Feature: Medical


Vapour Degreasing: High performance cleaning for consistency and scalability Vapour degreasing is a closed-loop cleaning process that uses heated cleaning fluid to produce vapour. Components are first immersed in the heated fluid for cleaning, then exposed to the vapour, which condenses and liſts away contaminants. A final rinse in clean fluid or vapour ensures thorough, residue-free cleaning while reducing waste, operator intervention, and process variability.


Advantages of vapour degreasing in process validation Vapour degreasing offers several


advantages that make it an ideal choice for cleaning electronic medical devices. Key Benefits of vapour degreasing include: • Superior penetration – Vapour-phase cleaning fluids reach into micro-gaps and under-component spaces, ensuring complete residue removal.


• Non-Damaging process – Te low surface tension and viscosity of cleaning fluids prevent thermal and mechanical stress on delicate components.


• Consistent, repeatable cleaning – Provides stable, validated cleaning outcomes across production batches that are easy to document.


• Efficient and cost-effective – Te closed- loop system minimises waste, cleaning fluid usage and operational costs.


• Scalability: Accommodate various batch sizes, part sizes and geometries.


• Cleanroom compatibility – Does not introduce moisture, dust, or particulates, making it ideal for cleanroom environments. By integrating vapour degreasing into


their cleaning processes, manufacturers can streamline validation procedures while enhancing product reliability and regulatory compliance.


Meeting regulatory validation protocols For a cleaning process to be considered validated, manufacturers must set up detailed Standard Operating Procedures (SOPs) and follow industry regulations, including: • (MDR) (EU) 2017/745 • US FDA Quality System Regulation (21


CFR Part 820)


• ISO 13485 – Medical Device Quality Management Systems


• ISO 14644 – Cleanroom Standards • IPC-A-610 & IPC-CH-65B – PCB Cleaning Guidelines Medical Device Regulation (MDR) (EU) 2017/745 requires manufacturers to set up and keep Quality Management Systems (QMS) with well-documented SOPs for all aspects of device production. Both benchtop and vapour degreasing methods align with this requirement, offering precisely controlled and documented cleaning parameters that support compliance and long-term reliability.


Ensuring quality and safety in cleaning validation A validated cleaning process is more than


just residue removal. It plays a crucial role in quality assurance, regulatory compliance and operational efficiency. Process validation ensures that cleaning methods consistently achieve the required cleanliness levels while optimising performance. Key benefits of effective cleaning validation include: • Regulatory Compliance – Meeting MDR, FDA, ISO and IPC standards


• Consistent and Reliable Cleaning Results – Ensuring repeatability across production batches


• Enhanced product longevity and performance – Preventing contamination- related failures


Environmental and operational benefits Modern cleaning techniques like


benchtop and vapour degreaser cleaning, when used with environmentally responsible cleaning fluids that follow air quality and operator safety regulations have several environmental and operational benefits. Tey include:


• Energy efficiency: Vapour degreasers and benchtop cleaning systems require minimal energy and have a compact footprint suitable for cleanroom environments.


• Operational cost reduction: Te closed- loop system in vapour degreasing minimises waste and maintenance needs,


while benchtop cleaning, when used in combination with a cleaning fluid delivery system, allows targeted use of cleaning fluids.


• Cleanroom compatibility: Both methods do not introduce dust, fumes, or moisture, reducing bioburden risk and supporting cleanroom conditions.


Developing standard operating procedures for PCBA cleaning Te first step toward successful process validation is defining cleaning protocols. Manufacturers must set up detailed standard operating procedures (SOPs) that outline: • Cleaning fluid choice • Cleaning equipment choice • Process parameters and controls • Validation criteria and documentation By integrating both benchtop and vapour


degreasing into their cleaning and validation protocols, medical device manufacturers can confidently meet stringent regulatory cleanliness requirements while enhancing operational efficiency and product reliability. In electronic medical device manufacturing,


cleaning is not an aſterthought, it is a critical part of process validation. Implementing benchtop cleaning and vapour degreasing ensures that manufacturers meet stringent cleanliness standards while supporting product reliability and compliance. By validating their cleaning processes,


manufacturers can confidently deliver high- quality, high-performance medical devices that support patient safety and regulatory excellence.


www.electronicsworld.co.uk March 2025 29


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