Complete processing
IMA, the Italian machinery company, has a complete processing line for the aseptic production of drugs. This includes a Libra Hydra linear washing machine, a Libra Blue Galaxy sterilisation tunnel and the IMA Sterifill F2000, the new high-speed in-line filling and stoppering machine.
The Libra linear washing machines are used to decontaminate containers for injectable use, and have been designed according to GMP recommendations. They can be used to treat all types of vials used in the pharmaceutical industry, with vial speeds up to 34,000 pieces/h. Hydra machines can be also used for the washing of plastic containers and upon request for oval or elliptic containers. Unloading is available onto trays or with connection to rotary tables or to depyrogenation tunnels by means of a special off-set unloading system.
Blue Galaxy is a vapour phase hydrogen peroxide (VHP) sterilisation tunnel for insertion in a production line that requires continuous depyrogenation by means of dry heat. Precise distribution and penetration of heat is achieved by means of a flow of hot air treated with HEPA filters, which strikes the bottles with vertical laminar motion. Class M3.5 air, as per federal standard 209/e, is guaranteed along the entire path.
The heat treatment can be set according to the container to be treated, and guarantees a reduction of endotoxins greater than 3 log. All instrumentation can be fitted with devices for easy adjustment and calibration, while process parameters can be set and recorded according to the container to be treated. Technical specifications and technological characteristics guarantee stability of set temperatures in time and space.
With continuous motion positive transport system, the Sterifill F2000 is suitable for filling liquid solutions into cylindrical vials and for insertion of rubber stoppers. The machine works at very high speed (up to 600 vials/min), and is designed for drugs processing in aseptic conditions either in traditional class 100 areas or in isolation technology at very high speed.