Water Treatment Systems
Together, ACIC Machinery and our partner Tecninox provide turnkey water treatment systems for the production, storage, and distribution of pure fluids for the pharmaceutical and biotechnology sectors.
We have more than 40 years of experience in the design, build, installation and validation of turnkey water treatment systems with integrated automatic control systems.
All water treatment systems are built according to the most recent GEP, ASME, FDA, cGMP, and GAMP regulations and can be customized according to customer requirements.
We provide customer support throughout the lifespan of the equipment, including after-sales support with the supply of spare parts and software service with qualified personnel to prevent production plant shutdowns.
Reverse Osmosis – ROTEC
Reverse Osmosis systems are extremely compact while providing the maximum operating space for scheduled and special maintenance operations. Optimal vision of all the operating and process parameters are guaranteed in full respect of ergonomics and safety guidelines. The ROTEC system’s production capacity and quality parameters remain consistent regardless of the physical and chemical characteristics of the feed water.
After undergoing pre-treatment microfiltration and duplex softening, the feed water enters the break tank at a pre-set level. It is taken from the storage tank by a high-pressure pump through the temperature control system to the first reverse osmosis pass. Part of the water is then discharged and recirculated back to the pump (concentrate), while the permeate is sent to the high-pressure pump of the second stage or to the polishing stage by means of electrode ionization (upon selection). The following operation is similar to the previous one. The concentrate is returned to the break tank to restart the normal operating cycle. The water produced by the unit will be delivered to the PW tank then distributed in the loop to the points of use of the system located in the various departments/users. The system is equipped with two separate in-line dosing control units: one control unit with diluted caustic soda and the other with sodium metabisulphite. Systematic process control is performed by a master electrical switchboard using a PLC with display and control of critical process parameters such as conductivity, pH, flow rate, temperature, and pressure, to guarantee the treated water quality according to the required standards. The control board is equipped with a communication card for interfacing with the external supervision systems.
Compliance with cGMP requirements
The treated water meets the 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 case of final polishing after reverse osmosis stage the above-mentioned capacity should be considered 10% higher.
We are able to supply the plant with any type of operating control you require starting from local instrumentation with manual control, up to DCS or SCADA fully integrated system. Temperature, conductivity, flow, TOC are considered our windows to the process, and 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.
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
- 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 provides technical and maintenance support to meet every specific requirement.
Multi–Effect Distiller – DITEC
TECNinox water distillers belong to the last generation of multi-effect distillers. The system ensures a reliable and automatic production of pyrogen-free and high-quality Water For Injection. Our computer-aided design with 3D modelling, is constantly updated according to the latest heat transfer technology. Distillation columns comply to ASME International rules and PED rules, including other design procedures requested by specific countries.
Principle of operation
The distillation process consists of water steaming, followed by steam condensation, to eliminate the most volatile or non-volatile impurities at water boiling temperature. Multi-effect distillation process includes several ‘effects’ in which evaporation and condensation usually occur at the same time. Feed water evaporates in columns consisting of tube condensers and decontamination chambers, which are joined by a flange connection, and have differing pressures and a decreasing temperature. The first effect is fed by an external heat source; in the subsequent effects this energy is totally reused and is therefore energetically self-sufficient. There are generally 3 to 7 effects included. An increasing number of effects reduces operative costs thanks to a greater percentage of recovered energy as compared to the initial 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 to produce Water for injection (WFI) according to cGMP good manufacturing standards in compliance with the European Pharmacopeia and USP guidelines.
- Integral pre-heating coil, a new design due to lengthy research and experience
- Falling film feed system with an instantaneous flash evaporation effect to improve evaporation efficiency
- Water droplet separation based on a combination of multiple physical factors
- Pure steam production at first effect in alternation, or while producing CS
- Automation and control: the system is controlled by industrial PLC based on HMI interface
WFI Production Capacity (l/h) *
with Plant Steam @ 8 bar
with Plant Steam @ 6 bar
with Plant Steam @ 3 bar
Dimensions and Weight **
Width x Depth x Height x Weight
1400 x 1000 x 2600 mm
1650 x 1100 x 2600 mm
2200 x 1100 x 2600 mm
2000 x 1200 x 2900 mm
2500 x 1200 x 2900 mm
3000 x 1200 x 2900
2500 x 1400 x 3300 mm
2800 x 1400 x 3300 mm
3200 x 1400 x 3300 mm
3000 x 1500 x 3600 mm
3300 x 1500 x 3600 mm
3600 x 1500 x 3600 mm
2550 x 1500 x 4200 mm
3300 x 1500 x 4200 mm
3600 x 1500 x 4200 mm
3300 x 1500 x 4200 mm
3600 x 1500 x 4200 mm
4400 x 1500 x 4200 mm
3500 x 1600 x 4400 mm
4150 x 1600 x 4400 mm
4800 x 1600 x 4400 mm
5450 x 1600 x 4400 mm
4500 x 1700 x 4400 mm
5200 x 1700 x 4400 mm
5900 x 1700 x 4400 mm
5300 x 1700 x 4400 mm
5900 x 1700 x 4400 mm
6500 x 1700 x 4400 mm
*The above data have a tolerance of ± 5%.
