The increase of vaccines production boosts the demand of EtO sterilization chambers
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- Source: Telstar
- Date: 16 Mar,2021
Terrassa (Barcelona) 2021, March 16th. Telstar has expanded its engineering and manufacturing capacity due to the growing demand for EtO sterilization systems. It has increased the software and controls engineering team as well as a new assembly and testing area of 4.500 sqm. This area is fully devoted to EtO equipment to perform FATs of the complete lines with preconditioning cell, sterilization chamber and aeration cell including fully automatic loading and unloading systems. Most of the new lines will be installed in North America, European and Asian markets. All of them are ATEX certified and include integration with the air purification systems.
The growth in vaccines production, including the SARS-COV-2 vaccine, has increased the need of sterilization facilities for single use medical devices such as plastic syringes. There are several possible technologies to sterilize labile medical devices but the most common is using Ethylene Oxide as sterilizing media. Despite the inherent risks of this technology, it is robust and mature and as such has been widely used at industrial scale for more than 50 years (about 50% of all medical devices, including catheters and surgical mesh, in the U.S. are sterilized using EtO).
The main advantage of this technology is the high efficacy, penetrating capability, excellent materials compatibility, and low cost-in-use. This allows for the terminal sterilization of the packed medical devices laid in carton boxes, and the boxes forming a pallet ready to ship. Depending on the size of the sterilization equipment we can sterilize up to 32 pallets in a single batch. The combination of sterilization lines can give an important throughput of several million devices per day.
In general, a commercial EtO sterilization line requires a preconditioning chamber to control the temperature and humidity of the devices prior introducing them into the sterilization 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.
More than 40 years of experience has consolidated Telstar as one of the major leaders in the international market for sterilization solutions with EtO technology. The company is also specialized in solutions using depyrogenation, steam autoclaves and counter pressure autoclaves including robotic loading & unloading systems.
Telstar is a leading global brand of aseptic process solutions. The company has a consolidated activity in engineering & construction of complete turnkey pharmaceutical and biotech production facilities, critical installations, clean rooms, and R&D laboratories. Part of the azbil Group, Telstar is acknowledged as one of the 10 major suppliers to the pharmaceutical industry.