ANALYTICAL & LAB EQUIPMENT
Fighting ESD in cleanroom
Cleanrooms present unique challenges for ESD control
environments
Elizabeth Norwood, a senior chemist from MicroCare, explores how to protect sensitive cleanroom devices while ensuring they maintain quality and functionality
E
lectronic medical device manufacturers face the ongoing challenge of maintaining product reliability
and performance. Electrostatic discharge (ESD) poses a serious threat across all production settings, particularly in cleanrooms. Sensitive devices like pacemakers, insulin pumps, imaging systems, and patient monitors are especially at risk owing to their intricate electronics. As these technologies become more compact and sophisticated, the potential for ESD-related damage increases. To address this, manufacturers must implement robust protection measures while adhering to strict regulatory requirements to ensure product quality and functionality.
WHAT IS ESD? Electrostatic discharge occurs when two objects with diff ering electrostatic potentials come into proximity or contact, resulting in a rapid transfer of electrons. Even minor ESD events can have severe consequences in manufacturing, particularly for sensitive electronic components such
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as Printed Circuit Board Assemblies (PCBAs), which are integral to many modern medical devices. ESD-related failures in medical
devices typically take two forms: catastrophic failure and latent damage. Catastrophic failure results in immediate and detectable malfunction, often found during manufacturing or initial quality control procedures. Latent damage, however, poses a more complex challenge. Devices aff ected by latent ESD damage may pass initial tests but experience premature failure in the fi eld, potentially compromising patient safety and the manufacturer’s reputation. While essential for keeping sterility
and precision in medical device production, cleanrooms present unique challenges for ESD control. Low humidity levels, necessary to inhibit microbial growth, can increase the risk of static build-up. Even though cleanroom garments are designed to prevent contamination, friction from personnel movement can still generate static charges. Routine activities like walking across the cleanroom fl oor can create static potentials,
sometimes reaching thousands of volts if ESD control measures are not eff ectively managed. Furthermore, many cleanroom
surfaces and equipment are constructed from insulating materials that can accumulate static charges.
ADDRESSING THE RISK OF ESD To address these challenges, medical device manufacturers should implement a comprehensive, multi- faceted approach to ESD control. This strategy begins with personnel management. All staff working in the cleanroom should use anti-static wrist straps or heel grounders connected to verifi ed ground points. These devices continuously dissipate static charges that accumulate on the human body. ESD-safe footwear and clothing, including cleanroom-compatible garments manufactured from static- dissipative materials, further mitigate the risk of charge generation and accumulation. Environmental modifi cations play
a crucial role in ESD mitigation. Conductive fl ooring or fl oor mats
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