FDA-compliant off-the-shelf linear motion components for urgently needed medical products

In dealing with the COVID-19 pandemic many companies have volunteered or been requested to produce urgently needed medical products such as masks, gowns, and ventilators. Tooling up quickly to produce medical grade products for some companies can bring challenges. In addition to needing FDA-compliant materials that will be used in the actual masks, gowns, and ventilators, the tooling used to manufacture these products may also need to meet FDA compliance standards. Depending on the product being manufactured, the tooling may need to be washed down using caustic chemicals, cleaned with high-pressure steam, or sterilized with high Intensity ultraviolet light or radiation.

Ordering custom FDA-compliant linear motion slides and XYZ stages can result in long delays. As an alternative, many companies have linear motion slides in stock for immediate delivery; however, they may not be FDA compliant. In many cases it’s the bearings that are not in compliance.

LM76 manufactures several types of FDA-compliant linear bearings and pillow blocks that are drop-in-replacements for existing bearings. FDA compliant bearings and pillow blocks from LM76 will not trap contaminating debris and can be thoroughly sanitized following Sanitation Standard Operating Procedures (SSOPs). SSOPs are detailed schedules and procedures specifying what to clean, how to clean, how often to clean, and the record keeping used for monitoring.

A helpful component selection guide from LM76, “Linear Bearings, 6 Simple Steps – FDA Compliance, Wash Down Compliance,” details the linear motion components available from LM76 that are FDA/UDSA/3A-Dairy compliant. Included are: Foodstream electroless nickel-plated pillow blocks, PTFE lined stainless steel bearings, ceramic coated linear bearings, self-aligning corrosion-resistant linear ball bearings, and Thomson Super Smart corrosion-resistant, self-aligning, high load linear ball bearings, and solid ETX pillow block/bearings. Shafting to compliment the type of bearing selected includes: Class L Stainless 303/304/316, 440C case hardened stainless, Rc 60 case hardened steel with an Armoloy coating and also Rc78 Class L for enhanced hardness and wear resistance. End blocks and shaft supports that have a ceramic or electroless nickel coating are also available, as well as new ETX Scraper Seals that prevents intrusion of contaminates adding another line of defense.

LM76 also designs and custom builds linear slides from stainless steel and other FDA wash down compliant materials.

For more information, visit www.lm76.com.