Document qkZB7Bkx7vdMkm5OQ2Q76vZa5

Application Number: E2.9_Fluororesins for medical device applications Fluororesin used: PTFE (CAS No. 9002-84-0) Product overview: Gasket for prefilled syringe (sliding stopper) A fluororesin film is used in a gasket for a prefilled syringe for medical device applications. A fluororesin film is used after heat-coating and processing. Since pharmaceuticals are filled into this and stored over a long period of time, it is necessary that the coated sliding stopper slides smoothly without substances being eluted therefrom. For this reason, specifications such as slidability, heat resistance, elongation, purity, and inactivity are required, and a fluororesin is adopted as a material that satisfies all of these required specifications. At present, a substitute product that satisfies all of the above-described requirements at the same time has not been found. Since a prefilled syringe can be filled with a required amount in advance and stored over a long period of time, the work up to administration when in use is simplified and the risk of infection, foreign matter contamination, medical malpractice, and the like is reduced. 1 In addition, prefilled syringes in which films other than fluororesin films are used have insufficient lubricity and may interfere with safe inoculation work. The global market size of prefilled syringes is expected to be USD 622.9 million in 2021 and is expected to grow at a compound annual growth rate of 10.9% from 2022 to 2030 (2030 forecast: USD 15.815 billion). In such a great need, it is thought that the shift to alternatives from fluororesins, which is very difficult to realize, will have a significant negative impact on the medical industry and humanity. As described above, permanent exemption from the proposed restrictions is proposed for this use. Typical properties of fluororesins are shown in the following table. 2 Reference material: VALQUA Handbook Technical Section 3