AGS/AGSE Series - Chemical Sterilization
- The machine body and jacket are completely made of AISI 316L stainless-steel.
- AISI 316L stainless steel piping is connected with ASME tri-clamp connections.
- The machine body is insulated with ceramic material and with an external cladding of stainless steel.
- Effective and safe abatement of Ethylene Oxide at completion of sterilization process by thermal combustion.
- Pneumatic control of the valves.
- A safe hermetic closure guaranteed by a pressure-sealing device with automatic tie-rods.
Pressure sterilization program up to 10% of Ethylene Oxide, with the remaining 90% made of inert gas (normally Nitrogen)
Vacuum sterilization program
up to 90% of Ethylene Oxide, with the residual 10% made of inert gas (normally Nitrogen)
Complete protection of the environment
Abatement of Ethylene Oxide at completion of sterilization process: increasingly stringent parameters make it necessary to offer safe accepted abatement systems on every Ethylene Oxide sterilizer. Steelco Group follows the ATEX, US, OSHA, NFPA and FDA regulations and complies with ISO 11135, EN 1422.
Compliance and guidelines:European Directives: 2006/42/EC; 2004/108/EC; 2006/95/EC; 97/23/CE; ATEX 94/9/CE. European Standards: EN 12100-1-2, EN 13857, EN 349, EN 61000-6-II-IV, German version EN 61000-6-4; EN 55011 (ISM); EN 61000-4-II-IV (IEC); AD 2000; EN 60204-1 (IEC 204.1); EN ISO 11135; EN 1422. North American Standards: OSHA; NFPA (when applicable: FDA; UL; ASME). Canadian Standards: CSA; CRN. Russian Standards: GOST.
Software is developed in compliance with current coding rules and programming and according to standard ISA 88, ISA 95, IEC 61131-3 standard & GAMP 5.