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Laboratory analysis of particulate contaminations
What is particulate contaminations ?
Behind the idea of particulates or contaminants there is often the concept of size… A particle is only a tiny, sometimes residual, portion of a chemical substance or of a material.
Usually fine and minute, small particles cannot be seen by the naked eye.
Particulates or contaminants can often be analyzed :
- As part of a set of conformity analysis : verification of the size of particles or microparticles or even nanoparticles.
- As part of a more complex study, in the context of a contamination during the production process for example : particulates embedded in the surface of a metal part, dust contamination, cross contamination…
FILAB has a whole department dedicated to particulate contamination analysis
FILAB laboratory can offer particulate analysis services tailored to your needs :
- Chemical analysis of particles and particulate contaminations identification
- Dispersion and micro-dispersion analysis
- Nanomaterial characterization
- Dust analysis
- OM and SEM-FEG-EDX microscopy analysis
- FTIR particulate analysis and spectral interpretation
- Particulate analysis of pharmaceutical products
- Granulometric analysis : laser granulometry, sieving…
FILAB also offers analytical services complementary to particulate contamination analysis, all with high added value :
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²
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.
Around this topic
- Laboratory for particle size distribution analysis according to ISO 17025
- Particle counting laboratory according to USP 788
- Laboratory for particle counting in pharmaceutical solutions
- Particle Counting Laboratory for Medical Devices
- PHARMACEUTICAL INDUSTRY: identification of particles in a solution