Product Details

Pure Steam generator

As the pharmaceutical industry continues to grow and change, Machinfabrik strives to deliver superior quality products that are manufactured in accordance with cGMP. By choosing Machinfabrik Pure Steam Generator you are taking a proactive step in eliminating instances of a contamination thus safeguarding your company and the end-user from products that could be potentially harmful.
The sterilization process at the pharmaceutical industry requires high-quality pure steam with accurate pressure control and fast response times. Machinfabrik Pure Steam Generator is capable of producing pyrogen-free sterile pure steam that when condensed meets all USP requirements for use in steam sterilizers, critical area humidification, and routine SIP.

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Tech Specification

Injectable / Sterile Unit Pure Steam Generation Plant

All MACHINFABRIK WFI stills are designed to comply with ASME Pressure Vessel codes, current GMP norms, EN 285, USFDA, EU, PIC etc. The system will be provided with DQ, IQ, OQ documents.

The condensate of the Pure Steam complies with requirements of EN285, IP, BP, US FDA and EU GMP norms: -

The Pure Steam Generator consists of two columns – an Evaporator column and Separator column. The Evaporator column is a double tube sheet shell and tube type heat exchanger whereas the Separator column if fitted with entrainment separation system for pyrogen removal.

The Feed Water first enters a Pre-Heater where it is pre-heated. The Pre-heater is a shell and tube heat exchanger, which has Boiler Steam on the shell side and Feed Water in the tube side. The Feed Water then enters the Degassing Tank where the non-condensable gases are removed. The Feed Water then enters the Separator and Evaporator Column.

In the Evaporator column the Feed Water is evaporated. The generated vapor enters the Separator column where it is passed through an entrainment separation system consisting of multi-directional baffles and an inverted bell-cone separator for removal of water droplets and fine mist, which carry pyrogenic material.

The generated Pure Steam is condensed in a Sample Cooler. The Sample Cooler is fitted with a sampling valve and Conductivity Sensor for monitoring the conductivity of the Pure Steam condensate.

The Evaporator column, Separator column, Pre-Heater, Degassing Tank, Control Panel and all accessories are located on a skid for quick and easy installation. No foundation is required. Design also ensures customer has to connect utilities at a single point. The Skid is fabricated from S.S. 304 Stainless Steel square pipes using argon welding and is polished to a dull finish.

The Evaporator column, Separator column and Pre-heater are manufactured from SS316L. All welding is high quality argon gas welding executed by qualified welders using processes which comply with ASME standards and supported by necessary SOP’s and documentation.

The Evaporator Column is a double tube sheet heat exchanger. All Columns and Heat Exchangers are hydro-tested and inspected.

The Separator column is fitted with a sanitary sight glass to monitor the water level in the system.

The Evaporator and Separator columns are insulated with 25mm Rock Wool insulation that is encased in a SS304 cover with dull finish.
The system can be fitted with a Degassing system to remove the non- condensable gases from the Purified Water used as feed for the PSG.

The Sample Cooler is fabricated from SS316L and is installed at the outlet of the Pure Steam Generator. It condenses a small quantity of the generated Pure Steam using Cooling Water.

The Pure Steam condensate is monitored for conductivity. A sampling valve is also provided to sample the Pure Steam condensate.

An automatic on-off valve is provided in the Cooling Water line.

For removal of pyrogenic matter and ensuring there is no build up of impurities in the system the Evaporator and Separator column is provided with an automatic on-off valve. The user can set the on-off time.

All contact parts of the equipment are mechanically polished and then electro polished to a surface finish better than 0.3 m Ra value.

All non-contact parts of the equipment are mechanically polished to a surface finish better than 1.0 Ra value.

All process piping in contact with Feed Water, WFI and Pure Steam is of SS316L quality with high quality orbital welding. All other piping is fabricated from SS316 with argon welding. All fittings in contact with the feed water, WFI and generated Pure Steam are sanitary construction tri-clover fittings with Viton gasket / seals. All other fittings have threaded connection.

The process valves in contact with the Feed Water, WFI and Pure Steam are sanitary construction diaphragm valves with SS 316L contact parts with Teflon seat and having Tri-clamp connections. Necessary manual diaphragm valves are provided to ensure full drain ability when the machine is stopped.

The Steam to the machine is provided with an automatic control valve. The line is also fitted with an over pressure safety valve, pressure gauge and RTD Pt 100 Class A temperature sensor for low temperature monitoring.

The Feed Water to the system is pressurized with the help of a centrifugal pump. The line is provided with an automatic control valve, Flow Meter and conductivity sensor. The quality of Feed Water must comply with Purified Water as per USP.

The Cooling Water line is fitted with an automatic control valve.

The Compressed Air line is provided with a Filter Regulator Lubricator assembly to regulate the pressure and condition the air used for operation of the automatic valves.

All the drains and steam condensate are connected to a common header provided at a height exceeding 150mm above the finished floor level.

The functioning of the Pure Steam Generator is automatic and is controlled by a PLC. The PLC is operated with the help of a color, touch screen HMI with user-friendly features.

The PLC, instrumentation and electrical switchgear are housed in a SS304 panel installed on the skid.

For on-line process recording a data printer is provided in the control panel.

For ease of operation and safety of the operator all critical and non-critical alarms are displayed on the HMI as a text message and audio signal is provided via an audio buzzer.

Optionally, the following features can be provided in the system based on URS:- CE Marking, PID valves for steam and feed water, flow transmitter with VFD for feed water, utility isolation valves & gauges, boiler steam PRV, drain condenser, secondary cooling system, self-sterilization program, UPS, and pure steam testing kit.