Italvacuum, established in 1939, since the beginning of its history has manufactured industrial vacuum pumps and vacuum dryers used in the main production processes of chemical, pharmaceutical and cosmetics companies, realizing original and innovative solutions developed following the customer’s needs.
The flower of the Italvacuum products is represented by the CRIOX System, an international great success patent, that has been continuously improved and optimized during the years: so that today there are more than 400 units installed in more than 30 countries.
It consists of a multiproduct rotary vacuum dryer / powderer capable to total extract any kind of solvents from the wet powders coming from filtering or centrifuge: whether they are intermediates, fine chemicals, finished products even thermo-sensitive, delicate, more o less fine, degradable, photosensitive, sterile, injectable, active pharmaceutical ingredients or chemically reactive.
CRIOX 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 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 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.
The bi-conical rotating drying chamber of the CRIOX System 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. For the parts in contact with the product, the standard version of CRIOX is made of stainless steel AISI 316L (1.4404), but on request it 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, allowed also 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 other versions with enamelled drying chamber, in which the application of a special enamel, consisting of alkaline boron silicates, on the steel support, makes the CRIOX chemically inert inside.
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 lump-breaking blade sets that are the peculiar characteristic of the CRIOX System and that permit to increase the surface of the product exposed to evaporation and the effectiveness of mixing.
By acting on the core of the mass of the product to be dried, the electric lump-breaking units reduce consistently the drying time ensuring extremely low moisture levels, that often 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 System has effective filtering systems. In vacuum drying processes, the filtering unit must be able to keep all the powder in the drying 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 directly inside the drying chamber, in order to meet all process requirements: metal sintered cartridge filters or PTFE filters, suitable for very fine powders and whose effectiveness during the process is ensured by an automatic C.I.P. system for nitrogen back-flow washing.
Equipment suitable for multiple products must be above all easy to clean. Cleanability, however is not definable in absolute terms and therefore needs to be measured with more generic criteria like ease of internal washing, removal of internal parts, inside inspection and external cleaning.
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 in order to consider a plant clean, hence reducing the quantity of wastewater to be disposed of. Furthermore, inside the chamber, a C.I.P.
(Clean In Place) 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 shift rapidly from one product campaign to another.
With reference to removal of internal parts, inside the drying chamber the CRIOX System presents only the lump-breaking units, with blades that can be removed easily thanks to their small size.
Internal inspection is possible by opening the manhole port lid and the loading hopper. Moreover, in order to perform the SWAB test required by the FDA standards for the validation of the washing procedures, Italvacuum designed and patented a large hatch that permits to open completely the machine and to carry out all the required operations with extreme easiness and safety.
Regarding external cleaning, the sealed external cladding (particle-free configuration) covering insulation, electrical and hydraulic circuits makes the external cleaning very easy and effective, avoiding product deposits in recessed areas. For plants of larger size this feature also allows the "partitioning" solution, which permits to separate the clean room from the machine room.
The CRIOX System is designed to fulfil the widest possible range of needs, as far as size and configuration are concerned, being manufactured with capacity from 55 to 12.000 litres. The maximum load level depends on the nature of the product being 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 order to load and unload the product automatically, Italvacuum realized particular pneumatic systems that permit to have a fixed connecting position (i.e. centrifuge) and a movable approaching element to be connected every time to the loading / unloading opening of the CRIOX, hence creating a closed connection, perfectly insulated from the surrounding environment. The movable part can be provided with an optimized special cleaning device – called Clean Connex – consisting of a washing C.I.P. head and a draining and drying element, that after every loading / unloading operation, and before disconnection, cleans and dries the surfaces that came in contact with the product and that will be exposed to the environment. Trials carried on the loading system equipped with the new Clean Connex device show a residual concentration of the contaminant inferior to 0.09 p.p.m. (fully in compliance with FDA regulations that fix the limit of 10 p.p.m. to consider clean an installation, as indicated in the "Guide to inspections validation of cleaning process "). The Clean Connex device is patented.
For dryers of small and medium size a pneumatic drum loading device also exists; this device is very easy to be used and particularly appropriate thanks to the rotation of the chamber. For each loading / unloading solution, the flexibility of design and the peculiar configuration of the CRIOX System permits the use of both butterfly valves (standard equipment) and active or passive split
valves, that are mounted directly on the dryer.
For the product discharge, thanks to the experience gained over the years in the vacuum process application, Italvacuum realized a special total unloading device that, through its rotation permits the total removal and extraction of the dried products that slide with difficulty from the CRIOX chamber. This device – called Easy Unloading – ensures the absolute vacuum tightness and causes no problem for the internal cleaning.
In order to complete the plant installation, in addition to the CRIOX System, Italvacuum also supplies all the necessary fittings, properly sized according to any process requirement:
From laboratory scale to industry: the best way for a secure choice of the industrial installation. 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.
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