Medical Device Cleaning

The broad range of Blackstone-NEY ultrasonic cleaning solutions includes systems that are ideally suited to meet the demands of medical device cleaning. Ultrasonic equipment provides thorough, but gentle cleaning to remove all contaminants from part contours and surfaces for medical device cleaning ensuring satisfaction of the most demanding requirements and standards.

Ultrasonic Medical Device Cleaning Equipment

Blackstone-NEY Ultrasonics’ Aquarius system offers the ideal cleaning system for medical devices with complete ultrasonic cleaning in a single step. We also offer a range of size appropriate options that can reduce cost and improve throughput. Cleaning, passivation, and decontamination are included as part of our systems.

See our recent Medical Device Cleaning blog post.

Medical Passivation

Passivation causes the formation of a thin layer of oxidation on the part surface which acts as a protective coating. This happens naturally in stainless steels and titanium alloys, but the surface purity can be optimized by treating the materials in a controlled citric or nitric acid process. This film is about 100,000 times thinner than a human hair and though the layer can be removed through abrasion, it is extremely durable. The chemical action of passivation will actually penetrate 0.00508mm deep into the surface of the material.

Blackstone-NEY Ultrasonics ultrasonic cleaning and passivation systems use industry compliant materials and fabrication processes to ensure that they are able to provide repeatable and reliable results. Industry-leading design techniques include redundant control measures, process traceability through data collection/access software, sanitary plumbing and filtration loops, and controlled environments.

Ultrasonic cleaning combined with pickling, passivation, rinsing, neutralization, and drying and other processing steps in a unitized cleaning console helps assure process integrity. The addition of an automated, robotic transfer system provides process consistency and significantly reduces the labor required for part processing.

Using our Blackstone-NEY Ultrasonic technology, we have provided passivation systems to the medical markets around the world. Our knowledgeable team supports customers in the early stages of process evaluation to ensure that the correct process and equipment is specified from the start of your project.

Medical Device Cleaning Equipment That Meets Quality Standards

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. All CTG equipment is manufactured according to GMP, which minimizes risks and helps to satisfy applicable end user internal ISO requirements.

Blackstone-NEY Ultrasonics also offers complete documentation according to GAMP 5, allowing for turn-key operation up to product qualification. Guidelines include:

• Design Package
• Equipment Documentation
• IQOQ Procedure Development and Execution

Another quality advantage our team offers is an in-house lab for evaluating material compatibility and cleanliness. This allows us to evaluate an application prior to identifying and developing the most appropriate and effective parts cleaning solution.

Blackstone-NEY Ultrasonics Medical Device Cleaning Proven Successes

Hip and knee implants require an effective cleaning solution that eliminates microbial organism bodies. The Blackstone-NEY Ultrasonics Lean Aquarius ultrasonic tank to tank system has accomplished this, providing filtration, continuous flow cascading rinse tanks, an automated transfer system, data tracking, sanitization, and more, as well as 100 percent dry devices.

The Ransohoff LeanJet RB – Rotary Basket Washer can be a solution for cleaning orthopedic implants. The LeanJet RB-1 handles 4 baskets of parts per hour with no visible debris using a 10x microscope. The system offers the added advantage of efficient operation and a small footprint. Ransohoff can also provide the right chemistry required to clean the medical device parts to meet the clean specifications.