Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • Human factors and operational controls in a medical device cleanroom

    With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.

  • Two laboratory professionals in cleanroom attire, including hair covers, masks, and gloves, working in a high-tech lab. One person is using a microscope at a workstation, while the other operates a machine in the background. The environment is clean and well-organized, featuring advanced scientific equipment and tools.

    Cleanroom best practices are crucial to maintain a contamination-free environment, especially in industries like pharmaceuticals, semiconductors, biotechnology, healthcare, and medical devices. Here are some essential guidelines for ensuring your cleanroom is indeed clean.