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Water produced for the pharmaceutical or cosmetic industry must comply with stringent regulations.

Regulatory texts:

  • European Directives on the quality of water intended for human consumption and national implementation decrees
  • Good Manufacturing Practices (GMP)
  • Current Good Manufacturing Practice (cGMP)
  • Pharmacopoeias (European – American – Japanese)
  • EMEA, PICS/S, Annex 15 (qualification and validation)

 

Recommendations:

Many texts have been published by organizations and associations: Pharmeuropa, ASPEC, SFSTP, A3P, EHEDG, FDA, 3A, ISPE, ICH, PDA, etc.

BPW, WFI and distribution loop

Pharmacopoeias define precise qualities of water and how they are obtained. The monographs selected are those for bulk purified water (BPW) and bulk water for injection (BWFI).

The technological choices of production and distribution must be made according to:

  • Feedwater quality
  • Qualitative requirements
  • Quantitative requirements
  • Investment cost
  • Cost of analytical controls
  • Maintenance cost
  • Cost of investigating non-compliance

Elmatec designs and installs water production and distribution units for the pharmaceutical and cosmetics industries in compliance with pharmacopoeias and good manufacturing practices (GMP).

Elmatec incorporates the regulatory approach of IQ/OQ qualification of installations, with a view to Performance Qualification (PQ) borne by the manufacturer.

As a distributor of Suez products, Elmatec is able to offer complete solutions including:

Process Applications

Elmatec offers units integrating membrane technologies (MF/UF/NF/RO) and electrodialysis for demineralization and purification/concentration of process solutions.

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