Products

Compliance with cGMP requirements
The treated water meets American regulations (USP) and European Community directives. This is because ROTEC is constructed following the “modular” criteria, with the insertion of completed pre-wired sections to form the ideal tailor-made unit.

• Pre-treatment module
• Sanitation module
• U.V. system module
• Cleaning module
• E.D.I. module
• Electrode ionization

In the case of final polishing after the reverse osmosis stage, the above-mentioned capacity should be considered 10% higher.

Automation
We are able to supply the plant with any type of operating control you require starting from local instrumentation with manual controls, up to DCS or SCADA fully integrated systems. Temperature, conductivity, flow, TOC are considered our windows to the process, by utilizing instrumentation in conjunction with process control we can keep the difference between measured and desired values of variables. The control system is designed according to GAMP and 21 CFR part 11 regulations.

                                                                           Models

Maximum size

 Selected configuration may impact on the final dimensions and weight of the unit.

Components check
Osmosis is the natural principle by which two solutions of different concentrations are separated by a semi-permeable membrane. Here the more dilute solution passes under osmotic pressure into the more concentrated solution until equilibrium between the two pressures is reached and fluid flow stops completely. The main use of osmosis is to produce water quality according to pharmaceutical standards.  

The parameters checked and controlled are: 

• Feed water conductivity
• Permeate water conductivity
• Rejection capacity of the membrane(s)
• Temperature of the water produced
• Head and rotation of the booster feed pump
• Flow regulators and indicators 

Support

• 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, our service engineers will provide training courses for the use of the system and provide technical and maintenance support to meet every specific requirement.

GVP application
Pharmaceutical, Biotechnology, fine Chemical & Cosmetics Industries, Research Institutes, and Universities increasingly demand processes with final sterilization for reactors, preparation vessels, autoclaves, filters, piping, etc. The saturated and pyrogen free pure steam is produced in accordance with last USP and European Pharmacopeia guidelines. Our 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 covered with AISI 304 stainless steel sheeting. All the components are assembled on a painted carbon steel. All fittings, valves, and components are of the 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.

Pure Steam Production Capacity kg/h @ 3 barg

                                                                                 The above data has a tolerance of +5%

Think. Design.

• AISI 316L Stainless Steel materials in contact with the product
• Insulation
• AISI 304 Stainless Steel cover (satin/shiny)
• Sanitary main components and fittings
• PLC control system

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
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 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. A 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:

• FAT protocol
• IQ / OQ protocol

Storage and Distribution system
We have vast experience in designing, supplying, installing, and validating purified water distribution systems. Storage tanks and distribution pipework systems are potential sources of contamination, particularly from bacteria. Good design practice and proper maintenance regimens are needed to minimize problems. Various methods can be used to avoid quality degradation during storage and distribution of the highly water system.

Our high purity systems are designed in accordance with cGMP guidelines and comply with international codes and regulations governing medicinal product manufacture referred to in various regional Pharmacopeia, for example USP, EP, and JP. These regulations specify standard of purity for several waters including Purified Water, highly Purified Water and Water for Injection.

Key criteria for Purified Water (PW) – (HPW) & Water for Injection (WFI) loops

• No stagnant conditions and areas of low flow rate.
• Temperature control.
• Proper slope of the pipeline to ensure drain ability.
• Stainless steel surface finish with appropriate roughness to avoid nutrient and biofilm accumulation.
• No dead legs area.
• Periodic sanitization or sterilization of the storage tank and loop.
• Storage tank protected with 0.2-micron hydrophobic vent filter.
• Sufficient instrumentation and monitoring equipment.

We are able to supply the plant with any type of operating control you require starting from local instrumentation with manual control, up to a DCS or SCADA fully integrated system.

Temperature, conductivity, flow, TOC are considered our windows to the process, by utilizing instrumentation in conjunction with process control we can keep the difference between measured and desired values of variables. The control system is designed according to the GAMP and if required 21 CFR part 11 compliant.