Laboratory analysis of particulate contaminations

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.