The constant request of complete packaging lines led OMAS TECNOSISTEMI to design a range of machines suitable for sterile products ranging from the bottle washer machines and the depyrogenation tunnels to the single pitch or continuous motion monobloc for filling, stoppering and closing the aluminium capsules suitable for liquid products and powders according to the requirements given by the market. The continuous motion aseptic process ensures relevant advantages compared to the process in batch; this is because the process is automatic and it guarantees the decontamination from microorganisms and particles of endotoxins.
The system proposed by OMAS is composed by a bottles washer Mod.GRW, designed and manufactured according to the GMP guide lines and in order to offer maximum versatility and efficiency.
The system uses filtered water for the first stages and pure water for the final phase. This reduces the waste, while the intermittent motion reduces the quantity of water used to not more than 3L. per minute. The not penetrant nozzles ensure the total absence of breaking and the perfect integrity of the glass; the range of vials goes from 1 to 500ml. with a speed up to 200 bpm according to the format. All the contact parts with the product are made of stainless steel 316L. while the frame is made of stainless steel 304 (sanitary piping and connections are electro-polished), thus ensuring a very efficient process of washing of the vials. The recipes of the change over can be selected from the PLC and can be selected from a easy-friendly touch screen.
Furthermore the quick release system of the change over contact parts ensures a fast change over time. The whole system is controlled by servo motors, the automatic discharge system at the end of the washing cycle directly led to the sterilization tunnel by means of hot water. In the tunnel of depyrogenation the automatic process does not require the intervention of the operator and guarantees the absolute decontamination: fast, flexible and efficient, it lasts less than 30 minutes.
The sterilization tunnel is composed by three rooms (pre-heating room, sterilization room, and cooling room) that are separated by doors and the height is automatically adjustable from the PLC as part of vial recipe.
The working temperature of the room is 320°C and this ensures the destruction of the bacteria population. A HEPA filter is installed inside of the frame of the machine. Each room of the tunnel is endowed with the disposition to carry out the test of the HEPA filter demonstration and the particles counter.
Omas aims to develop a new department for the manufaturing of machines destined to the pharmaceutical industry also considering that a new production area of 4000 sq.m. will be ready by the end of the year.
In this way, the total area will reach 10.000 sq.m thus ensuring a always wider and more qualified offer.