• Жидкие лекарственные формы
    • Dara
      Комплексные линии розлива и укупорки для флаконов, картриджей и шприцев
    • Ellab
      Решения для валидации и мониторинга процессов
    • Extract Technology
      Герметичные и асептические системы для фармацевтических, медицинских, биотехнологических и химических рынков
    • Fedegari Autoclavi SPA
      Автоклавы, изоляторы, сухожаровые шкафы и депирогенизаторы
    • GEA Lyophil
      Лиофильные сушки и системы выгрузки/загрузки флаконов на полки
    • GEA Niro Soavi
      Сепараторы и гомогенизаторы высокогого давления
    • Optrel
      Автоматические инспекционные машины для проверки заполненных фармацевтических контейнеров для жидких и лиофилизированных продуктов
  • Чистые среды
    • Tecninox
      Оборудование для производства инъекционных и инфузионных растворов, ферментации, сепарации плазмы, водоподготовка
  • Твердые лекарственные формы
    • Frewitt
      Молотковые, конические и осцилляционные мельницы
    • GEA Aeromatic-Fielder™
      Высокоскоростные миксеры и процессоры в псевдоожиженном слое
    • GEA Buck® & Buck Systems™
      Герметичные соединительные системы для перегрузки продуктов
    • GEA Collette™
      Миксеры-грануляторы с верхним приводом, однокамерные процессоры, непрерывные системы грануляции
    • GEA Courtoy™
      Высокоскоростные роторные таблетпрессы
    • kg-pharma
      Tablet presses
    • NOTTER
      Таблеточный пресс-инструмент премиум класса
    • Pharma Technology S.A.
      Обеспыливатели для таблеток и капсул, таблеттестеры
    • ProCepT
      Компания ProCepT является производителем технологического оборудования и поставщиком услуг для процессов сушки, агломерации, покрытия и смешивания
    • Xedev
      Xedev является поставщиком услуг в области инжиниринга частиц и разработки процессов

DITEC - Multi effect distiller

Complete solutions

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.

DITEC application

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.

Engineering

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.

Documentation

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