Pharma Grade Superheated Water Sterilizers.
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.
The ASW Series is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMPs).
Reliable and Hygienic Construction
Chamber and internal door(s) are entirely made in stainless steel – different materials and surface finish variants are available. 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.
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.
Steelco has evolved its technologies to integrate its devices among themselves and into existing automation systems and, at the software level, to integrate naturally with the client’s software and customer management systems. We can install new equipment into an existing automation system by adopting a simple (HMI) or more sophisticated (SCADA) man-machine interface, with complete customization of access levels available. In compliance with the individual internal policies of each customer, Steelco offers remote service access by using virtual private networks to ensure the confidentiality and safety of all transferred data. Customized automation solutions that are wholly integrated with the client’s IS system and comprehensive network services such as integration with MES can be provided.
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 che 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 (IQ), 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.
Chamber size is from 830 to 25.000 liters (29 to 883 cu ft). Steelco Group is always available to customize machine dimensions upon customer-specific needs and requirements.
Optimal Temperature Distribution
Uniformity of temperature guaranteed by high capacity recirculation pump action.
Optimised for energy saving & low wastage with recirculation water cooling system.
The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
The onboard VPN router communicates with the PLC and the HMI on the local network. It allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
Only proven, non-proprietary, globally available components and automation systems. Steelco provides full details for every element allowing customers to source spare parts either from Steelco or the original equipment manufacturer.
Remote FAT service
In order to support the equipment verification procedures for our clients, we then introduce an alternative way to perform FAT – Factory Acceptance Testing, usually realized onsite. Remote FAT is a smart cloud-based service to support customers step by step in all procedures and testing and the production of related documentation that can be executed remotely, reducing the time required for staff to be away from the office and the associated costs including travel, accommodation, visa application, etc.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
from 830 litres / 29 cu ft
to 25.000 litres / 883 cu ft
Custom dimensions available upon request
The overall dimensions may vary according to machine configuration and customer requirements. Depending on space and operational requirements, an electrical cabinet may be installed remotely from the machine and steam generator.
Terminal Sterilization of Parenteral Drugs
A wide and customizable range of equipment to sterilize bulk and heavy drugs without damaging the packaging integrity. Optimized processing with maximum operational efficiency.