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The 5 Primary Sources of Particle Generation in Medical Device Manufacturing

by | Mar 1, 2023

Combination medical devices are used extensively in the healthcare industry for various purposes, including drug delivery, wound healing, and tissue regeneration. These devices are typically made up of a combination of materials, such as plastics, metals, and biological components, and are designed to deliver multiple therapies or perform various functions. However, during the manufacturing process, particles can be introduced into the devices, posing a risk to patient safety. This blog post will explore the primary sources of particle contamination in manufacturing combination medical devices.

  1. Raw Materials: One of the primary sources of particle contamination in manufacturing combination medical devices is the raw materials used in their production. The particles may be introduced into the materials during harvesting, processing, or transportation. For example, if the raw materials are not properly stored or handled, they may become contaminated with dust, dirt, or other particulate matter. Similarly, if the raw materials are not adequately cleaned before use, they may introduce particles into the final product.
  2. Manufacturing Equipment: The equipment is another source of particle contamination in manufacturing combination medical devices. The equipment may generate particles due to wear and tear, corrosion, or other factors. Additionally, the equipment may need to be adequately cleaned or maintained, which can lead to the accumulation of particles on its surfaces. These particles can then be transferred to the product during the manufacturing process.
  3. Manufacturing Environment: The manufacturing environment can also be a source of particle contamination. Airborne particles can enter the manufacturing area through HVAC systems, open doors and windows, and personnel movement. Similarly, particles can be introduced into the environment through cleaning, maintenance, and product handling. If the manufacturing environment is not controlled correctly, the particles can settle on surfaces and become part of the manufacturing process.
  4. Personnel: Personnel working in the manufacturing environment can also introduce particles. Particles can be shed from clothing, hair, and skin and introduced into the product during handling or assembly. In addition, personnel may bring particles into the manufacturing area on tools, equipment, or personal belongings.
  5. Packaging and Shipping: Finally, the packaging and shipping of combination medical devices can also introduce particles into the product. Particles can be present during the packaging process, as well as during transportation and storage. If the packaging is not sealed correctly or stored, particles can enter the product and become a source of contamination.

In conclusion, manufacturing combination medical devices involve various materials, equipment, environments, and personnel, all of which can contribute to particle contamination. Manufacturers must proactively identify and mitigate these contamination sources to ensure their products’ safety and efficacy. Foamtec’s PolyCHECK particle identification service is designed to allow device manufacturers to identify sources of particle contamination quickly and efficiently. By identifying sources of contamination manufacturers can close CAPAs and take proactive measures to improve device quality.

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