PW & WFI Generation

Purified Water & Water For Injection:

Pure technology, pure water…………………….

Water is the most widely used product in the pharmaceutical industry.

In order to satisfy the demands of our clients who are frustrated with using suppliers who were unable to offer flexibility in product development, manufacture and project management we have developed our own range of high quality water generation systems. All works are carried out by our own personnel enabling us to better manage complete turnkey projects and provide the highest level of quality.

Our water treatment plant consists mainly of the following treatment steps:

  1. Pretreatment system
  2. Purified Water (PW) Generation
  3. Water for Injection (WFI) Generation
  4. PW & WFI Storage & Distribution

 

Plant Capacity:

Our standard plants can cover a range of production from 200 liters per hour to 30.000 liters per hour. Larger sizes are available on request.

 

Pretreatment system

The feed water characteristics and pretreatment are fundamental to the use of the membranes and the EDI modules. Pretreatment is necessary for:

  • removing particles which could damage the membranes
  • reducing the possibility of scale precipitation
  • elimination of free chlorine

we are able to furnish the pre-treatment suited to every requirement. For sizing of plant it is necessary to know the complete raw water analysis.

We can supply:

  • Potabilization plant
  • oxidation processes for elimination of heavy metals
  • sand and multimedia filters
  • activated carbon filters simple or steam sterilizable
  • zeolyte filters
  • organic scavengers
  • softeners
  • chemical dosing system
  • microfiltration systems
  • UV lamp

A particular care is paid in designing the pretreatment systems, so to even grant the lowest risk of bacteriological uncontrolled growth.

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Pretreatment system-softener. Hot water sanitization type

 

Purified Water Generation Plant:

Our pure water generation plants are the result of many years of experience and constant technical development. They represent the simplest, safest and most reliable water purification method for:

• Production of ultra pure water for Pharmaceutical, cosmetic and food industries.

• Production of deionized water for industrial use when high bacteriological and chemical quality is required.

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Individual Process Steps PW Generation Unit

  • Pre-filter
  • Raw water station
  • Multimedia filter
  • Dosing of Bisulfite
  • Softening
    • Hardness measurement
  • ROCEDIS
    • Reverse Osmosis
    • Membrane Degasification
    • Electro Deionisation (EDI)
    • Automatic Hot Water Sanitisation ROCEDIS TS
    • Intermittent Control
  • Quality Monitoring
  • Plant design and Construction

 

Water for Injection (WFI) Generation / Multiple-Effect Water Stills:

The CS multiple effect stills consist of a series of pressure vessels in the form of columns, called distillation columns or effects, that are interconnected, communicating vessels. Each column is divided into two parts:

  • A double tube sheet (DTS) heat exchanger that acts as an evaporator,
  • And an upper chamber used to separate pyrogens preventing the drops carrying impurities from reaching the end of the column.

The group is supplied as a compact unit on a skid with all components readily accessible. 

wfi

Accessories & Options: 

  • Inlet water conductivity monitoring
  • Point to obtain pure steam from the first column
  • Condenser for higher WFI
  • Hot stand-by mode
  • Sanitization/Sterilization of the different columns and WFI condensers Protection panels

Applications 
Pharmaceutical water, defined in the European Ph and the USP, is used for preparing parenterally administered medicines, when the water is used as a vehicle (bulk water for injection) and to dissolve or dilute substances or preparations for parenteral administration before use (sterilized water for injection). According to the Ph Eur 4, water for injection can only be produced by distillation, using drinking or purified water as a source.

Description 
The design of the unit offers excellent performance for production of water for injection. Simplicity and efficiency: A group of distillation columns in series designed to evaporate the purified water and condense pure steam. Their design allows the steam water drops, containing impurities, particles and pyrogens to be separated by the effect of gravity. This design has proven to reduce the level of endotoxins by 3 to 4 log.

Fully sanitary design: The exchanger bodies and the separation chambers are electropolished after mechanical polishing, to provide greater resistance to corrosion produced by “rouging”. The exchanger pipes, AISI 316 L stainless steel, seamless pipes, in accordance with ASTM 270, are bored (expanded) at both ends, in the double plate, so that they are free from cracks and their useful operating life is extended. The pipes with active surfaces have been already mechanically polished when they are purchased from the supplier, with a surface roughness of Ra < 0.6 ?m. The inline, detachable connections are TC sanitary type (Tri-Clamp), with Gylon® Bio-Pro gaskets (with FDA certification). All welding is carried out in inert gas atmospheres (argon), with automatic orbital welding whenever possible. Low maintenance: The inside of the pipes is filled with non evaporated water from the previous column. The pipes are always immersed in water, preventing liming. Furthermore, as they are relatively short, they do not dilate or vibrate, minimising leaks. The column gasket is very easy to change. The skid is made out of AISI 304 stainless steel. Safety and easy operation: Operation is fully automated by means of sensors. The unit has all the required safety and protection equipment, with warning signals and alarms. A PLC performs the control and management of the equipment. The equipment can be easily supervised and controlled by means of a touch screen in the control panel.