Why STATIC CONTROL Matters in

Medical Device Manufacturing Environments

Effective contamination control is crucial in medical device manufacturing, particularly due to the impact of electrostatic fields on plastic parts and cleanroom operations. Low static fields, such as 2,000 volts, can attract particulate matter, compromising cleanroom effectiveness. To counter this, the goal is to eliminate static charges.

Simco-Ion, Technology Group’s solutions include Benchtop and Overhead Ionizing Blowers, Ionizing Air Guns, and full-coverage Room Ionization Systems.

Once static is mitigated, addressing existing particles is important. Traditional ionizing air guns can blow off particles but may relocate them within the cleanroom. C.C. Steven’s Particle Capture System (PCS) captures particles at the source, offering various configurations allowing customized solutions to maintain cleanliness and prevent contamination.

Using these tools, static fields can be reduced to below 2,000 volts, eliminating the ability of parts to attract contaminants.

Industry Challenges

Why Static Control Matters in Medical Device Manufacturing

• Particle Contamination – Static charges attract airborne dust and fibers onto sterile device surfaces, increasing contamination risks and cleanroom violations.
• Cleanroom Compliance Issues – Uncontrolled static leads to particle buildup that threatens ISO 14644 standards in aseptic environments.
• Defects During Assembly – Static-induced particle attraction during assembly of small, sensitive components leads to defects and yield loss.
• ESD Damage to Electronics – Devices with embedded circuits (e.g. wearables, diagnostics) are at risk of latent or catastrophic damage from ESD.
• Tool or Process Disruption – Electrostatic buildup near sensitive inspection or robotic systems can cause malfunctions and costly downtime
• Safety Hazards: Uncontrolled static can result in electric shocks, which, while usually minor, could lead to workplace accidents.

Submicron to Visible: Particle Sizes Drawn by ESA