FDA Registration and new developments in raw materials by Tsubaki Nakashima to support the Medical Industry.

Tsubaki Nakashima’s Michigan production factory has recently received FDA Registration number 3014717638 for our Class 8 compliant cleanroom. “We are very excited for this achievement and the new opportunities it will mean for us and our customers” said Nancy Whitworth, Sales Manager. Achieving this result during a global pandemic has been especially challenging. Through it all the experienced staff at TN Michigan has stepped up and pressed on working as essential employees to support our customers’ needs. We remain optimistic that all our precautions to protect our employees will continue to enable us to meet the increased production demand to support our front-line medical workers against the pandemic fight.

Anyone who is working in a production environment is aware of the increased need for personal safety precautions ranging from increased use of PPE to extraordinary cleaning requirements on a factory-wide scale. Keeping our employees safe and production ready is an absolute necessity to help respond to the increased need for medical equipment and diagnostic devices.

At Tsubaki Nakashima our products are used by our customers to produce critical medical equipment components such as CT Scanners, MRI machines, and diagnostic test products for COVID-19 and other conditions. This year has seen a marked increase in the demand for rolling elements produced from ceramics, plastics, and stainless steels not only due to the pandemic, but to the overall advancement in medical procedures.

Computer tomography (CT) scanners would not function properly without high precision bearings and linear systems to ensure the most precise images are captured. Any vibrations or noise will reduce the quality of the CT scanner and could affect proper diagnosis. To minimize these detrimental conditions, high precision bearing balls and guides are used to guarantee quiet and smooth operation at all operational speeds. Tsubaki Nakashima FB ball screw linear system is ideally suited for this application with customized diameters and lengths. Magnetic resonance imaging (MRI) machines, like CT scanners, capture images thru rotation of the scanner body. Specifically, for MRI equipment, metal and magnetic content in the components must be minimized or eliminated to avoid image distortion.

Ceramic rolling elements are non-magnetic and insulate against metal contact and electrical conductivity. Ceramic rolling elements also aid in noise reduction which reduces stress for the patients. Plastics are another material widely used for ball manufacture which offer many advantages for use in bearings. Light weight, corrosion resistant, cost effective, low noise are just a few benefits. Plastic materials are available that are self-lubricating and offer excellent wear and chemical resistant properties as well. FDA, USDA, NSF and 3-A sanitary compliance plastics can be specified for use in medical and food applications.

Tsubaki Nakashima produces a variety of plastic and stainless balls for use in the medical and industrial markets. We manufacture balls from over 80 specific types of materials including PA, POM, PAI, PC, PTFE, PP, PS,PE, and PMMA plastics in addition to 300/400 stainless steel series and tungsten carbides. These products often require specific tolerances and surface conditions (Ra) which are matched to the application specifications.

In keeping with environmental sustainability initiatives, plant based (Biomass) plastic materials are under increasing consideration to reduce dependence on fossil-based materials as well as for CO2 reductions. These highpolymer alternative materials are made from plant cellulose. One example is a bio-polyurethane ball with a partial biomass content, when in a rigid form is suitable for load-bearing applications.

To learn more about the ongoing developments in plastics and other raw materials under development, please visit http://www.tsubaki-nakashima.com/en/