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.
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.
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. 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 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.
Introducing the NEW Torrent M Series
Torrent M Series automated ultrasonic aqueous cleaning systems for high precision Medical and Pharmaceutical cleaning applications. The Torrent is a single chamber, front loading rotary basket style machine that features 640 watts of Blackstone-NEY single or multi-frequency Ultrasonics for vacuum and non-vacuum immersion wash or rinse, basket rotation with user selected speed, direction and short cyclic modes, compressed air blow-off, spray rinsing and hot air dry or vacuum dry with hot air assist.
- Knee Implants () Download Case Study
- Hip Implants () Download Case Study
- Trauma Implants ()( Download Case StudyWatch Video)
- Bone Screws
- X-Ray Targets & Tubes
- Surgical Blades & Needles
- Spine Implants () Download Case Study
- Spinal Implants - Tulips, Rings, Shanks and Set Screws () Download Case Study
- Blood Transfusion Bellows () Download Case Study
- Cutting Dies () Download Case Study
Blackstone-NEY Ultrasonics is designed for easy setup that will help you improve your cleaning process specifications very quickly.