DITEC - Multi effect distiller
Thanks to the experience TECNinox has gained in the handling of pure fluids, it is undoubtedly the ideal partner for complete water and steam purification systems, from design to execution, through to storage and distribution to the various user. TECNinox has been active in this market sector for several years now and has built up the experience required to develop and construct water for injection generators able to meet the widest Customer requirements for production potential and for checking and monitoring the final steam quality . Together with the Customer user, TECNinox can assess and develop the best technical solution to guarantee continuity of operation and performance, user-friendliness equipment and cost effective operating costs.
Principle of operation
Distillation process consists of water steaming, followed by steam condensate, to eliminate the most volatile or non-volatile impurities at water boiling temperature. Multi-effect distillation process includes several effects in which evaporation and condensate usually occur at the same time. Feed water evaporates in columns consisting of tube condensers and decontamination chambers (so-called “effects”) joined by a flange connection and having different pressure and decreasing temperature. The first effect is fed by an external heat source; in the subsequent effects this energy is totally reused being energetically self-sufficient. The number of effects is usually included between three and seven. An increasing number of effects involves more investment costs reducing operative cost at the same time, thanks to higher percentage of recovered energy compared to energy fed in the first effect.
Fine chemical, Biotechnology and Pharmaceutical industries need to produce water for injection. Our range of multi-effect distillers (DITEC) has been designed for the production of Water for injection (WFI) according to cGMP good manufacturing standards in compliance with the European Pharmacopeia and USP guidelines.
TECNinox water distillers belong to the last generation of multi-effect distillers. The system stability ensures a reliable and automatic production of pyrogen-free and high-quality sterile “Water for Injection” (USP, EP, JP). Our computer-aided design with 3D modelling, are constantly updated according to the state of the art heat transfer technology. Distillation columns comply to ASME International rules (U stamp) and PED rules (for Europe), including other design procedures requested by specific countries.
Service and support
• From the purified water generator to storage and distribution, TECNinox gives its Customers the advantage of working with a single company that is experienced in the handling of pure fluids
• The drawing up and filling in of validation records allows us to offer the Customer complete packages and comprehensive installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) programs.
• After installation, TECNinox service engineers will provide training courses for the use of the system and provides technical and maintenance support to meet every specific requirement.
The multi-effect distiller, like all pressure recipients, will be supplied with the conformity certificate to the 97/23/EC PED/ASME directive and to the harmonized 2006/42/EC machine directive. The relative pressure, temperature features and fluid groups are reported. An user’s manual will be provided with the steam generator reporting all maintenance, pre and post installation safety devices, after-sale service details. Our personnel will deliver the user’s manual during training. Validation package documents will be provided on request in accordance with the pharmaceutical application standard and consist of:
• FAT protocol
• IQ/OQ protocol