The critical issues that a pharmaceutical and biotechnology company faces include the need to ensure compliance with severe quality and safety standards required by the authorities, the efficient management of complex production processes, the constant control of contamination and the reduction of operating costs. Furthermore, the guarantee of a constant supply of hot water for injection and pure apyrogenic steam is essential to maintain the integrity of sensitive manufacturing processes and to ensure the safety and effectiveness of products intended for human use.
To meet these needs, Veolia Water Technologies has developed the new generation of PolarisTM 2.0, composed of a multiple effect distillation system (MED - Multiple Effect Distiller) for the production of hot water for injection and a system for the generation of pure apyrogenic steam (PSG - Pure Steam Generator).
The new PolarisTM 2.0 range has been designed to provide the necessary volumes of water for injection and pure steam, in line with European, Japanese and US pharmacopeia standards, and includes a set of standard models with different capacities and a list of options designed to satisfy every clients’ requirement. In addition, the new PolarisTM 2.0 units are compliant with the guidelines FDA CFR 21 Part 11 and GAMP V.
With PolarisTM 2.0, pharmaceutical companies can be sure of using reliable and innovative products for the production of pure apyrogenic steam and hot water for injection. Investing in PolarisTM 2.0 means adopting an approach oriented towards quality and regulatory compliance, ensuring maximum safety and reliability in the pharmaceutical production process.