Validation of the Ethylene Oxide Sterilization of Polypropylene Disposable Syringes

Abstract

The current study describes the efficiency of the sterilization method by mixture of 30% ethylene oxide and 70% CO2 gas in a single cylinder its capacity 25 kg for single-use polypropylene syringes. The sterilization process was performed within six hours at 53°C to 54°C, pressure of 1320 ml bar and relative humidity of 60%. The chemical and biological indicators were removed from the cartons after completing the sterilization process. The results of the chemical test gave a change in the color of the chemical indicators tape which adhesive on the surface of each carton from yellow to orange. The chemical indicators strips which are packaged with the syringes changed from red to green that means indication of the sterilization process successfully. The result of the biological indicators (a bacterium called Bacillus atrophaeus placed in special tubes in prepared conditions containing special food). The biological indicators placed for 48 hours on a special instrument containing an incubator and an ultraviolet light bulb to detect the presence of bacteria. The instrument gave a negative result (green light) to indicate the absence of bacteria or bacterial growth and this indicated the success of the sterilization process and the efficiency of sterilization method by ethylene oxide gas effective for medical products, especially for medical syringes.