The Challenge
Turner Innovations developed ClearShield – a new transparent, lead-free customized acrylic sheet for x-ray shielding. Turner Innovations needed a manufacturing partner to transition ClearShield into production, with plans for initial production of 12mm (~1/2”) thick sheets (0.5mm lead equivalence).
The Solution
Turner MedTech, an ISO 13485 certified manufacturer and subsidiary of Turner Innovations, was a proud partner in the process development and transfer of ClearShield to production. Key functions performed by Turner MedTech in both phases of this development process included Process Development and V&V testing, and ultimately performed all production functions from sales and marketing to production and order fulfillment upon completion of development.
Turner MedTech applied their expertise in all the areas circled in the chart above. Due to extensive equipment requirements for ClearShield production, the Equipment Planning and Process Validation development support activities required considerable attention. Key equipment requirements included:
- Exhausted chemical storage room
- High shear mixer
- A reactor mixer with temperature control
- Casting molds
- Material handling equipment
- Final testing equipment for thickness testing, visual inspection, and lead equivalence testing
Turner MedTech coordinated with Turner Innovations to define equipment requirements, then executed the procurement, design, and assembly of the equipment, followed by IQ/OQ/PQ planning and reporting.
The Result
ClearShield, in a size of 12mm x 700mm x 900mm (~28” x 35”) was commercialized in 2016, adding a lead-free x-ray shielding option to operating rooms, clinics, and other applications to keep medical and dental staff safe from x-ray exposure. The Equipment Planning and Process Validation activities were repeated in 2017, making ClearShield available in 12mm sheets as large as 1m x 2m (39.4” x 78.7”). After 5 years of commercial production of ClearShield by Turner MedTech, the product line was sold. It is now owned and produced by FT ClearShield in Bessemer, Alabama.