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Medical Device Manufacturing Static Control Solutions

Critical Protection from Particle Contamination

Adhering to FDA regulations is paramount in medical device manufacturing to ensure product safety and efficacy. One critical aspect of this compliance is understanding and implementing the FDA 21 CFR 820.30 design controls. These controls are essential for manufacturers of Class II and III devices and specific Class I devices to establish and maintain procedures that govern the design process. It ensures the design meets all specified requirements, protecting patient safety and device performance. Static control methods play a significant role in maintaining compliance with these design controls. 

By integrating static control measures with ionizers, manufacturers can prevent static discharge, which could otherwise compromise the integrity of sensitive electronic components within medical devices. This proactive approach aligns with FDA 21 CFR 820.30 design controls and enhances the manufacturing process’s overall quality and reliability, ensuring that devices meet stringent regulatory standards. Furthermore, the implementation of static control measures supports the broader objectives of the FDA’s Quality System Regulation (QSR), which encompasses design controls as a fundamental component. By mitigating risks associated with static electricity, manufacturers can focus on delivering safe and effective medical devices, fulfilling regulatory requirements, and meeting market expectations. This alignment with FDA guidelines underscores the importance of comprehensive static control strategies in achieving compliance and maintaining high-quality production standards.

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Industry Challenges

Why Static Control Matters in Medical Device Manufacturing Environments
 
         
                     
PARTICLE
CONTAMINATION
Static charges pull particles onto sterile surfaces, risking contamination
 
COMPLIANCE
ISSUES
Uncontrolled static causes particle buildup that risks ISO 14644 compliance
 
ASSEMBLY
DEFECTS
Static attracts particles during assembly, causing defects and yield loss
 
ELECTRONIC
ESD DAMAGE
ESD can cause latent or catastrophic damage to embedded electronics
 
TOOL OR PROCESS DISRUPTION
Static near inspection tools can trigger malfunctions and downtime
 
SAFETY
HAZARDS
Uncontrolled static can cause shocks and
workplace accidents

Industry Regulation

What Regulations Address Static Control in the Industry?

Several regulations and standards address static control in medical device manufacturing to ensure product safety and reliability.

  • FDA Regulations — The U.S. Food and Drug Administration (FDA) enforces quality management system regulations, including the Quality System (QS) regulation (21 CFR Part 820), which incorporates ISO 13485:2016 for medical device quality management.
  • ISO 13485 — This international standard outlines requirements for quality management systems in medical device manufacturing, ensuring compliance with regulatory standards.
  • CE Marking (Europe) —  Medical devices in Europe must comply with the Medical Device Regulation (MDR) and bear the CE mark, indicating conformity with health, safety, and environmental protection standards.
  • Electrostatic Discharge (ESD) Guidelines —  Specific guidelines exist for controlling electrostatic discharge in cleanrooms, as ESD can damage sensitive medical devices during production.

Key Application Areas

Medical Device Manufacturing Applications We Support
  • Cleanroom – Gowning Room and Production Area
  • Injection Molding — Prevent static buildup on plastics
  • Assembly — Protect sterile fields from particulate
  • Packaging & Sealing — Prevent misalignment or film cling
  • Optical Testing — Eliminate dust interference on lenses/displays
  • ...and more!

For additional information on medical device manufacturing solutions for static control and particle contamination control, contact Sales Services.

Benefits of Static Control

  • Enhanced Product Quality — Prevents ESD damage and ESA-caused-contamination during the assembly of sensitive components, reducing defects and rework.

  • Sterility Protection — Minimizes ESA-caused-contamination on sterile surfaces, supporting ISO and GMP cleanroom standards.

  • Regulatory Compliance — Supports adherence to FDA 21 CFR 820 and ISO 13485 by reducing contamination risk in validated environments.

  • Process Stability — Reduces unplanned downtime caused by ESD induced EMI-related tool disruptions or inconsistent assembly performance.

  • Higher Yields — Protects devices with embedded electronics (e.g., diagnostics, implantables) from latent failure due to ESD.

  • Inspection Readiness — Helps ensure audit-ready cleanrooms and traceable static control across critical operations.

Our Solutions

Targeted Solutions for Critical Environments

Product Groups

Models

Room Ionization System

Model 5515 Room System

Ionizing Blowers

minION, 6832, PC2, XC2, Aerostat FPD, Aerostat Guardian, CR2000

Ionizing Bars

Aerobar 5225

Special Application Fusion, IonONE Micro S & SA

Ionizing Air Guns & Nozzles

AirForce 6115, TopGun, Orion

Static Control Monitoring Systems

Novx 3352, Novx 3362, Novx 7000Minipulse

Instrumentation Fieldmeter 775 or Fieldmeter FMX-004, 775PVS, CPM280A