ESD Cleanrooms – Static Control for Medical Devices & Life Sciences PDF from Simco-Ion

Preventing Electrostatic Discharge (ESD) in Medical Device & Life Science Manufacturing

Static charge has many adverse effects on manufacturing processes, particularly in cleanrooms for sensitive medical devices, electronics, and panel displays. Devices with critical dimensions such as catheters, syringes, web films, tubing, tool covers are very sensitive to electrostatic discharge (ESD). Here we’ll focus on how ESD impacts medical devices in ways that are often not visible until the device is examined under an electron microscope. When a device fails in the field, the cost of repairing and replacing the unit may exceed 100X the cost of having realized the defect during the manufacturing process.

Simco-Ion Guide to Cleanroom Air Ionization & Contamination Control

Our friends at Simco-Ion sent us this brilliant guide to cleanroom ionization principles that prevent static prevention. Below we’ve provided a short preview. To access the full digital PDF version or print booklet, tell us where to deliver it below. 


Ionizing Guns

Controllers & Power

Overhead Ionizers

It is well known that ESD causes electronic device failure during the production, packaging and testing processes. For medical device products with critical electronic components, damage during manufacturing from electrostatic forces can introduce metrology errors and latent errors where devices fail with customers once the product is in use. 

Since many new products use very sensitive electronic assemblies with active sensors, the possibility of latent failures is growing. As the critical dimensions and tolerances of components and circuits become progressively smaller, they become less tolerant to ESD. In circuits designed to operate at lower and lower voltages, minute levels of charge can result in damage or destroy a device. 

ESD Packaging and Material Handling for Medical Devices

Static charge causes difficulty in many materials and can create problems in feeder tools for product assembly and web tools producing medical sheet products. Electrostatically charged components in feeder bowls can lead to stiction (static friction) problems as parts are moved to assembly points in tools. Medical product assembly tools which have feeder bowls are also susceptible to jamming from the buildup of electrostatic charges. 

Is Electrostatic Attraction (ESA) Hindering Decontamination in Your Cleanroom Facility?

If a critical product surface becomes charged, the surface attracts airborne particulates in the cleanroom. Regardless of the filtration system, personnel, machinery, and processes can introduce particulates into the air. The ESA affecting these particles is surprisingly strong. Once bonded to a charged surface, it is very difficult to remove the contamination. Cleanroom airflow will not have enough force to remove it. Contamination of this nature is the major contributor to product degradation and rejection in Life Sciences product manufacturing. 

What Are the Best Methods of Eliminating ESD and Static-Driven Device Failures in Medical Device Cleanrooms?

It is usually impossible to completely eliminate static electricity from production environments, but with proper use of equipment and remedial procedures, most static problems can be controlled. Many approaches to controlling static charge have been tried over the years. It is clear that no single method exists for controlling all static problems. An important consideration in selecting the proper method is whether the charged material is a conductor or an insulator. Static on a conductor can be easily controlled if the object can be grounded.

What Are the Most Important Considerations for ESD Workstations during Medical Device Packaging and Cleanroom Production?

ESD workstations provide protection with static-dissipative table tops and mats and conductive floors. Materials and devices can be transported in protective bags, bins, and boxes made of conductive or static-dissipative materials. These “passive” procedures cannot always be employed and are subject to human error. Download the PDF to learn about which types of materials are most problematic for static control and explore how ionizers can improve throughput. 

The Advantage of Grounded Cleanroom Workstations and ESD Garments

Grounding simply provides a path so that charge can migrate to or from the ground. When a conductor is grounded, all of its charge is neutralized and remains at ground potential. But because the charge does not migrate on insulators, grounding does not work. Grounding an insulator neither removes the charge nor affects the ability of the insulator to become charged. Providing they follow a strict routine, personnel can be grounded through the use of static-dissipative suits, smocks, gloves, and wrist/heel straps.

ESD Workbenches establish a zero-potential ground between the floor/earth, a worksurface, and a user. Conductive ESD-safe surfaces channel, slow down, and shield electrically sensitive devices from defects and device failure. For electronics manufacturing, a work surface resistance point to point is ideal above 1.0 x 106 but below 1.0 x 109.

What Type of Air Ionization Equipment Is Best for Medical Devices and Life Sciences Manufacturing?

All air ionization systems work by flooding the atmosphere with positive and negative ions. When ionized air comes in contact with a charged surface, the charged surface attracts ions of the opposite polarity. As a result, the static electricity that has built up on products, equipment, and surfaces are neutralized. Simco-Ion provides an in-depth explanation of each type of ionization method here.

Learn Which Type of Ionization Method is Ideal for Your Facility

  • Alternating Current (AC)
  • Steady-state DC
  • Pulsed DC
  • Nuclear
  • X-ray

Guardian Cleanroom-Rated Low Balance 2-Fan Overhead Ionizing Blower, 120V

Simco-Ion’s Guardian CR2000 Cleanroom-rated Overhead Ionizing Blower is designed specifically for use in cleanroom applications. The Guardian CR2000 features a patented circuit that results in balanced delivery of positive and negative ions, which ensures that the unit will maintain an ion balance of 0 ±5V. Balance stability is further enhanced by use of Simco-Ion’s unique “ion shields” at the fan outputs to reduce parasitic ion loss.

Ionization Within Cleanroom Gowning Rooms

Gowning rooms are the main entry point for contamination entering cleanrooms. Personnel bring contamination from outside the clean room which is then distributed throughout the production facility and onto the exposed product. The transfer will occur between street clothes and smocks or bunny suits when the contamination-laden clothing is in the vicinity of the gowns through the static attraction. An appropriate ionization system in the gowning area can remove upwards of 1 million particles 0.5 um and greater which is then prevented from entering the manufacturing environment.

Air Ionization for Particulate & Contamination Control by Simco-Ion
Theory & Practice for Life Science Manufacturing

Within the PDF you’ll find examples and descriptions of each type of ionization technology and how it applies to different industries. Explore case studies, technical information, and static control methods to reduce particle retention and curb ESD events that cause late developing product defects and failures. 


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Mitch Walleser

Mitch Walleser

Mitch works with manufacturing engineers and product specialists to examine new technology and products. His background includes 3D printing, electronics and cleanroom manufacturing. Stay up to date with new insights on automated production solutions by following on Twitter. @Go_to_PAC

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