Product Details

Thermocompression Distiller

All Pharmaceutical production processes require a stable & consistent supply of quality-controlled water for applications ranging from non – critical processes to product formulation. Highest quality WFI due to strong degassing.

Machinfabrik’s Thermocompression Distiller is designed and constructed to produce sterile and pyrogen-free water (WFI) with critical emphasis on quality and cost.

This sterile & distilled water meets the requirements of the International Pharmacopoeias including USP, EP, & is used for various pharmaceutical applications such as I.V. solutions, injectables, washing systems & some special solutions where both quality factors, such as sterility & elimination of pyrogens are important.

This technology, over the last few years, has achieved prominence and is now preferred by Pharmaceutical companies focused on zero water discharge for environmental protection.

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Tech Specification

Injectable / Sterile Unit Water For Injection (wfi) Plant

All MACHINFABRIK Thermo Compression distillation units 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 output WFI quality complies with requirements of IP, BP, US FDA and EU GMP norms.

WFI is generated using the principle of distillation.

The evaporator column comprises of three zones – the Heating Chambers, the Condenser and the Top Dome.

Feed water is filled in the bottom heating chamber and in the tubes of the centrally located Condenser. Plant steam heats the feed water in the bottom chamber to generate vapor.

The generated vapor passes through multi-directional bottles where the pyrogens are removed to produce pure steam at low temperature and pressure. This pure steam is then drawn by the compressor where it is pressurized to increase its temperature and pressure. The high temperature and pressure pure steam is discharged by the compressor on the shell side of the condenser. The pure steam passes latent heat to the feed water thereby evaporating it and in tube condenser.

The pure steam condensate, WFI is collected in a WFI buffer Tank from where it is pumped via a Pre-Heater to the WFI outlet point.

The operation of the system is fully automatic and with data logging facility for best and consistent results.

The Evaporator Columns, Compressor, WFI Buffer Tank, Feed Water Preheaters, 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 square pipes using argon welding and is polished to a dull finish.

The Evaporator Column and Heat Exchangers 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 Condenser in the Evaporator column is a Shell and Tube heat exchanger. All pressure parts are hydro-tested and inspected. The evaporator column is fitted with a sanitary sight glass to monitor the water level in the system.

All columns are insulated with 25mm Rock Wool insulation that is encased in a SS304 cover with dull finish.
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 Feed Water Cooler is fitted with a Degassing attachment to remove the non-condensable gases from the generated WFI. The Degassing nozzle is fitted with a 0.2μ bacteria retentive vent filter to draw air when the system cools down after it is shut.

The boiler steam to the machine is provided with an automatic control valve. The line is also fitted with an over pressure safety valve and a pressure gauge.

The Feed Water the line is provided with two proportionate control valves for regulating the flow via Pre-Heater 1 and Pre-Heater 2. In addition a flow Meter and conductivity sensor are provided.

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 Vapor Compression Distillation System 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 WFI outlet of the system is fitting with RTD sensor & conductivity sensor.
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, flow transmitter with VFD for feed water, utility isolation valves & gauges, boiler steam PRV, drain condenser, self-sterilization program, UPS.