All-in-one - Customed cycle - Mix cycle - Batch Release - Validation
The peculiarity of the sterilization cycles at Medistri SA is to make all the phases of conditioning, sterilization and desorption in the sterilization unit in order to guarantee the integrity and the homogeneity of your sterilization lot.
The products that leave the chamber are thus at once ready to use.
Having adopted the highest standards of quality assurance, we can make vary the different parameters of our cycles in order to answer the specific needs of our customers and in order to respect the constraints of products to be sterilized.
According to products, it can result an accelerated procedure, a shorter duration of cycle or a faster liberation of products.
To insure a faster launch on the market and a decrease of the sterilization costs, Medistri developed a mixed cycle. This procedure authorizes the sterilization of several different customers in the same cycle.
To guarantee the level of sterilization, these products must be validated using a reference load considered to be very unfavorable.
Medistri SA offers 2 options:
With this method, approved by the Food and Drug Administration (FDA) and recognized by the Association for Advancement of Medical Instrumentation (AAMI), the sterilization is made under control which allows establishing specific ranges for the key-parameters. The concentration of gas is directly measured in the sterilization chamber.
This method is the commonly-used method. It consists in using biological indicators which demonstrate the lethality of the cycle. These indicators are especially developed to guarantee the sterilization assurance level (SAL) wished.
Medistri SA guarantees a protocol of validation, measures and quality in compliance with the standard ISO 11135-1&2.
Medistri can perform all the necessary tests to develop new cycles and a validation of the process corresponding to your requirements.