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Ultrasonics Provide Ideal Solution for Medical Devices

Medical device cleaning presents a unique set of challenges. Extremely rigorous cleaning standards are maintained for instruments used in surgery, medical and dental procedures, as well as devices used as medical implants. While these devices often have difficult to clean features like blind-holes and designed-in porosity, they also have the most stringent requirements for disinfection and sterilization.

The conventional approach to sterilization of medical devices has been the use of high-pressure steam or vaporized hydrogen peroxide (VHP). When medical devices are inadequately cleaned however, residual soil can effectively seal in contamination, actually preventing proper disinfection and sterilization. Thus, a capable and robust precision cleaning process is the pre-requisite for sterile device manufacturing.

The unique characteristics of ultrasonic cleaning make this automated cleaning method ideal for medical device cleaning. The ultrasonic cleaning process has been demonstrated to be more effective than other types of cleaning, and is also safer, more repeatable, and more efficient than manual cleaning. Ultrasonic cleaning systems easily and thoroughly remove a wide range of debris from medical devices without damaging the part substrate.

Ultrasonic cleaning uses cavitation, an effect created when ultrasonic waves pass through a liquid medium, creating unstable voids in the cleaning bath. The collapse of these millions of tiny voids (or cavities) results in the release of tremendous energy to disrupt the boundary layer and flush contamination from the part surfaces. This energy effectively dislodges soil and contaminants on all surfaces, including intricate crevices and blind holes.

Cleaning Technologies Group (CTG) offers a broad range of precision cleaning solutions, including Blackstone-NEY ultrasonic systems, which are ideally suited to meet the challenges of medical device cleaning and surface treatments such as passivation or etching. All of our cleaning equipment is designed to provide thorough, but gentle cleaning to remove all contaminants from part contours and surfaces for medical device cleaning that meets the most demanding standards.

Blackstone-NEY Ultrasonics’ Aquarius platform offers the ideal cleaning system for medical devices with complete ultrasonic cleaning and surface treatment options in a single automated system. We also offer a range of size appropriate options that can reduce cost and improve throughput. Combining ultrasonic cleaning with rinsing, drying and other processing steps in a unitized cleaning console helps assure process integrity. The addition of an automated, robotic transfer, environmental enclosure and de-ionized water systems increases cleanliness levels and provides process consistency and significantly reduces the labor required for parts cleaning. The control systems on the Aquarius platform can also support medical industry compliance with 21 CFR Part 11 including electronic records and audit trail functionality. Systems are offered with GAMP5 compliant control of the automated cleaning and surface treatment processes as well as the supporting qualification documentation.

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