Water produced for the pharmaceutical or cosmetic industry must comply with stringent regulations.
Regulatory texts:
Recommendations:
Many texts have been published by organizations and associations: Pharmeuropa, ASPEC, SFSTP, A3P, EHEDG, FDA, 3A, ISPE, ICH, PDA, etc.
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:
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:
Elmatec offers units integrating membrane technologies (MF/UF/NF/RO) and electrodialysis for demineralization and purification/concentration of process solutions.
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Specialists in the production of purified water and membrane-based separation technologies for industry.
