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.

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These waters for pharmaceutical use exist in two different bulk forms. Purified Bulk Water (EPV) and Water for Injections Bulk (EPPIV) are described in detail in all pharmacopoeias, including the American, European, Japanese and Chinese Pharmacopoeias. Pure condensed vapor is considered EPPIV.For the production of liquid, solid, injectable or biological drugs, the pharmaceutical industry uses these two qualities of water: EPV and EPPIV. Different technologies for the purification of drinking water (good for human consumption) are available to produce these two qualities of water for pharmaceutical use. WTT takes a lot of care in pre-processing to be able to use the best production technology. The performances are linked to the quality of drinking water supplied or made drinkable and to the quality of the water for pharmaceutical use requested, to the investment cost, to the operating cost, to its reliability, to its robustness, its sustainability and the elimination or reduction of risks associated with the chosen technology.WTT as a specialist meets all these criteria and with its team of experts, carries out the engineering, design, construction and installation of production and distribution facilities for water for pharmaceutical use. Of course WTT also performs commissioning, qualifications (design qualification, installation qualification and operational qualification) and maintenance. WTT installations for the production and distribution of water for pharmaceutical use (purified water in bulk (EPV), water for bulk preparations (EPPIV), pure steam (VP) are robust and provide the continuous performance required. water for pharmaceutical use and pure steam comply with current pharmacopoeias and good manufacturing practices (GMP).
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) .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.