We have parameters used in sterilization, such as: gas concentration 170 g. Cartridges armored with 100% ethylene oxide. Temperature 55 ° C. Humidity greater than 35% relative humidity. Exposure time 3:30 hours of sterilization, 2 hours of aeration.
Our equipment has physical control of the sterilizer. This performs a graphic record of the cycle documenting that the sterilizer has reached the required vacuum, temperature, humidity and pressure.
We also have chemical control. An external chemical indicator of the package: documents in each package the correct functioning of the sterilizer. Internal chemical indicator of the package: documents that the sterilizing agent has penetrated inside the package. It is used in each cycle within a test package that is opened in the plant at the end of the cycle to release the material without waiting for the results of the biological indicator.