Plazmap, World's First Ultra-Fast Sterilization Pouch 30 Times Faster... Certified by US FDA

Bio plasma deep-tech company Plasmap announced on the 11th that it has obtained U.S. FDA certification for the sterilization pouch using the world's first non-permeable film (brand: STERPACK), enabling ultra-fast low-temperature sterilization processes for sterilizers.

Plasmap has enabled the ultra-fast sterilization mode on its low-temperature plasma sterilizer (model: STERLINK FPS-15s plus), which has started sales in the U.S. medical device market, by obtaining FDA certification for the STERPACK pouch. This is expected to increase the turnover rate of expensive medical and surgical devices by more than 30 times, enhancing competitiveness in the U.S. medical device market and accelerating expansion into overseas markets including the U.S.

Considering that Plasmap's ‘STERLINK’ was the only small sterilizer certified by the FDA in the U.S. market, it appears to be creating a super-gap in terms of maximizing equipment operation efficiency.

Plasmap’s STERPACK began with the technology transfer of plasma sterilization from KAIST and independently conducted research and development to successfully commercialize the world’s first medical sterilization pouch using a non-permeable film. It has filed and registered numerous global patents and received the Ministry of Trade, Industry and Energy’s New Technology Certification (NET) and Innovation Product Award.

Plasmap CEO Lim Yubong stated, "Through U.S. FDA certification, we have verified the safety and efficacy of Plasmap’s sterilization technology, which is more than 30 times faster than existing low-temperature sterilization technologies," adding, "We will focus on research and development to establish Korea’s core technology as a new standard in the global medical device market and create a technological super-gap."

In addition to the U.S., Plasmap has proven the safety and efficacy of its ultra-fast low-temperature sterilization technology in the global market by obtaining medical device certifications in 15 countries. With the full-scale entry into the U.S. market, overseas market expansion is accelerating.

Plasmap plans to continue pursuing global overseas certifications, securing customers in the market based on these, and further expanding the overall market for sterilization solutions. Industry insiders expect that Plasmap’s diverse certification acquisitions will help control indiscriminate market entry alongside market expansion.

Plasmap CEO Yoon Samjeong said, "The U.S. FDA certification is expected to bring innovation to the medical device market in the U.S.," adding, "Rather than focusing on sales of individual sterilizers, we have built a sterilizer portfolio with various sizes certified by the U.S. FDA." He continued, "It is possible to operate a sterilization solution consisting of sterilizer-consumables-warranty," and positively forecasted, "Since major U.S. customers have long awaited FDA approval of the STERPACK pouch, this certification will accelerate entry into the U.S. market."