The leading product of Italvacuum’s drying technology is the CRIOX System, having achieved a great international success with more than 400 units currently installed in at least 30 countries around the world.
It consists of a multiproduct rotary vacuum dryer / pulverizer capable to perform the complete extraction of the solvents from the wet powders coming from filtering or centrifuge: whether they are intermediates, fine chemicals, finished products even thermo-sensitive, delicate, more or less fine, degradable, photosensitive, sterile, injectable, active pharmaceutical ingredients or chemically reactive.
CRIOX System is multi-purpose. It can be used as an effective fast blender or homogenizer, as well as a granulator, limiting the subsequent use of the mill as much as possible.
CRIOX System is versatile and profitable for it minimizes times required to re-establish the line, wash, clean and inspect the plant and it permits to shift rapidly from a product campaign to another.
CRIOX System is safe for the personnel, the environment and the product, for it has been designed and built in compliance with the ever more severe safety regulations and with cGMP and ATEX Standards.
CRIOX System, thanks to the bi-conical rotating drying chamber, allows the total and continuous revolution of the mass to be dried and an extremely homogeneous mixing. The chamber rotation speed is adjustable so that the agitation can be controlled from very gentle to moderate. This permits to treat even products with weak bonds, without modifying their molecular structure.
During the drying process, the CRIOX System crushes the possible blocks inside the mass and breaks the lumps that could be formed, permitting to obtain at the end of the process dry powders, with a controlled final particle size distribution, ready to be riddled and packed.
The bi-conical shape of the rotating chamber by itself could not lead to the desired results if it wasn’t for two powerful electrical lump-breaking blade sets, that are the peculiar characteristic of the CRIOX System, permitting to increase the surface of the product exposed to evaporation and the mixing effectiveness.
By acting on the core of the product to be dried, the electric lump-breaking units reduce consistently the drying time, ensuring extremely low moisture levels, that cannot be achieved by other systems. Furthermore they permit to operate at low working temperatures, for the benefit of the purity of the most delicate thermo sensitive products, as it avoids their degradation.
CRIOX is the unique rotary vacuum dryer on the market equipped with electrical lump-breakers. Advantages of lump-breakers operated by electrical motors include:
- Rotation speed control
- Programmable working cycles
- Constant torque at different speed
- Power absorption control
- Cooling by ventilation.
Furthermore electrical lump-breakers ensure:
- Reliability and long life even with heavy use
- Low maintenance.
Last but not least, the lack of pneumatic circuits prevents lump-breakers from pressurised air inside the chamber and the surrounding area.
Regarding constructive materials, for the parts in contact with the product, the standard version is made of stainless steel AISI 316L (1.4404). Moreover, on request, CRIOX System can be made of other weldable materials, such as ALLOY C-22 (2.4602) and AISI 904L (1.4539).
The particular shape of the CRIOX System, characterized by soft lines without edges and sharp corners, also allows to realize successful versions with internal coating made of particular fluorine-polymer materials, characterized by a high resistance against products containing extremely corrosive substances (acids and bases). The success obtained by these executions led Italvacuum to realize even versions with enamelled drying chamber, in which the application of alkaline boron silicates on the steel support, makes the CRIOX chemically inert inside.
CRIOX System has effective filtering systems. In vacuum drying processes, the filtering unit must be able to keep all the powder in the chamber, letting only the solvent vapours pass through. At the same time, it must ensure the lowest possible pressure drop, in order to achieve very low final pressure values. Italvacuum offers special filtering systems, placed inside the drying chamber, in order to meet all process requirements: metal sintered cartridge filters or PTFE filters, suitable for very fine powders. Filter effectiveness during the process is ensured by an automatic C.I.P. system for nitrogen back-flow washing.
Equipment suitable for multiple product applications must be, above all, easy-to-clean.
Concerning internal cleaning, thanks to the rotation of the drying chamber and the combined action of the lump-breaking units, only very few rinses, with small quantities of fluid, are necessary to achieve the p.p.m. values required by FDA standards to consider a plant as clean, hence reducing the quantity of wastewater to be disposed of. Furthermore, inside the chamber, a C.I.P. device can be applied, able to spray the washing fluid in all the directions. Thanks to this fast and complete internal cleaning, CRIOX System permits to rapidly shift from one product campaign to another.
CRIOX System is designed to fulfil the widest possible range of needs, being manufactured with capacity from 55l to 12,000l. The maximum load level depends on the product to be processed. Conversely there are no constraints on minimum batch size, since the mechanical action of the lump breaker units is effective even with a few litres of product.
In addition to CRIOX System, Italvacuum is the only manufacturer in the world able to supply all the necessary auxiliary groups, properly sized according to the customer’s process requirement, vacuum system included:
- Vacuum pump SAURUS939
- Safety external filtering unit
- Condensation vacuum unit with the tank for the recovery of extracted solvents
- Heating and cooling groups for the system thermo-regulation
- Control panel with PLC for the management of operative parameters and the drying processes, the software being compliant to CFR 21 – Part 11 norm and able to ensure reproducibility of the dried batch as well as being able to interface with centralized supervision systems
From laboratory scale to installation: the best way for a secure choice of the industrial plant
For drying trials on the customer’s products, Italvacuum has a wide range of pilot installations for semi-industrial and laboratory tests. During the trials with pilot installation it is possible to extract some product samples without breaking the vacuum and at any time vary the process parameters in order to define the ideal drying path. In this way the customer can make the best choice for the Italvacuum installation both in terms of dimension and performance.
As for the personnel of Italvacuum, they obtain the important information to adapt the industrial installation according to the customer’s requirements. The trials are completed and formalized by drawing up a detailed report with graphics referred to the development of the main parameters and conclusive considerations for the definition of the industrial plant.
- Absolute safety for the operators, the environment and the product, being designed and manufactured in accordance with European Directives CE, ATEX and in compliance with increasingly stringent FDA standards and cGMP rules
- Perfect homogeneity and uniformity of the dried batch with no deposits of product
- Scalable powdering of the product during the drying cycle
- Reduced drying times thanks to the action of lump-breaking units, which increase the surface of the product exposed to evaporation
- Very low final moisture values, in accordance with the p.p.m. limits required by pharmacopoeia
- Low working temperatures, for the benefit of the most delicate products
- Extremely high final vacuum values (lower than 0.01mbar)
- Fast and total unloading of the product thanks to the conical shape and the use of the easy unloading system
- Ease of internal / external cleaning and of inspection
- Wide availability of weldable materials and inner coatings
- Total automation of the system to guarantee process reproducibility for all batches