Better Engineering ultrasonic cleaning and passivation systems use industry-approved materials and fabrication processes to ensure repeatable and dependable results.
In the medical device industry, parts cleaners are often used to passivate parts as part of the manufacturing and finishing processes. Passivation is a critical step that enhances the corrosion resistance of metal surfaces, ensuring that medical devices remain safe and reliable during their intended use. Let’s delve into how Better Engineering ultrasonic parts cleaners and passivation systems facilitate the passivation of parts in the medical device industry.
Passivation is a chemical process that removes surface contaminants and promotes the formation of a protective oxide layer on the surface of metal parts. This oxide layer acts as a barrier, preventing further corrosion and improving the longevity of the metal. Passivation is particularly important for medical devices that come into contact with bodily fluids, as it helps maintain the integrity and biocompatibility of the devices.
Before passivation, parts must thoroughly clean to remove contaminants, oils, or residues that may interfere with the passivation process. BE’s ultrasonic parts cleaners play a vital role in this initial cleaning stage by utilizing various cleaning agents, detergents, and temperature-controlled systems to remove surface impurities effectively. The subsequent passivation process can be more effective by achieving a clean, debris-free surface.
Cleaning systems are typically equipped with specific passivation chemistry or passivating agents suitable for medical device materials. The passivating agents commonly used in the medical device industry are typically based on nitric acid formulations, often with a combination of other chemicals such as citric acid or sodium dichromate. These agents help remove any remaining iron or iron oxide particles, activate the metal surface, and facilitate the formation of a passive oxide layer.
Temperature and Time Control:
Passivation processes may require specific temperature ranges and dwell times to achieve optimal results. Precision cleaning systems with temperature control capabilities ensure the passivation process occurs within the recommended temperature range for the specific passivating agent. Similarly, precise dwell time control allows the passivating agents to work effectively, promoting the formation of the desired oxide layer.
Rinse and Neutralization:
After the passivation process, parts must be thoroughly rinsed to remove any residual passivating agents. Parts Cleaners provide the necessary rinsing capabilities, including multiple rinsing stages, to ensure the complete removal of the passivating agents. Some parts washers may also incorporate neutralization steps to neutralize any remaining traces of acidic solutions, ensuring the parts are safe and ready for subsequent manufacturing or assembly processes.
Quality Control and Validation:
Passivation is a critical step in ensuring the corrosion resistance of medical device components. Parts washers aid in quality control and validation by providing consistent and repeatable passivation processes. Manufacturers can validate the passivation process by monitoring critical parameters such as temperature, chemical concentration, dwell time, and rinse cycles to ensure compliance with industry standards and regulatory requirements.
By utilizing cleaning systems for passivation, the medical device industry can enhance the corrosion resistance of metal parts, reduce the risk of contamination or device failure, and extend the lifespan of the devices. Passivation plays a crucial role in maintaining medical device safety, reliability, and performance, and parts washers contribute significantly to achieving these objectives.
Ultrasonic cleaning is combined with passivation, rinsing, drying, and other processing steps to ensure integrity. To further improve processes and reduce contamination, robotic transfer systems are available to help process consistency and significantly reduce part processing labor.