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Easy to Clean…
Designed to meet stringent modern standards including cGMP and Atex, the standard Criox uses stainless steel 316L (1.4404) for parts in contact with the product. On request, Italvacuum can supply units made in other weldable materials such as Hastelloy C-22 (2.4602) and AISI 904L (1.4539). The drying unit’s gentle curves, without edges and sharp corners, allow various linings to be used to resist highly corrosive conditions. Fluoropolymer or borosilicate glass lining provides the ultimate in corrosion resistance.
In vacuum drying it is essential to keep all the powder within the drying chamber by using filters. Solvent vapours, nevertheless, must pass through with the lowest possible pressure drop, so that the dryer can operate at a low final pressure. The Criox offers various cartridge filters of sintered metal or PTFE, housed directly inside the drying chamber. The filter elements can be cleaned with an automatic controlled reverse flow of nitrogen.
Equipment used with multiple products must above all be easy to clean: thanks to the rotation of the drying chamber and the combined action of the lump-breaking units, just a few rinses with small quantities of fluid are necessary to yield FDA standards of cleanness. In addition, this cleaning procedure leads to only small amounts of wastewater. If true CIP is required, the drying chamber can be permanently fitted with a spray ball to provide rapid and complete cleaning.
The loading hopper can be opened for internal inspections and the hatch provides easy access to all parts of the chamber. It is big enough to remove the lump-breaker blades, if necessary. The insulation, electrical and hydraulic circuits on the outside of the machine are covered with sealed cladding, providing a smooth, non-shedding surface. For larger units this feature also allows to partition between a clean room and the machine room.
…and Easy to Load
For hygienic automatic loading and unloading of the product, Italvacuum has developed a specialized connection system that provides a high degree of isolation and can be equipped with CIP technology. Trials with the patented “Clean Connex“ CIP solution device showed a residual product concentration of less than 0.09 ppm, fully in compliance with FDA regulations. For comparison, the FDA considers equipment to be clean when the contamination level is below 10 ppm.
For small and medium-sized units, a pneumatic drum loader is available from the manufacturer. For both types of loading and unloading system, the user can choose between butterfly valves (fitted as standard) or split valves (active or passive) mounted directly on the dryer. For discharging products that are inclined to stick to the inside of the dryer Italvacuum has developed their “Easy Unloading” technology.
Turn-key plants
In addition to the dryer Italvacuum also supplies all the units necessary for the plant, adequately dimensioned in order to meet every process requirement:
- heating and cooling unit for the thermal regulation of the system;
- vacuum condensing unit with tank for the recovery of the extracted solvents;
- external safety filter;
- high vacuum unit based on new Saurus939 vacuum pump;
- control panels with PLC for the complete management of the plant, provided with software which could be certified according to CFR 21 Standard, Part 11, and able to ensure the reproducibility between the dried batch and connectable to centralized supervision systems.
Ready for Testing
Italvacuum has a wide range of pilot installations for semi-industrial and laboratory tests. During these tests, product samples can be extracted from the process without breaking the vacuum and the process conditions can be varied at any time in order to define the ideal drying path. In this way the customer can make the best choice both in terms of size and performance.
* The author is Marketing Manager of Italvacuum.
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