Single-use bioreactor providing a family of single-use bioreactors from bench-top to full-scale production. Three challenges exist for faster and greater single use bioreactor adoption 1) higher quality and lower cost disposable bags and containers, 2) more reusable and disposable sensors and probes that can provide high quality analytics including real-time cell culture level data points, and 3) a family of bioreactors from lab to production that has full scale-up of the bioprocess. Suppliers are working to improve plastic bag materials and performance and also to develop a broader range of sensors and probes that provide scientists greater insight to cell density, quality
Single Use Medical Device Reprocessing these reprocessed devices on the market, under the condition that third-party reprocessors would be treated as the manufacturer and would meet the same criteria as the original equipment manufacturers (OEMs) of the medical device. Following the implementation of FDA regulation, the U.S. Congress codified these standards and other requirements in the Medical Device User Fee Act of 2002. Original equipment manufacturers undergo a thorough analysis to determine whether a device should be single-use or reusable. Factors in determining to label a device single-use include but are not limited to possible infection/sterility concerns and the risk of reduced efficacy. Depending on