Feb. 13, 2012
/PRNewswire/ -- Ashland Specialty Ingredients, a commercial unit of Ashland Inc. (NYSE: ASH), has chosen Web Industries, Inc., a global leader in custom manufacturing and development services for flexible materials, to manufacture its Rad-Sure line of blood irradiation indicators. This partnership will allow
to see increased production yields and reduced defect rates over the lifespan of the contract for the blood-supply safety devices.
's Rad-Sure blood irradiation indicators are used to quickly and clearly verify that blood components have been irradiated to protect patients from contracting transfusion-associated graft-versus-host disease (TA-GVHD). This is a rare, but potentially fatal, complication associated with blood transfusions in which the blood donor's lymphocytes engraft in the recipient. Certain categories of patients – such as those with solid tumors, acquired T-cell deficiencies and bone marrow transplant recipients – are more prone to contracting the disease. Proper irradiation of the blood before transfusion destroys the donor lymphocytes and prevents the immunoreaction that leads to TA-GVHD.
Rad-Sure is a complex, multi-layered laminate device that is affixed to transfusion blood bags. It features a gamma-ray or X-ray sensitive indicator that displays a clear "NOT IRRADIATED" message until exposed to the proper level of radiation. Once exposed, the "NOT" becomes obscured and the visual message reads "IRRADIATED," providing quick, positive visual verification.
To manufacture Rad-Sure, Web Industries'
facility had to develop manufacturing methods to pre-process and combine multiple web-based raw materials into discrete subassemblies and then precisely combine those subassemblies to create the finished medical device. The final assembly process involves in-line lamination, fixed and variable-data printing using either thermal or flexographic processes, and precision die cutting and island placement. Web's manufacturing solution reduces risk with automated inspection and data logging, substantially increases capacity, and improves the yield of high-value input materials.
All assembly takes place on one of Web Industries' modular, programmable manufacturing lines in a medical Class 10,000 clean room environment. An automated vision inspection system capable of measuring tolerances down to +/- .005" and performing optical character recognition to verify the presence and accuracy of lot numbers and language keeps a watchful "eye" on the devices as they move through the process. This monitoring system inspects 100 percent of the critical-to-safety features of Rad-Sure, with real-time data monitoring and automatic detection and segregation of out-of-spec products onto a defect conveyor.