HYDRA LINEAR WASHING MACHINE

Transcription

1 HYDRA LINEAR WASHING MACHINE

2 LINEAR WASHING MACHINE FOR VIALS AND BOTTLES IMA LIFE Hydra washing machines are the result of years of research and development dedicated to the decontamination of containers for injectable products. The machines are entirely made of 304 or 316l stainless steel and have been designed according to the cgmp guidelines, thereby satisfying the highest quality standards of the pharmaceutical industry. A range of machines is available for all vial sizes used by the pharmaceutical industry at speed of up to 34,000 vials per hour. The machines can also be used for washing plastic containers and, upon request, for oval ones. Hydra can be equipped for direct connection to automatic container feeding systems (such as depacking or inspection machines) or for connection to feeding conveyors. Hydra machines can discharge into trays or can be connected to a depyrogenating tunnel by means of a special first-in first-out off-set loadingsystem. The standard version is equipped with 8 washing stations. This number can be increased up to 13 stations upon request. A special upper guide rail allows the washing of containers at high media pressures without vibration or movement. The machine drives are easily accessibile and completely segregated from the process areas in order to avoid the possibility of crosscontamination. A system of levers incorporating spring-loaded telescopic overloads drive the mechanical movements of the machine, including the raising of the washing needles. This avoids the risk of vial breakage and a consequent contamination by glass particles. DECONTAMINATION TECHNOLOGIES.

3 The washing cycle can be designed according to the nature of the container and to customer s specifications. A 3 log endotoxins reduction can be achieved for terminal sterilization applications.

4 LINEAR WASHER STRICT CRITERIA FOR DECONTAMINATION HAVE BEEN APPLIED TO MACHINE DESIGN.

5 During washing, the water pressure in the needles lifts the vials in their baskets to allow the flow of water around the external surface of the vials. The containers are loaded onto the in-feed conveyor of the washing machine either by the operator or by a depacking machine. The conveyor pushes the containers up to the separating group where an elevator takes the leading row of vials and introduces them into their corresponding baskets. There is a check to verify that all the containers have been correctly introduced into their baskets. STANDARD WASHING CYCLE The carriage where the washing needles are mounted moves vertically. Only when the needles are inside the vials the dedicated media valves open. Upon completion of the washing cycles, the baskets stop in a horizontal position. The vials are pushed out of the baskets onto a cradle which lifts the vials to a standing position on the discharge plate. This process assures all vials are positively discharged from the baskets and no contaminated water in the baskets drips into the vials. The three areas of the machine - process, media circuits and drive are segregated in order to avoid the risk of cross-contamination. Many options are available to meet particular requirements: automatic drainage, steam in place, temperature recording, steaming stations, siliconising stations, double media recycling and s.o. The washing cycle guarantees a 3 log particle reduction.

6 LINEAR WASHER POSITIVE VIAL UNLOADING. THE SYSTEM PREVENTS UNCONTROLLED WATER DROPS FALLING INTO THE VIALS. Vacuum assisted positive discharge system for unstable small vials The in-feed group, with or without ultrasonic bath, is equipped with a conveyor made of a plastic material carried by side chains. The simplicity of the in-feed group makes the tool-less changeover quick and eliminates the need for adjustments. Gentle movements with overload devices limit the mechanical forces exerted on the vials. It is possible to automatically reject fallen vials during smaller vial size running.

7 The positive unloading system prevents water dripping into the vials. The automatic discharge allows the washing machine to be emptied and every vial to enter the tunnel without operator intervention or without the need for additional tools. WE CAN SUPPORT CUSTOMERS WITH TRAINED STAFF, INSTRUMENTATIONS AND LABORATORIES TO PERFORM VALIDATION TESTS DURING FAT AND SAT OPERATIONS. The ultrasonic bath for vials can be installed on all models of the Hydra Series of vial washers. The unit has been designed according to the latest cgmp guidelines and allows an easy accessibility for the operator and a quick maintenance. The size change over is highly ergonomic and eliminates the need for adjustments.

8 HYDRA TECHNICAL DATA Length (mm) Width (mm) Height (mm) April LF FORMAT RANGE TYPICAL BASKET NUMBER OF BASKETS PER ROW MACHINE MODEL PRODUCTION: PCS/HOUR 9 Hydra A mm 110 mm mm A 17 Hydra A Hydra A Hydra A Hydra B mm 110 mm mm B 13 Hydra B Hydra B mm 10 mm 10 mm 110 mm 180 mm 180 mm mm C mm D mm I 23 Hydra B Hydra C Hydra C Hydra C Hydra C Hydra C Hydra D Hydra D Hydra D Hydra D Hydra I Hydra I Hydra I Hydra I 9900 The above production data & format ranges refer to standard machines with a single size of washing basket. By replacing the baskets, each row of which is mounted on a single carrier, it is possible to accommodate container sizes outside the indicated format ranges. IMA S.p.A. reserves the right to make any changes to the described machine characteristics. IMA S.p.A. IMA LIFE division Via Emilia Ozzano dell Emilia (Bologna) - Italy Tel Fax mktg.life@ima.it -