Pharmaceutical & Biotechnology

Water for pharmaceutical use (EUP) is the most widely used ingredient in the manufacture of drugs, the main component in cleaning and disinfecting equipment; therefore, pharmaceutical facilities for the production, storage, distribution of water for pharmaceutical use and pure steam are essential elements. WTT, using its know-how, is committed to providing facilities in accordance with the customer’s request and guarantees to take great care to avoid any chemical and especially bacterial contamination.
Purified Water & High Purified water

Purified bulk water can be produced by any suitable process from water meeting the regulations for water intended for human consumption. It does not contain additives. This bulk purified water is used for the manufacture of active ingredients, in dry forms, as an excipient for non-sterile, non-pyrogenic liquid products and as a solution for cleaning and rinsing equipment.

WTT, depending on the needs of these customers, uses the most robust and efficient technologies to produce bulk purified water, for example: double reverse osmosis (RO / RO), or reverse osmosis followed by electodeionization ( RO / EDI), or double reverse osmosis followed by electodeionization (RO / RO/EDI )or a pure steam thermo-compressor still in the event that drinking water is highly variable and difficult to treat.

Water for injection
Bulk water for injections differs from bulk purified water in that it must be prepared by distillation or equivalent process. This bulk water for injections is used for parenteral administration.WTT produces EPPIV from a multi-effect still or distiller by thermocompression of pure steam or by a RO / RO / UF or RO / EDI / UF or RO/RO/EDI/UF membrane assembly. WTT for long-term performance reasons recommends installing stills that are 100 percent satisfactory.
Pure Steam System

Purified bulk water can be produced by any suitable process from water meeting the regulations for water intended for human consumption. It does not contain additives. This bulk purified water is used for the manufacture of active ingredients, in dry forms, as an excipient for non-sterile, non-pyrogenic liquid products and as a solution for cleaning and rinsing equipment.

WTT, depending on the needs of these customers, uses the most robust and efficient technologies to produce bulk purified water, for example: double reverse osmosis (RO / RO), or reverse osmosis followed by electodeionization ( RO / EDI), or double reverse osmosis followed by electodeionization (RO / RO/EDI )or a pure steam thermo-compressor still in the event that drinking water is highly variable and difficult to treat.

Distribution system
WTT is putting in place the means to make water for pharmaceutical use available at points of use (POU), while maintaining its quality. WTT includes tanks, pumps, heat exchangers, piping, valves and accessories, radiation generators , UV, ozone generators (by electrolysis). WTT also installs the management and monitoring elements (sensors and regulators). WTT connects the fluids (drinking water, ozone, nitrogen, compressed air, steam, glycol water, electricity) necessary for the proper functioning of the installation.WTT takes care that all the elements in contact with water for pharmaceutical use are of high quality and homogeneous roughness: tanks, pipes, etc. Any lack of homogeneity will be justified by WTT. The choice of surface quality is linked to the technologies implemented in terms of disinfection and sterilization. WTT sizes the distribution loop so that the circulation regime of water for pharmaceutical use is turbulent. In this case, the Reynolds number must always be greater than 4000. Indeed, the laminar regime (speed equal to zero at the walls) increases the risks of adhesion of microorganisms in the event of contamination (biofilm). WTT makes the loop without a retention zone, without a dead arm, with the instrumentation and accessories mounted on a clamp (with an equivalent surface finish).

Pretreatment

Regardless of the level of quality required, the raw water source is usually that of the drinking water network or a local resource such as borehole water. This water, although it must meet strict drinkability criteria, is not suitable as such for pharmaceutical applications. Water intended for human consumption contains elements that are undesirable, either for the production process or to achieve the necessary level of quality.

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WTT, thanks to its knowledge of the field and its know-how, does what is necessary to carry out a pre-treatment allowing to have water that meets the needs of the chosen producer, and olso in order to keep reverse osmosis membranes efficiency and long lasting. According to the origin, quality and use of feed water, solutions might consist in providing suitable filters, softeners, dosing systems, heat ex changers…etc

Validation

As a general rule, the matrix of the qualification master plan is established and finalized in parallel with the phases of the call for tenders, the offer and the order (by the customers) .WTT carries out the Conceptual Qualification (DQ) which defines and gives documented proof that the required quality is taken into account. The Conceptual Phase (DQ) forms the basis for future activities that will be carried out during Installation Qualification (IQ) and Operational (OQ) .

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WTT performs Installation Qualification (IQ) which defines and provides documented demonstration that equipment and systems are installed in accordance with approved plans, technical specifications and legal safety guidelines. Carried out by WTT after the commissioning of the entire installation, the Operational Qualification (OQ) defines and provides documented proof that the equipment and systems are functioning as intended. After the Operational Qualification (OQ), the Performance Qualification (QP) which is the customer’s responsibility, checks the capacity of the equipment and the system.

Sanitization

Water Treatment Technologies use one of the most effective and safeway to disinfect Ultra-Pure Water loops in industrial and pharmaceutical applications: the electrolytic ozone generators.
The residual ozone is destroyed by a sanitary UV system.
The quantity of ozone is controlled at the purified water tank outlet and the UV system.
WTT can also provide a chemical or a heat sanitization which requires membranes and EDI modules suitable for hot water circulation.