Ethylene Oxide Sterilizer
The AGS Series of sterilizers using Ethylene Oxide (EtO) represents the best relationship between engineering and quality price, operating running costs, and, most important, the safety of the system and operators. AGS Series has been designed for low-temperature sterilization of heat-sensitive products according to the EN 1422 Standards for the medical processing industry, such as plastic syringes, perfusion sets, dialysis cartridges, heat-sensitive rubber products, and specific surgical instruments.
This range of Ethylene Oxide sterilizers are available in two versions:
- AGS series | Pressure sterilization program – up to 10% of Ethylene Oxide, with the remaining 90% made of inert gas (normally Nitrogen)
- AGS-E series | Vacuum sterilization program – up to 90% of Ethylene Oxide, with the residual 10% made of inert gas (normally Nitrogen)
Following customer requests, dedicated chambers for separate processes can be supplied: Pre-conditioning, Sterilization, and Degassing chambers.
EtO sterilization process involves three different phases, which can be carried out within a single sterilization chamber or divided into three different work cells.
Pre-conditioning: The load undergoes a conditioning treatment to bring its humidity and temperature levels suitable for more efficient penetration of the EtO gas inside the product and its packaging.
EO Sterilization: Low-temperature sterilization by EtO / CO2 mixture injection at a pre-defined concentration.
Post-conditioning/Degassing: Necessary to remove any EtO particles from the product and packaging. Degassing is performed with a series of alternating vacuums and inlets of air at a controlled temperature.
In the case of separate load cells, automatic loading/unloading systems are required allowing the operators to save time and avoid exposure to a potentially contaminated environment.
Highest Industrial Standards
A high-efficiency heating jacket surrounds Steelco’s rectangular cross-section sterilization chamber for rapid and even heating of loads. The machine body is AISI 304 stainless steel, insulated with high-density ceramic material and a clad stainless steel sheet. The chamber and the hydraulic system are entirely built and clad stainless steel. Process piping is made of tri clamps and flange connections.
High Productivity, Low Consumption
The new range of sterilizers has been designed for best-in-class energy recovery to optimize consumption. The vacuum system is provided with a water ring pump, supplied with water drawn from the separator by creating a closed circuit. The temperature is maintained at optimum levels by a heat exchanger. The pump outflow is directed to the separator, from where it is sent to the neutralizing system. The air supplied into the chamber in the degassing phase is filtered through absolute filters to guarantee higher quality.
Complete Enviroment Protection
Effective and safe abatement of Ethylene Oxide at the completion of sterilization process by thermal combustion: increasingly stringent parameters make it necessary to offer safe accepted abatement systems on every Ethylene Oxide sterilizer. Steelco Group follows the ATEX, UL, OSHA, NFPA, and FDA regulations and complies with ISO 11135, EN 1422.
From 1 to 32 pallets chamber size. Steelco Group is always available to customize machine dimensions upon customer-specific needs and requirements.
Safe Door Closure
Safe hermetic closure guaranteed by a pressure-sealing device with automatic tie-rods. Pneumatically pressurized gasket with a 4 year of warranty.
Environment and Safety
Effective and safe reduction of Ethylene Oxide at the completion of sterilization process by thermal combustion.
Fully automated transfer systems with fixed rails within the chamber for loading and unloading pallets are available to optimize workflow and maximize productivity.
The onboard VPN router communicates with the PLC and the HMI on the local network. It allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
Only proven, non-proprietary, globally available components and automation systems. Steelco provides full details of every component allowing customers to source spare parts either from Steelco or from the original equipment manufacturer.
Remote FAT service
In order to support the equipment verification procedures for our clients, we then introduce an alternative way to perform FAT – Factory Acceptance Testing, usually realized onsite. Remote FAT is a smart cloud-based service to support customers step by step in all procedures and testing and the production of related documentation that can be executed remotely, reducing the time required for staff to be away from the office and the associated costs including travel, accommodation, visa application, etc.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
from 1 to 32 pallets
Custom dimensions available up on request
Low Temp Sterilization of Medical Devices
Huge volumes of heat and moisture sensitive medical devices can be sterilized with Ethylene Oxide gas. Steelco offers a range of sterilizers of different capacities, which can be customised according to the client’s needs, equipment for time-saving pretreatment, safe EO gas disposal, and automated loading and unloading systems to ease the entire workflow.