MIELE Group member

 
AMS Series - Terminal sterilization

This methods of sterilization avoid any damage of the processed liquid material and their containers, including heat sensitive materials. Thanks to an effective recirculation of air, uniform temperature is maintained in the sterilizing chamber during all process phases.

Required pressure balance is achieved by using sterile compressed air in the chamber. The process includes the application of counterpressure to avoid permanent deformation of containers.

Pure steam is used in the chamber for heating liquids and over-pressure filtered air is injected into chamber to compensate for the rising temperature and pressure inside products. Internal fans ensure a uniform temperature distribution, between 110°C to 135°C, and to avoid cold spots across the chamber. Rapid heating and cooling are standard phases. Products are completely dry at the end of the cycle.

Chamber volume
from 830 litres / 29 cu.ft
to 25.000 litres / 883 cu.ft

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    • 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.
    • This system ensures the seal of the door in any condition of operation.
    • Unique sealing of fan shaft for easy inspection and maintenance.
    • Flexible RTDs.
    • Equipment is provided with a grounding lug for proper static grounding and seismic compliance if required.
    • The front loading side the machine is provided with the connection ports required for the validation tests.
    • The control system PLC is capable of storing and executing preprogrammed cycles and performing all self-diagnostics cycles.

    Versatile loading/unloading systems and automation: Steelco can provide a range of automated solutions including integration with robotic systems.

    Useful combined solution
    Steelco Group designs combined/modular systems sterilization, where heating and sterilization phases are carried out with saturated steam, like a normal sterilizer, or with a mixture of steam and air in the same autoclave.

    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.

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    1_Pharma, catalogue sterlizers

    Catalogue

    2_Pharma, intro catalogue

    Brochure

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