PE 2.9.19, USP 788
Analysis of dispersions and micro-dispersions
Our TECHNICAL resources
Particulate contamination in pharmaceuticals and medical devices refers to the presence of extraneous, mobile and undissolved particles that are not intended to be in the product. These particles can cause harm to patients if they are injected or ingested. Therefore, it is important to minimize particulate contamination in medical devices and pharmaceuticals to ensure patient safety. Testing and monitoring methods are used to detect and quantify the level of particulate contamination in these products.
In Europe, medical devices and pharmaceuticals are regulated by the European Union (EU) under the Regulation (EU) 2017/745. This regulation requires manufacturers to demonstrate that their medical devices are safe and effective and meet certain quality standards, including testing for particulate contamination. The regulation sets out specific requirements for the chemical analysis of medical devices and pharmaceuticals, including the need to identify and quantify any particulate contamination. The regulation also requires manufacturers to have a quality management system in place to ensure that medical devices and pharmaceuticals are produced consistently and meet the required standards. Failure to comply with these regulations can result in fines, legal action, and damage to the manufacturer's reputation.
There are several methods used to evaluate particulate contamination in pharmaceuticals and medical devices. Some of these methods include:
- Light obscuration: This method involves passing a liquid sample through a flow-cell and measuring the amount of light that is blocked by particles in the sample.
- Microscopic particle count: This method involves examining a liquid sample under a microscope and manually counting the number of particles present.
- Scanning electron microscopy: This method involves using a high-resolution microscope to examine the surface of a medical device or pharmaceutical product, and identifying and characterizing any particles present.
- Energy-dispersive X-ray spectroscopy: This method involves analyzing individual particles using X-rays and identifying their elemental composition.
- Laser diffraction: This method involves measuring the size distribution of particles in a sample using a laser beam.
- Visible Particle Analysis: This method is used for the detection and identification of visible particles in solution, injection devices, and drug products by trained analysts.
The choice of method depends on the type of product being evaluated, the desired level of sensitivity, and regulatory requirements. FILAB can advise you on which method is best for your needs.
