Telstar has expanded its engineering and manufacturing capacity due to growing demand for EtO sterilisation systems. It has increased the software and controls engineering team and built a 4500 sqm assembly and testing area. This area is devoted to EtO equipment to perform FATs of the complete lines with preconditioning cells, sterilisation chamber and aeration cells including automatic loading and unloading systems. Most of the lines will be installed in North America, European and Asian markets. All are ATEX certified and include integration with the air purification systems.
The growth in vaccines production, including COVID-19 vaccines, has increased the need of sterilisation facilities for single use medical devices such as plastic syringes. There are several technologies to sterilise labile medical devices but the most common is using ethylene oxide (EtO) as sterilising media. Despite the risks of this technology, it’s robust and mature and as such has been used at industrial scale for more than 50 years.
The main advantage of this technology, Telstar says, is high efficacy, penetrating capability, excellent materials compatibility, and low cost-in-use. This allows for the terminal sterilisation of the packed medical devices laid in carton boxes, and the boxes forming a pallet ready to ship. Depending on the size of the sterilisation equipment, up to 32 pallets can be sterilised in a single batch. The combination of lines can enable a throughput of several million devices per day, the company says.
In general, a commercial EtO sterilisation line requires a preconditioning chamber to control the temperature and humidity of the devices prior introducing them into the sterilisation chamber, the chamber itself and an aeration chamber to reduce the EtO residuals to a safe ppm level. The gas should be treated in an air purification system to prevent emissions of ethylene oxide into the atmosphere.