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      Комплексные линии розлива и укупорки для флаконов, картриджей и шприцев
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      Решения для валидации и мониторинга процессов
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      Герметичные и асептические системы для фармацевтических, медицинских, биотехнологических и химических рынков
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    • GEA Niro Soavi
      Сепараторы и гомогенизаторы высокогого давления
    • Optrel
      Автоматические инспекционные машины для проверки заполненных фармацевтических контейнеров для жидких и лиофилизированных продуктов
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      Герметичные соединительные системы для перегрузки продуктов
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      Миксеры-грануляторы с верхним приводом, однокамерные процессоры, непрерывные системы грануляции
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    • NOTTER
      Таблеточный пресс-инструмент премиум класса
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      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

GVP - Генератор чистого пара

Генератор чистого пара

Паровые генераторы представляют собой устройства, способные отделить примеси (частицы, пирогены и т.д.), содержащиеся в каплях и, следовательно, постоянно производить чистый пар высокого качества.

Complete solutions

Thanks to the experience TECNinox has gained in the handling of pure fluids, it is undoubtedly the ideal partner for complete 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 pure steam 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-friendly equipment and cost effective operating costs.

Principle of operation

The feed-water, pressurized by the feeding pump, circulates through a pre-heater (optional) to increase the feed water temperature, then the water goes into the evaporator column and to the main exchanger — pipes side. The high temperature of industrial steam (shell side) heat the water to the evaporation temperature, creating a thermo siphon circulation effect between the evaporator and the separator column. The steam develops in the column, its low velocity and the height of the column eliminate any possible impure water droplets entrainment. The pure steam pressure is maintained at the value set by the algorithm (PID) with direct action on the industrial steam modulating valve, evaporator shell side.

GVP application

Pharmaceutical, Biotechnology, fine Chemical & Cosmetics Industries, Research Institutes and Universities more and more often demand processes with final sterilization for reactors, preparation vessels, autoclaves, filters, piping, etc. The saturated and pyrogens free pure steam is produced in accordance with last USP and European Pharmacopeia guidelines. TECNinox’s pure steam generators GVP series are designed and built in accordance with the good manufacturing practice cGMP and with FDA standard approved material suitable for pharmaceutical products.

Design and construction features

The steam generator is manufactured in AISI 316L stainless steel, PTFE and elastomer gasket with FDA certificate. The evaporator and the separator column are insulated with mineral wool and cover with AISI 304 stainless steel sheet. All the components are assembled on a painted carbon steel. All fittings, valves, and components are sanitary type, suitable for a non-stop use of pure steam generator. The control system is inside an electric cabinet. The industrial PLC and the operator panel placed on the front door, control various operating phases, regulating the pure steam pressure outlet, the water level inside the column, the feeding pump, and the visualization of process parameters.

 

Available options

CONDUCTIVITY
Conductivity of feeding water and condensate pure steam can be constantly monitored and recorded. The monitoring system includes an automatic control of set value with an alarm to stop the generator.
ELECTROPOLISHING
Internal surface of under pressure container can be electropolished with a Ra=0.3 micron finishing.
FRAME/CONTROL BOARD
It is available on request to manufacture the control cabinet and the framework in AISI 304 stainless steel.
CONDENSING UNIT
The steam generator can be equipped with condensing unit for production of very high quality distilled water for injection. (WFI)
SAMPLING
The sampling unit is composed by a cooling exchanger in order to condense steam and take a sample.

Documentation

The steam generator will be delivered with the conformity certificate to the 97/23/CE PED/ASME directive and 98/37/CE machine directive. The generator will have an external plate reporting the pressure, temperature features and fluid group. An user’s manual will be provided with the steam generator, it reports all the indications regarding unit maintenance, safety, pre and post installation, troubleshooting and after sales service. The user’s manual will be delivered by our personnel during the commissioning / training. The validation package documents will be provided on request, in accordance with the pharmaceutical application standard. It is including by:
• FAT protocol
• IQ / OQ protocol