Pharmaceutical Water Systems

Purified Water Generation systems

Each plant for the production of purified water is custom made, whether its capacity is 100 l/h or over 25 m3 /h. Every plant is designed with the customer and all the design parameters in minute details and with the same passion and dedication towards building an effective, safe and reliable system. After all each customer has a different system requirement: An SME engaging in contact manufacture has need which differs from an international conglomerate. Thus no plant is entirely like any other. ALL KOMAL PW basic systems meet EP, USP and guidelines and ensure the production process, product quality and profitability. The GMP-compliant confirms to FDA and ISPE requirements.

All KOMAL PW systems are pre-tested, validated, compact and ready-to-use. The compact, package unit design on a stainless steel skid, are specifically adapted to the high TDS water and offers all purification technologies, which, such as :

  • Automatic Sand and Activated carbon filters
  • Duplex softening units, serially connected and quality-controlled with optional HOTwater sanitization.
  • Demineralization systems
  • Ultrafiltration units with 6000 Daltons cutoff
  • HOT water sanitisable electrodeionisation units.
  • UV Disinfectant
  • Single or two-pass reverse osmosis
  • Membrane degassing for CO2 reduction
  • ORBITAL welded SS316L tubes
  • State-of –the-art PLC technology.
  • 21 CFR part 11 compliant control panels.
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Purified Water and WFI storage tanks

After the purification of PW or HPW, engineering of the customer-specific storage and distribution system takes place, so product water can be delivered to each point of use in the sterile distribution system without recontamination. Here to we consider the customer's specific conditions and produce an individually engineered design. Following are the features of the KOMAL PW storage tank:

  • 316L SS storage tank for PW and HPW
  • Internally electropolised.
  • Externally mirror / matt finish
  • Jacketed hydrophobic 0.2 micron Vent Filter
  • Level transmitters
  • Compound Pressure gauge
  • Pressure release valve
  • Spray ball
  • STEAMtrap assembly
  • Inlet STEAM control valve
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Purified Water and WFI Distribution Systems

Once the PW is stored in a tank, it now needs to be distributed to each and every point of use in the factory without recontamination.

The entire distribution system is be made of 316L stainless steel tubes, the surface quality from Ra <0.8µm to Ra <0.4µm. The tubes are orbital welded together.

The designing of the PW distribution system requires detailed engineering towards achieving a sterile environment. Some of the features of KOMAL PW distribution system are:

  • Frequency controlled and sanitary distribution pump
  • Optional dual pump station
  • High efficiency UV disinfection / ozone reduction
  • Temperature controllers
  • Temperature compensated conductivity measurement
  • Flow management through a vortex flow meter.
  • Ozonation
  • On-line TOC measurement
  • Optional thermal sanitization at > 800C
  • Sterile sampling valve
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