** Maximum dimensions.
The drawing up and filling in of validation records allows us to offer our customers the complete package in 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 continue 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. A 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 upon request in accordance with the pharmaceutical application standard and consist of:
- FAT protocol
- IQ/OQ protocol
Pure Steam Generator – GVP
The Pure Steam Generator is designed for the production of sterile, pyrogen-free pure steam. This high purity steam is suitable for the sterilization (S.I.P.) of equipment components like tanks, preparation vessels, piping systems, filling machines, filters, and for humidifying of cleanrooms.
Principle of operation
The feedwater, pressurized by the feeding pump, circulates through a pre-heater (optional) to increase the feed water temperature, the water goes into the evaporator column and then to the main exchanger – pipes side. The high temperature of industrial steam (shell side) heats 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.
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. 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.
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.
Internal surface of under pressure container can be electropolished with a Ra=0.3-micron finishing.
It is available on request to manufacture the control cabinet and the framework in AISI 304 stainless steel.
The steam generator can be equipped with condensing unit for production of very high-quality distilled water for injection. (WFI)
The sampling unit is composed by a cooling exchanger to condense steam and take a sample.
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. It is including by:
- FAT protocol
- IQ / OQ protocol
Storage and Distribution System – LOOPTEC
LOOPTEC is a pre-assembled skid mounted unit, that includes all equipment and control components for the loop management over the service, as well as a sanitization/sterilization phase. The control panel is located on board of the unit with the relevant PLC and HMI. The Inlet water comes from the storage tank, then is pressurized and recirculated in the distribution loop. The loop return is equipped with heat exchanger and instruments such as temperature, pressure, TOC, flow rate and conductivity to control the critical service parameters before driving the recirculated water into the storage tank.
Uses of water in pharmaceutical and biotechnology.
- Cytotoxic preparation
- Haemofiltration hemodiafiltration solution
- Peritoneal dialysis solution
- Irrigation solution
- Nasal/ear preparation
- Cutaneous preparation
- Buffer preparation
- Oral preparation
- Clean in place process
Storage and Distribution system
TECNinox has a vast experience in design, supply, installation, and validation of purified water, WFI distribution system. 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.
TECNinox 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, and 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.
From 3 L up to 20,000 L, we are able to satisfy customer demands for PW and WFI systems. Supported by in-house design, production, and quality control, Tecninox is able to supervise unparalleled and guarantee solutions that satisfy the most stringent requirements.
Our processing techniques have enabled us to reach a roughness lower than 0.10 μm in mechanically cleaned test containers. With electropolishing and/or passivation treatments we are capable of achieving roughness ranging from 0.15 to 0.28 μm on all surfaces when required.
The materials delivered by TECNinox comply with 3A-FDA standards, such as for example the bottom-flush valves, with started flow and the magnetic entrainment mixers, “SANITARY TECNINOX®”, that can be used for tanks up to 3,000 liters. These mixers do not require any flow breakers and are ideal for mixing even small product quantities. At TECNinox, we have the capability to manufacture in accordance with cGMP to ensure validation. Our manufacturing processes are quality controlled and documented from purchase of raw materials to finished products. Designs are developed for I.S.P.E.S.L., T.Ü.V. and S.V.T.I. standards. We provide you with all technical documentation necessary for obtaining FDA approval.
Automated C.I.P. and S.I.P. are currently the best methods for cleaning/sterilizing processing systems. They ensure safety and efficiency, remove residues, prevent product contamination, and minimize recontamination of the process.
PROCESS MORE PRODUCT – by installing a C.I.P. system you can achieve continuous use of your processing equipment by minimizing system shutdowns for cleaning.
MAINTAIN QUALITY – an efficient cleaning minimizes potential contamination.
SUSTAIN SANITARY INTEGRITY – a C.I.P. system is a closed loop where sanitary conditions are easier to maintain, safe operation is enhanced, and maintenance cost are reduced.
C.I.P. systems are used wherever product must be kept pure such that residue shall not appear in the next product processed. All TECNinox C.I.P. systems and components are designed to meet or exceed 3A sanitary standard and cGMP guidelines. Among the industries where C.I.P. systems are used:
Eductor motive return system
An eductor system works on the Venturi principle: water is forced by a dedicated pump into an eductor that creates a vacuum that pulls the C.I.P. solution out of the system being cleaned.
To avoid the expense and reduce the cost of installing a large fixed C.I.P. system, TECNinox manufactures portable C.I.P. units. The system is compact and is designed to be self-draining while meeting a high-quality standard. The unit can be equipped with electrical heating device or a heat exchanger.
Flow rates, temperature, pressure, level, and conductivity are some of the control parameters to keep your C.I.P. system efficiency and reliable. TECNinox offers the latest in control system hardware and software. Real time information is displayed on an operator interface. The C.I.P. unit can be controlled through an industrial system bus via a communications processor.