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Medical Device Cleaning

Medical Devices Parts Cleaning

Cleaning Technologies Group (CTG) develops a broad range of precision cleaning solutions, many of which are ideally suited to meet the challenges of medical device cleaning. Our equipment is developed 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.

Aqueous and Ultrasonic Medical Device Cleaning Equipment

Blackstone-NEY Ultrasonics and Ransohoff medical device cleaning solutions include aqueous and ultrasonic cleaning equipment for immersible medical device components that are required to meet rigorous standards for cleanliness. Cleaning, passivation, and decontamination are included as part of our systems. See our recent Medical Device Cleaning blog post.

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.

 

CTG Medical Device Cleaning Equipment Meets Quality Standards

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. 

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 CTG 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.

Download these and other case studies below to learn more about our specific medical device cleaning success stories. Or, feel free to contact us to discuss your specific application.

Medical Device Passivation

The passivation process leads to the formation of a thin layer of oxidation on the surface of a part. This layer serves as a protective coating. While passivation happens naturally in stainless steels and titanium alloys, surface purity can be optimized by treating the materials in a controlled citric or nitric acid process. Approximately 100,000 times thinner than a human hair, this layer is nonetheless extremely durable, and has to be removed through abrasion. The chemical action of passivation is capable of penetrating into the surface of the material 0.00508mm deep.

Blackstone-NEY Ultrasonics ultrasonic cleaning and passivation systems rely on industry compliant materials and fabrication techniques to ensure that they will provide repeatable and reliable results. Advanced designs include redundant control measures, process traceability through data collection/access software, sanitary plumbing and filtration loops, as well as controlled environments.

To help assure process integrity, our systems combine ultrasonic cleaning with pickling, passivation, rinsing, neutralization, and drying and other processing steps in a unitized cleaning console. Labor needed for parts processing can be greatly reduced with the addition of an automated, robotic transfer system. Automation technology can also enhance process consistency. From the removal of gross contaminants to precision cleaning at the sub-micron level, Blackstone-NEY Ultrasonics has extensive experience providing cleaning solutions.

Our team has developed passivation systems for medical applications worldwide using our proprietary Blackstone-NEY Ultrasonic technology as the core component. Through experienced expertise, we assist our customers in the early stages of process evaluation so the correct process and equipment are specified from project beginning to completion.

Applications:

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