Methods for critical cleaning
Vapor degreasing is a closed-loop system that uses highly-advanced, low-boiling and non-flammable cleaning fluid to remove contamination.
MicroCare Medical

Methods for critical cleaning

Features - Cleaning

Reliable electronic medical devices demand manufacturers have their fingers on the pulse of cleaning.

April 23, 2021

Vapor degreasing is a closed-loop system that uses highly-advanced, low-boiling and non-flammable cleaning fluid to remove contamination.

The medical electronics market is increasing every year because of an aging population, growth in developing countries, and an awareness in improving health.

Patient monitoring and wearables demand smaller, highly complex electronics, but this brings reliability concerns. Medical devices must have long-term functionality and withstand rigorous regulations. It’s important that procedures are put in place during design and manufacturing to guarantee electronic components’ consistency. An important step in the assurance of an electronic device’s functionality is quality cleaning.

Growth in medical electronics

Technology is driving improvements and enhancing healthcare, with advanced circuitry as the backbone to today’s medical developments.

The medical electronics market was estimated to be worth $5.1 billion in 2019 and is projected to reach $6.6 billion by 2025, at a compound annual growth rate (CAGR) of 4.6% from 2019 to 2025. Expanding rates of chronic diseases; increasing adoption of medical imaging, monitoring, and implantable devices; rising expenditure on healthcare across the world; and a growing elderly population are all factors for growth.

One area hugely impacting this growth is remote patient monitoring (RPM) that allows patients’ mobile electronic medical devices to gather and record health data for healthcare professionals. Data can include glucose level, weight, blood pressure, and heart rate. By implementing RPM devices, healthcare can be less invasive and more private for patients. Medical management can move outside the hospital setting, reducing the burden on healthcare facilities. It also reduces contamination risk, an area of particular importance during the coronavirus pandemic.

Medical electronic devices such as RPM must be reliable to advance. Procedures put in place when manufacturing medical electronic devices have a huge impact on reliability. One method helping to maintain consistency is quality circuitry cleaning, which directly translates to more effective printed circuit boards (PCBs) and better medical electronics.

Miniaturization makes PCBA cleaning more difficult

Contaminants make a difference

Medical electronics are getting smaller and more complex as demands from healthcare providers, practitioners, and patients call for more functions and increased portability. This can create a reliability challenge as smaller, more densely populated printed circuit boards make managing faults, quality, and product longevity challenging.

The smallest contaminant, whether it’s flux residue, oils, or inorganic contamination resulting from the manufacturing process can form a barrier between electrical contacts on the circuit boards. Contaminated printed circuit board assemblies (PCBs) are susceptible to numerous problems that increase as part sizes shrink.

Miniaturization makes cleaning more difficult, leaving dirty circuit boards vulnerable to performance problems, including electrochemical migration and delamination, parasitic leakage, dendrite growth, and shorting – all of which can result in malfunction.

Cleaning is an essential step for electronic medical devices to function consistently.

Proper cleaning is essential to implantable electronics reliability and performance.

Cleaning for reliability

Improved cleaning directly translates to more effective PCBs and more reliable medical electronics. Medical device manufacturing processes must be validated as precise and repeatable. Devices must pass extremely stringent tests and regulatory requirements, be free from contaminants to function consistently, and meet high standards. For example, implantable electronic devices must function as designed and remain bioburden-free while in service. Cleaning is essential to implantable electronics and other monitoring and therapeutic applications where accuracy is crucial to diagnosis.

The answer to reliable and consistent cleaning lies within vapor degreasing. Vapor degreasing, a closed-loop system, uses advanced, low-boiling and non-flammable cleaning fluid to remove contamination. The method is effective, fast, economical, flexible, and compliant with most environmental regulations. It ensures that electronic parts, no matter how dense the circuitry or how complex, are precision cleaned.

Vapor degreasers have a relatively small footprint, so they don’t require much cleanroom space. The solvents are hostile to bacteria and mold growth, making cleanroom bioburden validations much less complicated than most water-based cleaning systems.

Other benefits

Low-boiling cleaning fluids have many properties that benefit medical PCB cleaning. They typically have a low surface tension, very low viscosity, minimize the potential for electrostatic damage, and dry quickly without residue. Fluid can penetrate and clean compact spaces and under the small parts now common in medical electronics. Most vapor degreasing fluids are also heavy and dense, which further aids in dislodging flux and solder paste particulate from around and under components.

Fluid properties support cleaning electronics of virtually any geometry or size, even delicate parts, and drying them without damage. Drying is important within medical electronics because even a tiny amount of moisture remaining in hard-to-reach areas can encourage bacterial growth. If the bioburden risk is not properly addressed, it can increase complications during product validation, impact outcomes of required ISO 10093 tests, and even affect the finished device’s long-term reliability.

Importantly, modern cleaning fluid is sustainable and safer than legacy solvents, meeting strict environmental laws regulating cleaning fluid use and disposal.

Modern sustainable cleaning fluids don’t require stabilizers, scavengers, or weekly acid acceptance testing often required for chlorinated or brominated cleaning solvents. New cleaning fluids are easily recycled by distillation in the vapor degreaser, increasing their service life and reducing overall maintenance costs.

Cleaning is one of the most important measures in the manufacture of delicate electronic medical devices, and one that can be achieved consistently with a modern vapor degreaser.

Don’t risk reliability

With the medical electronics market set to increase, it’s important to integrate precise cleaning procedures that are easy to validate with long-term cleaning performance that’s consistently reliable. As the number of electronic devices being manufactured grows, the risk of failure does as well. Insufficient cleaning can result in malfunction, with disastrous consequences to those using the device and to the company supplying it.

For companies seeking to implement sustainable vapor degreasing cleaning fluids, it’s essential to work with a partner with expertise in this area. Based on detailed parts make-up and the contamination encountered, they can recommend the sustainable fluids and cleaning methods that will work best for medical electronic devices.

MicroCare Medical

About the author: Jay Tourigny is senior vice president at MicroCare Medical. He has been in the industry more than 30 years and holds numerous U.S. patents for cleaning-related products used daily in medical and precision cleaning applications.