Among the lines manufactured by Marchesini Group dedicated to liquids, role leader at "Achema 2009", will be the new ampoule line consisting of the continuous rotary washing machine for ampoules WRA24-8, the new depyrogenation tunnel with sterilisation of the cooling chamber model NLT60S-C and the ampoule filling-sealing machine RSF24, equipped with 8 dispensing pumps.
The leader of the line is machine model WRA 24-8 produced by Corima, a continuous rotary washing machine – for ampoules and vials – with gripper conveyance system. The external parts of the machine are made of stainless steel, the rigid parts in contact with the washing fluids are made of stainless steel AISI 316L and finally the flexible parts are made of rubber approved for pharmaceutical use.
The machine offers important features: Automatic loading: automatic selection and transfer of the containers to the conveyance grippers by means of a loading star wheel. Internal and external washing and drying: the cleaning cycle, which can exploit three different fluids, is made up of 8 internal cleaning stations of the containers, two of which are installed on this machine (Water for Injectables – WFI and Compressed Air). The needles raise and penetrate the container and, following the continuous motion, they each perform their own washing or blowing functions. The sequence of cleaning fluids to be used can be chosen based on the specific process requirements, keeping the circuits strictly separate. Control of the cleaning fluid spray time: the opening times of the feeding valves of each washing fluid can be programmed from the operator panel and enable the optimisation of fluid consumptions. Automatic unloading: by means of an unloading screw with continuous motion.
The washing machine is then connected in-line to the new depyrogenation tunnel with sterilization of the cooling chamber, model NLT60S-C produced by Neri that belongs to a new series of depyrogenation tunnels with laminar flow of hot air for ampoules or vials, having amongst other functions, also the peculiar function of automatically sterilizing the cooling chamber.
The cooling chamber is sterilized by a flow of air heated by a special set of heating elements made of stainless steel AISI 316 L, installed within the circulation lines. The depyrogenation tunnel and the cooling chamber are both insulated with double walls to guarantee thermal isolation from the external environment. While the cooling chamber is being sterilized, to save Energy, the hot air circulation system automatically works in recycle mode. During the sterilization cycle of the cooling chamber, the outlet of the tunnel is automatically shut-off by a hermetically sealed hatch, which separates the inside of the machine from the sterile chamber or from the isolator. The tunnel is equipped with an automatic compensation system of pressure peaks in the sterile chamber, which is automatically disabled during the sterilization function of the cooling zone. A silicone Hepa filter is installed in the cooling chamber, for high temperatures, which can work continuously under a flow of air at 250°C.
How does the tunnel work? The cooling chamber is sterilized when the tunnel has completed the normal treatment of a batch of ampoules or vials. The sterilization process of the cooling zone (time/temperature cycle) is set on the Operator Terminal and is programmed to guarantee the correct sterilization of the whole cooling chamber, especially points in which it is quite difficult for the flow of hot air to reach, which are consequently normally "colder". The probes that control the heat-regulation function are installed in these points. During the sterilization cycle of the ampoule or vial cooling zone, the probes that control the process must ensure that the minimum temperature of 170°C is reached and held at such level for the whole time necessary to reach a bacterial reduction of 6 Log.
The sequence of the sterilization cycle of the cooling chamber is completely automatic and is performed as follows: the insulated ampoule outlet hatch is closed, which separates the tunnel from the sterile chamber; the sealing gasket of the hatch is inflated with sterile compressed air; the liquid in the cooling battery is drained; the by-pass that recycles the air is opened; the air expulsion line is closed; the heating elements are switched on: the set temperature is reached and is held for the time required to ensure correct sterilization.
When the sterilization cycle of the cooling chamber is complete, the recycling by-pass is automatically shut-off and the hot air expulsion line is opened again; in this way, the temperature lowers gradually and, at the end of the cooling phase, the machine is ready to receive the ampoules or the vials again to be depyrogenated.
Finally, the ampoules are fed to the ampoule filling-sealing machine RSF24, produced by Corima; this versatile, fast and reliable machine is equipped with 8 dispensing pumps and is very easy to service and clean. The machine features cutting edge technical solutions to meet the highest of quality standards in the pharmaceutical industry: studied and designed to ensure the highest levels of cleanability of machines for this market, model RSF24 guarantees maximum effectiveness of the air flows used to protect the product during the filling phase. All exposed parts are made of stainless steel AISI 316 or they are made using plastic materials suitable for the requirements of the workplace. Special care was also taken in designing the feeding circuits of the sealing gases in order to satisfy the highest of European safety requisites.
Servo motors are used to drive the main movements of the machine because they guarantee versatility and repeatability of all the functions assigned to the machine and to its control system. Some of the movements driven by servo motors worth a mention are those of the dispensing needles, of the pumps, of the flames and those of the grippers that tear-off the glass trims, because these are indeed the movements that control the two main functions of the machine: on one hand, product dispensing during the filling phase and on the other, closing and forming of the tip of the ampoule during the sealing phase. These solutions not only guarantee the perfect repeatability of the functions carried out, but also ensure the possibility to process liquids with special chemical-physical characteristics or glass containers with just as unusual characteristics.
SOURCE: Marchesini Group S.p.A.
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