Product Details

WFI STILL

All pharmaceutical production processes require a stable & consistent supply of quality-controlled water for applications ranging from non-critical processes to product formulation. The most important equipment in any pharmaceutical plant manufacturing injectable solutions is the WFI Still. Our WFI Still produces distillate that meets the current U.S and European pharmacopeia for Water for Injection guidelines systems equipped with a range of features to ensure that your installation and qualification is quick & trouble-tree and that your WFI production remains efficient and reliable.
Machinfabrik WFI Still is designed with efficiency in mind. Since the system recovers the latent heat of vaporization occurring within its own process to heat feed water and uses the feed water as the primary source of cooling, our system is an energy and money-saving ingenuity.

Categories
Tech Specification

Injectable / Sterile Unit Water For Injection (wfi) 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 output WFI quality complies with requirements of IP, BP, US FDA and EU GMP norms.

The WFI Still works on the distillation principle.

The external boiler steam heats the first column. The vapor generated from heating the feed water rises up the column where it is subjected to the entrainment separation system. Multidirectional baffles deliver the first punch. The steam generated is made to pass a torturous path through multidirectional baffles. Here the pyrogenic particles and droplets are separated out and are guided to the bottom of the column.

A centrifugal type cyclone separator in the upper column delivers the second punch. Here the vapor is guided through a narrow circular channel where it begins to rotate. The vapor flow subjects the pyrogenic impurities and droplets to a high centrifugal force thereby dislodging them from the vapor steam.

The steam generated in the first column is used as a heating medium for the second column. The steam generated in the second column is used as a heating medium for the third column. In this manner the heat in the generated Pure Steam heats subsequent columns. Thus the columns are connected in series into a multiple effect system and external energy is required only at the first column.

The generated steam vapor of the last column and the almost condensed Pure Steam distillate (2^nd column onward) is led to the overhead cooling heat exchanger, where it is cooled by the cooling water & incoming feed water to generate WFI. The incoming feed water is thus pre-heated resulting in excellent heat recovery and system efficiency.

The pre-heated feed water enters the first column and after filling to the required level overflows to the second column and so on. A small quantity of feed water overflows from the last column to ensure that the system does not starve for WFI.

The operation of the system is automatic with automatic dumping at the WFI outlet for dumping distillate having high conductivity and / or low temperature.

The Distillation Columns, Feed Water Cooler, Cooling Water Cooler, 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 Distillation 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 Heat Exchanger in the first column is a double tube sheet heat exchanger. The heat exchangers in the subsequent columns are of conventional shell and tube design.

All Distillation Column and Heat Exchangers are hydro-tested and inspected. The first and the last 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, over pressure safety valve, pressure gauge and RTD Pt100 temperature sensor for low steam 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 and Flow Meter. The return line is fitted with a NRV and temperature sensor.
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 WFI 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 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.