Plasmapp Co., Ltd., an innovative company developing plasma-tech for underserved medical and industrial markets focusing on sterilization and product manufacturing, is showcasing the world’s fastest sterilizer, STERLINKTM at the 39th of the ESCRS Congress.
STERLINK is a novel plasma sterilizer for medical devices. The technology of STERPACK® packaging pouches enables the fastest sterilization cycle time at low temperatures.
This highly improves medical device usage because fast cycle time enhances efficiency and low temperature ensures minimum damage to the device.
Furthermore, plasma sterilization is free from toxic EO gas, making the process eco-friendly and harmless. STERLINK’s safety and reliability as medical equipment is proven by FDA approval in 14 countries.
Description on STERLINKTM
The need for appropriate disinfection is emphasized by various occurrences resulting from improperly decontaminated patient-care items. Various sterilization methods are used in hospitals and clinics which are normally categorized into physical and chemical sterilization.
The physical sterilization is considered as the most reliable sterilization method for the items that can withstand heat, and this sterilization method is applicable to both moisture-sensitive and moisture-resistance products, for which dry (160 – 180oC) and moist (121 – 134oC) heat sterilizers are respectively used in hospitals and clinics.
The low-temperature chemical sterilizer was developed for reusing heat sensitive medical devices where the sterilization cycles are processed by utilizing chemicals such as ethylene oxide (EO) and hydrogen peroxide. The EO gas is used as a sterilant of the low-temperature (37 – 63oC) chemical sterilizer since 1950s, and it was considered as a representative chemical sterilization method.
Although the EO gas sterilization produces the effective decontamination for various medical devices at low temperature, the hospitals and clinics are gradually reducing the use of this kind of the toxic sterilization method. The toxic sterilant requires long purification process after its sterilization cycle, and overall sterilization cycle normally takes about 10 hours.
A hydrogen peroxide low-temperature sterilization (normally 55oC) was developed and commercialized in 1990s, in which the sterilant of hydrogen peroxide gas provides a robust antimicrobial activity in a wide range of microorganisms such as bacteria, yeasts, viruses, and bacteria spores.
The sterilant of hydrogen peroxide is not toxic and does not leave significant residues on the sterilized devices which can be handled safely either for immediate use or storage without long purification process.
The hydrogen peroxide is vaporized at temperature of about 150oC under atmospheric pressure, but the temperature can be reduced to about 45oC by processing at vacuum condition (less than 50 torr for the hydrogen peroxide sterilizer).
It is noteworthy that this temperature and pressure condition is critical for the sterilant to be in gas phase which secures the sterilization performance of the hydrogen peroxide sterilizer.
A novel sterile pouch of STERPACKTM has been developed by Plasmapp, and the impermeable pouch improves the heating process and sterilization efficiency. A key feature of the impermeable pouch is that the pressure and the pouch and chamber can be controlled independently during a sterilization cycle.
It is noteworthy that the sterilization process is rapidly completed which is experimentally found to be related with the pouch compression which is a pressure peak in each sterilization phase.
The pressure peak is resulted by increasing pressure of the chamber while the pouch is isolated, and the compression pressure is parametrically investigated to obtain the optimized condition for enhancing sterilization efficiency.
The sterilization cycle was investigated experimentally and numerically, and the overall sterilization cycles are also validated by using a process challenge device (PCD, diameter of 0.7 mm and length of 500 mm) whose overall sterilization cycle is completed within 7.5 min.