Puretech’ pure steam generators are engineered to deliver dry saturated pyrogen free steam in compliance with full cGMP guidelines in line with FDA and EMEA requirements.

Puretech’s engineering and manufacturing practices follow ISO 9001 procedures, ASME BPE criteria, GAMP guidelines. Design and construction meets the most stringent regulations and codes from Europe, USA and others concerning safety and pressure vessels.

Pure steam generation at almost any capacity can be achieved with a stand-alone unit or with simultaneous production of water for injection with our Combi units.

Effective design

Low steam velocity and droplet separation

Low steam velocity in combination with cycloning in multi-effect distillation improves the WFI quality and drastically reduces the risk of carry over of droplets and particles to the clean side.

Float type heat exchangers 

The heat exchangers used are fully submerged in the boiler water ensuring tensionless operation and no dry spots thereby avoiding micro cracks and material exhaustion.

The design allows for the equal expansion/contraction of the materials.

Proportional media regulation

Automatic regulation of water and steam ensures trouble-free operation even in changing conditions e.g. during simultaneous COMBI production of WFI and pure steam.

Flexibility and capacity

Puretech pure steam generation systems can be tailor made to individual requirements.

High accessibility for servicing

The skid mounted units are designed for easy access and servicing of all components.

 

Quality assured

To ensure the equipment meets each client’s requirements a dedicated team manages each project. Our specialists and technical team provide support from design through installation and commissioning to validation, with after sales service to guarantee trouble free production. We develop specific quality plans (DQ, IQ and OQ) and all units undertake factory acceptance testing (FAT) before delivery to give assurance of performance and quality. The documentation is complete for the validation of the equipment on site. Units and systems are installed, commissioned and validated by our specialists. Site acceptance testing (SAT) documentation with IQ/OQ is supplied on completion of each installation.

What is pure steam and how is it used?

Clean steam is defined as saturated steam produced from additive-free water, relatively free from non-condensable gases. When pure steam is condensed it meets the USP and EU Ph standards for WFI, which state that endotoxins level is typically below 0.25 Eu/ml.

Clean steam should be used when the steam or resulting condensate comes into direct or indirect contact with any medical device or pharmaceutical product. It is the ideal heat transfer media for carrying out sterlization and/or sanitization processes in autoclaves, tanks, reactors, pipe systems etc.