The machine type CPE are particularly designed for the complete process (from dirty to ready to be sterilized or ready to be used) of pharmaceutical closures such as rubber stoppers, rubber pistons, rubber seals, plastic parts, aluminum caps, combi-seals, etc.
Pre-selected and custom made programs for any need. The machining process is developed by our Automation Department following the current codes/standards and type of product to be processed. The process consists of the following events: fluid bed pre-washing, fluid bed de-latching, fluid bed washing with or without chemicals, fluid bed WFI pulsed rinsing, fluid bed siliconization, steam sterilization at 121 °C, hot air drying (HEPA 14 filtered).
During product cleaning (pre-washing, washing, and rinsing) a water fluid bed and air bubbles are created by the action of a sanitary recycling pump. This combination of events captures the particles contained in the product and move them in suspension on the water. Then the same pump built up and overflow for skimming out all those particles. In the end, each phase the water of the fluid bed is completely drained out and an automatic machine cleaning in place (CIP) is run. During the phase of product washing, chemicals may be injected through an accurate and reliable system to improve the cleaning action of the machine.
The de-latching is normally processed between the pre-washing and washing phases basically to “exhaust” all chemical residuals contained in the product. This phase consists of loading the water into the chamber and a further injection of clean steam though a PID controlled valve. The consequence of such a combination of events made it possible to built up overheated water which “purify” the product.
Product siliconization by means of a combination of water fluid bed and injection of silicone. The silicone is dosed upstream of the water recycling pump through an accurate and reliable system that allow the perfect distribution and avoids any stratification. At the end of the process, the water of the fluid bed mixed with the silicone is completely drained out and an automatic machine cleaning in place (CIP) is run.
Product sterilization by means of Fractioned Vacuum process (removal of air through alternative pulses of vacuum and injection of clean steam). After the removal of all air, the steam is injected into the chamber through a PID controlled valve at the desired setpoint value and the condensate is continuously evacuated through the drain for guaranteeing an excellent distribution of the heat during all exposure phase (temperature deviation below ± 0.4 °C). At the end of the exposure, the steam is evacuated by means of a vacuum brake filter and vacuum pulses.
Drying of a product means of blowing into the chamber a large quantity of hot clean air. Cleaning of air by HEPA 14 or Cartridges 0.2 µm filtering unit. Air heating by electrical elements or heat exchanger of multi-tube double-head type. At the end of the process, fresh air is injected to cool down the product.