AGS Series Ethylene Oxide Sterilizer

Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:

• cGMP
• GAMP 5
• FDA Regulation 21 CFR Part 11, 211, 820
• Eudralex
• ASME BPE
• PDA Technical Report
• European and US Pharmacopeia
• ISPE Guidelines
• UL and CSA (on demand)

Chamber volume
from 1 to 32 pallets

Custom dimensions available up on request

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.

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.

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.

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.