Water for pharmaceutical processes is defined by the European (EP), American (USP) or Japanese (JP) Pharmacopoeias.
Several monographs of water for pharmaceutical use exist:
Note that the monograph « Water, highly purified water (HPA)” was suppressed from the European Pharmacopoeia as of April 1, 2019 by decision of the European Pharmacopoeia Commission (160th Session, March 2018).
The main quality criteria for pharmaceutical water are defined by:
Elmatec designs and installs water production and distribution units for the pharmaceutical industry in compliance with pharmacopoeias and good manufacturing practices (GMP). The main reference texts are:
From a drinking water source, Elmatec defines a treatment system to obtain the desired water quality.
The production of pharmaceutical water for both bulk purified water (BPW), and bulk water for injection (BWFI) consists of a reverse osmosis unit (single or double-pass / bi-osmosis) that can be associated with electrodeionization (EDI).
An ultrafiltration stage at 0.02 µm is used to obtain apyrogenic water (retention of endotoxins) in the case of BWFI or purified water for dialysis.
Elmatec, as a distributor of SUEZ Water Technologies equipment (cartridge filtration, hollow fiber ultrafiltration, reverse osmosis, pharmaceutical electrodeionization, etc.), has access to all products and technologies required to build a high-performance solution.
The production unit is equipped with instrumentation to control flow, pressure, conductivity and temperature.
Storage allows peak demand to be smoothed out and ensures permanent circulation in the distribution loop.
To maintain the good bacteriological quality of the water produced, the storage tank is injected with ozone. Elmatec uses Ozonia Membrel type electrolytic ozone generators by Suez.
A UV generator installed at the beginning of the loop destroys the ozone before use. The distribution loop is periodically disinfected by stopping the UV generator and circulating ozonated water.
The following instruments are used to permanently monitor the quality of the water distributed:
An essential step in the validation of a pharmaceutical water station is defined in a Validation Master Plan (VMP) and includes:
This GMP guideline makes it possible to prove that the equipment is installed correctly, functions properly, and produces the expected results.
The design of pharmaceutical water installations is defined in the following reference documents:
Elmatec provides the equipment certificates to ensure compliance with the design rules established for a pharmaceutical water unit:
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