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Water For Injection System (WFI)

Water For Injection System (WFI) can be created through distillation and through further purification by Reversed Osmosis. The more common method is through distillation, which is an intrinsically safe method. If a distiller would fail or produce insufficient heat, there is no evaporation and no WFI generation. Whilst the use of RO and polishers can generate WFI, it is a cold process and not intrinsically safe as seal ruptures or membrane failures are not easily detectable without the use of additional equipment such as inline micro or endotoxin monitors.

Water for Injection Eur.Ph Specfication

Water for Injection USP Specification

Honeyman can offer both water for injection system solutions, however, our typical designs would always consider distillers as the preferred method.

Single Effect Distillation Units

Our single effect distillation units can produce both pure steam and WFI, depending on operational requirements and is a perfect solution for applications with limited demand or budget constraints. The Single Effect Stills are available with an electrical heat source or steam as the primary heat source.

In the single effect still the heated deaerated feed water is used to create saturated steam. Droplet entrainment is controlled through the use of centrifugal and gravity separation methods.

All parts in contact with process fluid and steam in the single effect stills are constructed from AISI 316L stainless steel and are designed in accordance with P.E.D. pressure regulations. All pipes are orbitally welded, where possible and fully traceable. 


Multiple Effect Distillation Units

Our Multiple Effect Stills are designed and manufactured according to cGMP to produce Water for Injection (WFI). Each unit contains a number of boiling columns (or effects) with the first column producing pure steam, which is condensed and re-distilled in the following columns decreasing operational costs.

Double Tube Sheet (DTS) exchangers provide swift and effective heating for evaporation and cooling for condensation processes. Condensation is achieved by means of the thin-falling film technology.

The process is repeated in each column: the higher the quantity of columns, the lower overall the consumption of the equipment. The quantity of columns therefore does not influence the quality nor the output of the equipment.

A special labyrinth-separator installed at the top of each column separates the steam generated by the evaporation process from entrained substance in the steam itself. The result is a pure, “dry”, pyrogen-free steam, condensed in compendial Water for Injection.

The first column of the Still may be used to produce alternatively or even at same time, also Clean Steam. Pressure vessels are designed according to PED regulation and the equipment features:

  • Double tube sheet heat exchangers
  • Certified AISI 316L stainless steel mirror-polished and passivated product contact surfaces
  • AISI 304 frame, jackets and control board
  • PTFE gaskets
  • Pneumatic valves with Teflon membranes and AISI 316 L SS polished body
  • ASTM C-795 – compliant insulation.
  • Capacities range: from 50 to 15,000 lph with three to eight columns.

      

Vapour Compression Distiller

Our Vapour Compressions Distillers can produce both hot or cold distillate with huge savings of energy costs and with no need of cooling water. Vapour compression distillers operate with electrical heating and/or plant steam. Capacities range from 20 –20,000 lph.

Furthermore, customized models with pre-treatment systems integrated on the same skid (STMC AEL/AST, electrical/steam heating with automatic water softeners; REL/RST, electrical/steam heating with water pre-treatment + reverse osmosis system) allow STMC distillers to virtually work with any water quality available on site.

The recognised benefits of the Vapor Compression Distillation Technology are:

  • Low energy consumption
  • No need for cooling water to condensate the pure steam
  • No need for high quality feedwater (in some cases even softened water can feed the VC still)
  • Produces high quality WFI due to the strong degassing process
  • No need for pressurised feedwater
  • WFI outflow at high pressure (1–1.5 bar) without any additional pump
  • Extreme safe process, with no risk of any cross contamination through plant steam or inlet water
  • Highest flexibility in terms of capacities and WFI temperatures
  • Reduced Maintenance

The design, construction and documentation of Vapour Compression Stills strictly comply with GMP and FDA regulations, ensuring an easy certification by the relevant authorities. In detail:

  • All VC stills are made from certified AISI 316L stainless steel
  • All internal parts in contact with the infeed water, the Pure Steam and the Distillate, are mirror-polished
  • All hydraulic connections are sanitary tri-clamp or flange connection
  • All gaskets are made in PTFE
  • All weldings are T.I.G
  • Vapor is compressed by a special blower

A full automation (Siemens®, Rockwell®, SCADA system) ensures easy operation and total monitoring of critical parameters, by means of certified in-line instruments and of a careful alarm policy. Access policy and records can be managed according to 21 CFR PART 11.

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