Ethylene oxide is a very efficient sterilizing agent. It is a bactericide, a sporicide and a viricide. It has a very favourable diffusion coefficient and can be used for thermo-sensitive or very delicate materials.
Generally sterilization with ethylene oxide in the pharmaceutical industry has been restricted given the risk it entails due to its high mutagenic and carcinogenic properties. GMP’s specify that this type of sterilization should only be used when there is no alternative sterilization technology.
Nevertheless, the advantages of sterilization with ethylene oxide are still greater than those of any other system in the hospital single-use product industry. The leading companies in this sector still rely on ethylene oxide for the terminal sterilization of syringes, probes, catheters, pace makers, etc. The complex design of these types of medical devices makes the penetrability of the sterilizing agent one of the most critical aspects. It is in this area where ethylene oxide is far superior to any of the alternatives: hydrogen peroxide, peracetic acid, etc.
Since 1992, Telstar has delivered industrial scale EtO (ethylene oxide) sterilization plants which are ATEX certified, fully documented with appropriate Factory Acceptance Tests, Installation/Operation Qualifications and all other necessary requirements. Telstar can offer a broad range of solutions and services; from cycle development to automatic loading/unloading systems, parametrical release, EtO monitoring system, preconditioning chambers, degassing/aeration chambers and complete installation, commissioning and qualification of system, ancillary equipment and even utility services.
Telstar’s expertise and experience has been challenged globally in multiple projects developed on a turnkey basis with challenging demands from customers. The engineering and manufacturing practices for EtO installations follow ISO 9001 procedures as well as EN 1422, ISO 11135:2014, ATEX 2014/34/UE, FDA 21 CFR and GAMP guidelines. Design and construction in relation to safety and pressure vessels meet the most stringent regulations and codes from Europe, USA and other regions.
Whether the business is device manufacture or contract sterilization (CMO), the Telstar certified design can be readily adjusted to requirements by virtue of its modular design and construction,in accordance with the ATEX classification.
Telstar regards safety as a major priority and will always conform to the current ATEX regulations. The ATEX regulations apply to any installations under a potentially explosive atmosphere in Europe. In the USA the counterpart regulation is called NEC 500.
Three different types of studies are carried out on each project: Hierarchy of Risks, Risks Analysis (HAZOP) and Failure Mode and Effect Analysis (FMEA), which enables Telstar to obtain the official ATEX certification (09ATEX0001X) from the notified body INERIS (France).
A safety PLC is integrated for managing control of the entire installation in accordance to regulations required to comply with the SIL (IEC 61508) classification.
Telstar’s cycle software programming recognises the flammability diagram for EtO mixtures and avoids performing a recipe which has parameters that could result in an explosive mixture.
The use of degassing and pre-conditioning chambers can significantly reduce the EtO cycle time. Telstar provides customers the opportunity to install such a configuration, with a technology using high air circulation and removal, resulting in shorter process times.
The treatment of EtO after its use in the sterilization chambers is typically carried out with two types of technologies:
The advantages of acquiring this option are a significant time reduction for loading/unloading operations and operator ergonomics/safety.
Telstar can also provide a unique ATEX certified EtO IR detector, which is connected to the recirculation pipe and indicates the value of the chamber EtO concentration in real time.
Parametric release enables the product to be released to the market based on only process records instead of the traditional biological indicator sterility test. This is advantageous in that it eliminates the routine costs associated with biological indicators and laboratory testing.
The unit is supplied with our complete SCADA control system PharmaSter ®.
PharmaSter ® integrates the entire sterilization plant (comprised of all of the above modules or systems), located in a non-classified area.
This system includes an industrial PC with touch-screen colour display as optional. The software allows not only for supervision and control of the process, but also compiling, storing and processing the whole information in a batch oriented mode. The system is fulfilling 21 CFR Part 11 guidelines.
Actions posing a potential risk are controlled through an integrated PLC module, SIL certified, incorruptible and with restricted access.
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