The system has documentation, which certifies not only the failure codes but also the process profile, indicating time, accurate relative humidity, verification through a biological indicator of product sterility (individual per load) and an advanced own verification technique of Ethylene Oxide traces which certifies that the materials are suitable for delivery to our customers and thus be used by users and patients in institutions.
To ensure proper sterilization of products supplied by the plant uses a series of controls:
- Indicador químico externo del paquete: documenta en cada paquete el correcto funcionamiento del esterilizador. Physical control of the sterilizer, graphic record of cycle documenting that the sterilizer has reached the proper vacuum, temperature, humidity and pressure.
- Product control:
- External chemical indicator of the package: documents in each packet the proper functioning of the sterilizer.
- Internal chemical indicator of the package: documents that the sterilant has penetrated inside the package. It is used in each cycle in a test package that opens into the central of the cycle end in order to release the material without waiting for the results of biological indicator.
- Load Control (ensuring the effectiveness of the process):
- Biomarker: documenting the elimination of microbial life (or spores bacillus subtilis Stearotermophilus) of the sterilized items. It requires 24-48 hours to check growth (-) of the spore, although they are introducing other quick reading that check verifying the growth in 1 to 4 hours.
Before storing the sterile material is cooled to avoid condensation and packaging is verified for maintaining its integrity, the external chemical controls are correct and the package is properly identified.
Materials that can be Sterilized
- Sensitive gums
- Optical Instrumentation
- Electrical Material
- Delicate instruments
Parameters used in sterilization
- Gas concentration: 560mg / L
- Temperature: 45 º C.
- Humidity: Relative humidity over 40%.
- Exposure time: 12 hours of gasification, 4 hours of ventilation