Medical Electronics Symposium Conference Proceedings

Electronic Assemblies & Devices for the Medical Industry: Cleaning & Material Compatibility Challenges

Authors: Jigar Patel, M.S.
Company: ZESTRON Americas
Date Published: 9/16/2015   Conference: Medical Electronics Symposium

Abstract: PowerPoint Presentation Only

Within the medical industry, electronic parts and medical devices must meet the highest quality standards as failure is not an option. Whether one is manufacturing electronic assemblies or devices, precision cleaning of flux and/or metal processing residues is of utmost importance, without adversely affecting material compatibility. For electronic assemblies, residues, either ionic or non-ionic, must be fully removed. Partially removed or untouched residues can lead to component and product failure resulting from electrochemical migration, dendritic growth and electrical leakage currents. Regarding medical devices, contamination from the manufacturing processes such as electro-polish solution, coolants, paraffin lubricants, and soda blast residues must be completely removed in order to meet the required cleanliness standards.

Within this presentation, two case studies are presented detailing the challenges presented and solutions offered to two manufacturers, one producing Class 3 electronic assemblies and another medical devices.

Case Study 1: A global electronics contract manufacturer had a requirement to identify and qualify a cleaning process capable of removing combinations of No-Clean, lead-free, leaded paste, and liquid flux residues utilizing industry approved test coupons. Using IPC-B-24 and IPC-B-25 test coupons, the test protocol included identifying an aqueous cleaning agent, confirming compatibility with existing equipment and components, establishing cleaning process parameters, and verifying cleanliness results using IPC standards. Wave systems and reflow ovens were used to solder the coupons with multiple types of solder pastes and wave fluxes. The coupons were cleaned using an aqueous cleaning agent and spray-in-air cleaning equipment.

Case study 2: A global medical products manufacturer sought an environmentally friendly alternative to their current acidic cleaning process. In addition to meeting the cleaning requirements, the alternative cleaning process required a greater level of process control as well as be compatibility with the materials currently used.

In the case of the electronics manufacturer, the authors were able to identify and quantify the critical parameters impacting cleanliness for Class 3 assemblies components utilizing numerous IPC assessment standards. For the medical device manufacturer, a cleaning process was identified meeting their cleanliness process control and compatibility requirements.

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