Safety is a part of any pharmaceutical industries that cannot and should not be downplayed.
The same is true with ethylene oxide sterilisation equipment. Ethylene oxide is a gas with many sterilising virtues but its danger cannot be denied, so the process control and the proper choice of equipment and materials are essential to guarantee optimum safety.
When we talk about safety with ethylene oxide (EO or EtO) sterilisation plant, we are mainly referring to the safety of the process and its proper operations to achieve correct product sterilisation, protecting everyone’s health. Also, we talk about the installation safety itself and obviously of the plant workers.
The issue of security is present from the very beginning of an EO sterilisation project until its full completion. The key is to take it into account at every moment of the project development and consider it as a priority, not an option.
Safe Sterilisation equipment
Safety used to be directly linked to quality, and in this case, it is so. That is why it is essential to choose equipment with state-of-the-art technology, including high quality and accurate components, materials and instruments to achieve a high level of excellence.
For example, measuring instruments for EO concentration, humidity level, pressure has a role in this process. Their values have to be accurate and reliable to guarantee proper operations of the process and equipment.
Also, the materials and the design of the industrial autoclave have to be adequate and should let the sterilisation process to be carried out in the best conditions, without to come up against design errors or inappropriate materials.
PLC and SCADA control system
The whole part of the control system is undoubtedly one of the fundamental points in sterilisation equipment. Therefore, a validated SCADA with a well-programmed PLC are the keys to ensure correct operations.
For perfect control of the sterilisation process, the control system must be installed and programmed according to detailed risk analysis and based on the client’s requirements, to get optimal and safe equipment. Not any control system could be used in fact, as it must be a SCADA technology due to the complexity of the process.
Also, it should comply with the HAZOP and SIL analysis defined in each project. To meet the safety level that the pharmaceutical sector requires, it has to fulfil several characteristics such as:
• GAMP 5 and 21 CFR part 11 for electronic records.
• Validated Software (SDS, SMDS, SMTS)
• A complete synoptic with alarms, graphs visualization
• Cycles reports
Facility Security
The risk of explosion is always present with industrial ethylene oxide sterilisation equipment and they cannot be installed just anywhere. The facility they should be located in must meet certain safety requirements according to the local directives (ATEX in Europe, NEC 500-505 in the US) and must use safety devices like sprinklers, gas detectors, forced ventilation to control, to prevent and reduce damages in case of hazard situation. It is important not to save money as the consequences could be devastating.
Protect the environment with a catalytic system
Environmental issues are important and we must take the subject into serious consideration.
Ethylene oxide is a harmful gas for health and the environment. It is important to choose an air purification system that minimises damages on the environment and person.
Recently, several EO emission issues have been detected in the United States in well-known companies, showing industrial equipment for EtO sterilisation must be developed to reduce as much as possible the gas particles released in the air.
Today, the most famous processes for air purification systems are:
• Scrubber
• Catalytic system
As experts in ethylene oxide sterilization, we are always in favour of the installation of an effective catalytic system. This technology, if well designed, succeeds to eliminate almost all the ethylene oxide, ensuring less than 0.5mg / m3 of emissions to the atmosphere, and then complying with the strictest international regulations, the TA Luft.
Betting on safety usually means to invest for equipment and solutions having a high quality, reliable and advanced technology.
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