VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 Times for new rules in vacuum drying

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 Introduction PLANEX System®, the BRAND NEW multi product Paddle Vacuum Dryer, is a special technology studied, developed and patented by ITALVACUUM in order to overcome the peculiar limits of the traditional paddle vacuum dryers equipped with concentric agitator. PLANEX System® is based on an innovative philosophy of working, especially suitable the production of Active Pharmaceutical Ingredients, Fine Chemicals and Intermediates.

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 An absolutely new philosophy of drying PLANEX System® consists of a fixed cylindrical chamber with an eccentric agitator inside with two independent movements, able to rotate on its own axis and tangentially to the cylindrical chamber as well. The double combined rotation allows an optimal mixing of the product, continuously renewing the surface of the mass exposed to evaporation, covering all the volume of the vessel. In this way solvents release is facilitated and drying times are significantly reduced. The peculiar configuration of the agitator, characterized by a diameter much smaller than the one of the drying chamber, reduce notably the mechanical stress, preventing local overheating due to friction. This enables to treat even more delicate and thermo sensitive products, as it preserves their purity, avoiding degradation of the dried batch.

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 The working process Moment 1 Moment 2Moment 3Moment 4 The gentle working process enables to treat even more delicate and thermo sensitive products, as it preserves their purity, avoiding degradation of the dried batch. It must be remarked that the mechanical stress on the product is about three times less than the one obtained with traditional dryers that are equipped with concentric agitator. Consequently the overheating of the product, deriving from mechanical action, results considerably lower (Analysys of "Politecnico di Torino" University – Material Science and Chemical Engineering Department).

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 Ease of cleaning and inspection The inner cleaning is granted by an efficient C.I.P. system, that allows a complete washing of all the parts in contact with the product, while the big front port makes the inspection simple and practical. Also the SWAB TEST execution is facilitated thanks to the profile of the eccentric agitator and the easy dismantling of its parts, unlike in the traditional systems. The exterior of PLANEX System® can also be easily cleaned. Besides the sealed external cladding (particle-free configuration) covering the insulation material, the electric wiring and the hydraulic piping, Italvacuum implemented an original solution for supporting the drying chamber without sustainments to the floor, as on the contrary it happens with traditional dryers. In this way the external cleaning becomes very effective, avoiding accumulation in recessed areas. These features, combined with the partitioning solution, allow clean room installation, achieving the pressurization and separation of the sterile room from the machine room.

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 1.Absolute Safety for the personnel, the product and the environment according to cGMP rules 2.Perfect homogeneity and uniformity of the dried batch, obtained through the controlled action of the agitator that enables a full revolution of the product, avoiding overheating and degradation (mechanical stress is three times less compared to traditional dryers) 3.Easy and complete unloading of the product thanks to: a) profile of the eccentric agitator b) reduced gap between the agitator profile and the wall of the drying chamber c) specific unloading program managed through PLC 4.Reduced drying times thanks to the double combined rotation of the inner agitator that increases the product surface submitted to evaporation 5.Reduced power consumption (possibility of use of electric drives with high efficiency) Advantages

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 6.Extremely high final vacuum values (under 0.01 mbar) and very low final moisture values 7.Ease of washing thanks to an effective C.I.P. system that enables the liquid to circulate in every point of the drying chamber, allowing to reach residual p.p.m. requirements with very few rinsing operations 8.Ease of inspection to every point of the drying chamber thanks to the configuration of the misaligned agitator and the easy dismantling of its parts, that facilitate the SWAB TEST execution 9.Ease of external cleaning thanks to: a)the complete outer cladding b)the absence of supports of the drying chamber to the floor c)the possibility of clean room installation allowing to separate the machine room from the sterile room (Particle Free configuration) 10.FDA validation and approval 11.ATEX certification. Advantages

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 Turn-key plants Beside the PLANEX System®, ITALVACUUM provides all the necessary fittings that complete the plant in order to satisfy every process requirement: - heating and cooling group for the system thermoregulation - condensation vacuum group with tank for the recovery of extracted solvents - safety external filtering unit - high vacuum group - control panel with PLC for the management of operative parameters of the drying process.

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 PLANEX System® presents a high loading flexibility. It is manufactured with volumes from 300 to litres. The loading capacity varies from 15% to 80% of the vessel volume, allowing to treat both small and big batches, covering all the process requirements of the chemical and pharmaceutical industries. Models

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 The patent

VACUUM PROCESS INNOVATIONS SINCE 1939 Updated to November 09 ITALVACUUM S.r.l. Via Stroppiana, Borgaro (TO) - ITALY Tel Fax CONTACT