Products
Water-for-Injection Generation
Our partners 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.
Product Lines
DITEC: Water-for-Injection Production
C.I.P. – Clean in Place System
DITEC: Water-for-Injection Production
Multi–Effect Distiller – DITEC
Our water distillers belong to the latest generation of multi-effect distillers. These automatic systems reliably produce pyrogen-free and high-quality Water For Injection. Our 3D modelling software-aided designs are 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.
Principles of operation
The distillation process consists of water steaming, followed by steam condensation, to eliminate the most volatile or non-volatile impurities at water’s boiling point. The 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.
DITEC application
The fine chemical, biotechnology, and pharmaceutical industries need to reliably 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) * |
|||
|
DITEC Models |
with Plant Steam @ 8 bar |
with Plant Steam @ 6 bar |
with Plant Steam @ 3 bar |
|
250 |
250 |
200 |
130 |
|
500 |
500 |
400 |
280 |
|
750 |
750 |
670 |
400 |
|
1000 |
1000 |
830 |
530 |
|
1500 |
1500 |
1250 |
800 |
|
2000 |
2000 |
1600 |
1100 |
|
3000 |
3000 |
2500 |
1650 |
|
4000 |
4000 |
3300 |
2200 |
|
5000 |
5000 |
4150 |
2720 |
|
6000 |
6000 |
5000 |
3720 |
|
Dimensions and Weight ** Width x Depth x Height |
|||||
|
DITEC Models |
4 effects |
5 effects |
6 effects |
7 effects |
8 effects |
|
250 |
1400 x 1000 x 2600 mm 750 kg |
|
|
|
|
|
500 |
1650 x 1100 x 2600 mm 860 kg |
2200 x 1100 x 2600 mm 1000 kg |
|
|
|
|
750 |
2000 x 1200 x 2900 mm 1000 kg |
2500 x 1200 x 2900 mm 1200 kg |
3000 x 1200 x 2900 mm1400 kg |
|
|
|
1000 |
2500 x 1400 x 3300 mm 1200 kg |
2800 x 1400 x 3300 mm 1400 kg |
3200 x 1400 x 3300 mm 1600 kg |
|
|
|
1500 |
3000 x 1500 x 3600 mm 1500 kg |
3300 x 1500 x 3600 mm 1800 kg |
3600 x 1500 x 3600 mm 2000 kg |
|
|
|
2000 |
2550 x 1500 x 4200 mm 1900 kg |
3300 x 1500 x 4200 mm 2300 kg |
3600 x 1500 x 4200 mm 2800 kg |
|
|
|
3000 |
|
3300 x 1500 x 4200 mm 2700 kg |
3600 x 1500 x 4200 mm 3400 kg |
4400 x 1500 x 4200 mm 4000 kg |
|
|
4000 |
|
3500 x 1600 x 4400 mm 3000 kg |
4150 x 1600 x 4400 mm 4000 kg |
4800 x 1600 x 4400 mm 5000 kg |
5450 x 1600 x 4400 mm 6000 kg |
|
5000 |
|
|
4500 x 1700 x 4400 mm 5000 kg |
5200 x 1700 x 4400 mm 6000 kg |
5900 x 1700 x 4400 mm 7000 kg |
|
6000 |
|
|
5300 x 1700 x 4400 mm 6000 kg |
5900 x 1700 x 4400 mm 7000 kg |
6500 x 1700 x 4400 mm 8000 kg |
*The above data has a tolerance of ± 5%.
** Maximum dimensions.
Support
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.
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. 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 will consist of:
- FAT protocol
- IQ/OQ protocol
C.I.P. – Clean in Place System
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.
Advantages
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 – 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.
Applications
C.I.P. systems are used wherever product must be kept pure such that residue shall not appear in the next product processed. All C.I.P. systems and components are designed to meet or exceed 3A sanitary standard and cGMP guidelines.
Industries where C.I.P. systems are used:
- Pharmaceutical
- Chemical
- Food/Dairy
- Biomedical
- Veterinary
- Cosmetic
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.
Portable
To avoid the expense and reduce the cost of installing a large fixed C.I.P. system, we manufacture 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.
Operating Control
Flow rates, temperature, pressure, level, and conductivity are some of the control parameters to keep your C.I.P. system efficiency and reliable. We offer 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.
