The Sterimega autoclaves are steam sterilization units designed for processing a wide range of materials: solid or porous products and also liquids in pharmaceutical production. The units offer high technical performance and GMP design in accordance with the applicable European standards: EN 285, PED, CE marking, etc. The standard unit can be customized by addition of various technical features that provide enhanced performance to address almost any requirement.
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Highly robust and reliable: rectangular cross-section chamber made entirely from AISI 316 Ti stainless steel and a AISI 316L stainless steel jacket, which completely surrounds the chamber and prevents condensation and improves excellent temperature distribution. The chamber is sealed with a silicone gasket which is located in a milled channel, needs no lubrication and is moved by pressurised air and vacuum.
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Ergonomics and flexibility: The loading and unloading logistics can be performed manually and fully automatically in the event of heavy and large loads. The automatic loading and unloading system consists of a rail system installed in front of the chamber entrance, where the trolleys or pallets are accumulated. The pallets, moving on skates, are introduced into the chamber by a mechanical traction system located underneath the rails. As an alternative to this system, the autoclave can be pit-mounted so that loading is performed at floor level by manual traction.
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Fully sanitary design: All the installation's necessary components and pipes (valves, connections, filters, fans, heat exchangers, pumps, etc.) are accompanied by quality certificates, in accordance with the standards required of a sanitary installation. Criteria for ensuring the equipment's long useful life and easy maintenance are also taken into account in the design and installation. These components should particularly be of a high quality; using only AISI 316L stainless steel, Tri-Clamp sanitary seals, pneumatically actuated valves, etc. An absolute vent filter for sterile air inlet, sterilisable in-situ, complete with connections for carrying out filter integrity test.
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Only sanitary designs permit use of and guarantee quality of steam, which must be a pure, dry and saturated sterilization medium. A typical load of solid or porous products is processed via a series of vacuum and steam impulses to extract the air and heat the product. The presence of air may put the sterilization efficiency at risk, and the vacuum integrity of the system is a very important aspect of the equipment. additionally, other types of loads, such as rubber stoppers in Tyvek type bags, liquids in semi-sealed or sealed containers, delicate filters, etc., require special care and the equipment needs to have special features to obtain the best results. The standard unit has the following options.
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Easy to operate: The standard control system is comprised of a PLC connected to a touch screen terminal. A 3-channel recorder and thermal printer complete the MicroSter control, supervision and recording system. As an option a SCADA system can be provided.