UNILENE, is a company that specializes in serving low-temperature sterilization by Ethylene Oxide, with capacity to serve up to 10,000 liters per day. Fact approved by the ISO 9001 international certification for its process management system. It is also recognized by the Peruvian Health Authority
It is a type of chemical sterilization, based on the use of a sterilizing agent called Ethylene Oxide. It is used in the medical field for over 60 years and is a method of sterilization recommended as ideal for those elements that cannot be sterilized using traditional techniques of heat and/or steam.
It is the most appropriate method for sterilization of delicate surgical instruments, optical instruments, many plastics and other expensive materials or heat sensitive.
Materials that can be Sterilized:
Plastic Sensitive gums Optical Instrumentation Electrical Material Delicate instruments Implants Prosthetics
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
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.