Superheated water sterilizers for pharma industry
Steelco’s range autoclaves using superheated water are for the terminal sterilization of injectable solutions. This sterilization method avoids damage to the processed liquid material and their containers, including heat-sensitive materials. It is used to sterilize liquids in sealed or heat-sensitive containers such as bottles, ampoules, vials, semi-open containers, infusion bags, blister packing, pockets, contact lenses, LPV’s, etc., and also for the pasteurization of products like blood plasma.
The ASW Superheated Water Sterilizer is available in several chamber sizes – chamber volume ranges from 830 to 25.000 liters (29 to 883 cu ft) – with the possibility of customizing dimensions upon customer-specific requirements. The chamber is equipped with horizontal sliding double doors, and an electromechanical device controls the movement. A gasket guarantees the door tightness in Silicon FDA compliant swallowtail pneumatically pressurized by compressed air.
Reliable and hygienic construction
Chamber and internal door(s) are entirely made in AISI 316L stainless steel. Sterilization chamber of round cross-section, containing all the accessories for its use with superheated water. The design of the lower part of the chamber allows complete drainage, and it is fitted with guides for moving the product holding carts. All piping in AISI 316 L stainless steel, orbital welded (where possible) for sanitary applications, respecting 1% slope (if applicable). FDA components in contact with the product are of sterile type - a 3.1 certificate can be provided.
Sterilization process
Water is continuously circulated through the system and cascades over the load using spray nozzles, a high capacity pump, and large diameter piping to ensure high water flow rates. The recirculating water is heated and cooled by external heat exchangers. Meticulous control of heating and sterilization is achieved by superheating the water using modulated steam. Compressed air at overpressure is injected to compensate for the rising temperature and pressure inside the products when heated. The cooling phase brings the product down to ambient temperature by continuously spraying the recirculating water over the load.
Workflow optimization and load handling
Steelco's extensive experience assists customers to increase process productivity and quality with improved ergonomics whilst limiting costs. Semiautomatic or fully automated conveyor systems for loading and unloading of racks and integration with robots are available to optimize workflow and maximize productivity. Loading racks completely made of AISI 316L stainless-steel equipped with guide for shelves positioning can be provided of automatic push and pull device guides to be installed inside the chamber.
Quality engineering process and qualification services
Our equipment's technical consulting, design, engineering, project management, and commissioning and qualification services are offered, with customers appreciating the cost-effective, high-performance solutions provided to resolve complex washing and sterilization challenges. Design qualification (DQ), Installation Qualification (10), Operational Qualification (OQ), and Performance Qualification (PQ) are provided in a standard version or customized according to the final scope of supply. In addition, customers are always welcome to visit Steelco factories to see design and manufacturing methods and audit our processes.