Introduction

PSG-E electrical pure steam generators are the same as the PSG but with electric heating: they are designed to produce clean or pure steam in accordance with the GMP established for the pharmaceutical industry by the FDA and the EMEA. Additionally, the equipment's technical specifications fully comply with the applicable standards: European guidelines for pressure vessels (PED), EN 258 (HTM 2010), ASME BPE recommendations for pharmaceutical process installations, CE marking, etc.

Description

The design of the equipment offers excellent performance for steam production for use in pharmaceutical production:

Sanitary design: The generator is designed in the form of a column, with the heat exchanger at the base and the expansion chamber above, which guarantees dry and saturated steam, free from droplets, which fall under the effect of gravity. The impurities are eliminated or intermittently drained from the base of the column.

All the active surfaces are mechanically polished to a surface roughness of Ra < 0.6 μm. The exchanger body is also electro-polished after mechanical polishing. All the detachable connections are joined with Tri-Clamp sanitary accessories and are supplied with FDA approved quality certificates. All welding is carried out in inert gas atmospheres using an automatic orbital method whenever possible.

Robustness and reliability: The electrical elements are made out of AISI 316L stainless steel and installed with sanitary connections. The column is thermally insulated with rock wool and it is clad with AISI 304 stainless steel sheet. The skid is made out of AISI 304 stainless steel.

Safety and easy operation: Operation is fully automated by means of sensors and the unit is equipped with the required safety and protection equipment, providing warning signals and alarms.

A PLC performs the control and management of the equipment. The equipment can be easily supervised and controlled by means of a touch screen in the control panel.

Quality guarantee: The unit is fully prevalidated in the factory to test its compliance with EN 258 (HTM 2010) standards in terms of saturation, heating and non-condensable gas levels.

Accessories & Options

• Pure steam condenser unit for the production of distilled water
• Degassing system
• Inlet water and pure steam monitoring
• Graphical recorder
• Condenser for sample taking
• Pressure reducing valve

Applications

Pure steam is defined as the steam which when condensed becomes WFI quality water in accordance with European and US Pharmacopoeia specifications. A generator capable of effectively separating pyrogens must be used for the production of pure steam. Clean steam is defined as the steam produced from water free from additives.

Pure steam is mainly used in the pharmaceutical industry and in biotechnology for autoclave sterilization feeding and for routine SIP sterilization in production reactors, freeze dryers, and production line filters and pipes.

Special Desings