Industry 4.0 and the increasing prevalence of contract manufacturing pharmaceutical companies (CDMOs) have led to a market need for versatile and efficient sterilization solutions.
In demand are machines capable of handling different load types within a single system. RSA Premium, developed by LAST Technology, is an innovative answer to these needs. This machine combines in itself the ability to sterilize various forms of cargo, both solid and liquid, using different methods and managing to offer an integrated solution that optimizes production processes and reduces costs.
Versatility and Innovation
RSA Premium is designed to meet the growing need to process and handle different materials in a single machine. This solution is key to containing production costs and optimizing production layouts, especially in an industry such as pharmaceuticals, where processes must be highly customizable to specific products.
RSA Premium combines three sterilization processes into one system, using moist heat that harnesses water in both liquid and gaseous form to generate thermal energy. The three main processes are:
- Saturated steam: ideal for solid loads, saturated steam yields a large amount of thermal energy to the load. The process involves vacuum and pressurization steps to reach and maintain the desired temperature, followed by effective cooling and drying.
- Air + steam: suitable for liquids in sealed containers, this process heats air by steam injection and uses fans to ensure even temperature distribution. Cooling is done with exchangers, balancing the containers‘ internal overpressure with sterile air.
- Superheated water: perfect for injectable solutions in plastic containers, superheated water irrigates the load while maintaining temperature via heat exchangers. The cooling phase uses the same water, cooled through exchangers.
Technical characteristics and compliance
The chamber of RSA Premium is made of AISI 316L for the surfaces in contact with the process fluids, while the external structures are made of AISI 304. Two external exchangers heat or cool the water during the superheated water process, and four internal exchangers control the temperature in the air + steam process. Two fans ensure perfect homogenization of the air + steam mixture.
To ensure reliability, the machine is equipped with safety valves, pressure and level sensors, pressure transducers and temperature probes. These devices are distributed at strategic points in the machine for precise control of the progress. Process water can be discharged or reused, improving efficiency and reducing environmental impact.
The RSA Premium design meets CE, Eudralex, FDA and cGMP regulations, ensuring that each machine meets the highest standards of quality and safety. The design of the chamber and the entire machine takes into account temperature (-10 °C to +143 °C) and pressure (-1 to +3 bar) conditions, classifying the machine in Category III according to the 2014/68/EC regulations.
RSA Premium represents a significant breakthrough in sterilization technology, offering a versatile and integrated solution for handling different types of loads in a single machine. This innovation meets the needs of an ever-changing industry, ensuring efficiency, safety and compliance with international regulations.
