Due to the demands for increasing competitiveness and added value, as well as business success, educated and trained employees represent an increasing capital of companies. This is why at TIK d.o.o. we make sure that our employees are always aware of the latest guidelines in the field.
Various types of sterilization for medical devices have been outlined: EO, E-beam, Gamma, X-ray, according to the standards ISO 11135, ISO 11137, ISO 11138 and others, which are directly associated with sterilization and deal with procedures from validation to routine sterilization, packaging and proof of sterility.
The purpose of sterilization is to perform a procedure that is validated and controlled and provides material without the presence of living microorganisms for use with patients when the said material comes into contact with sterile areas of the body or the bloodstream. The aim of sterilization is to prevent transmission through infected instruments, equipment or reusable devices. The procedures and apparatus used must have appropriate characteristics to ensure action against microorganisms, and all the phases of the procedure must be specified and regularly monitored.
The cleanliness of the product itself is very important before the sterilization process, thus we have emphasized the importance of proper cleanroom production procedures according to the standards ISO 14644 and ISO 14698 and the importance of determining initial contamination according to the standard ISO 11737. Products must also be dried and properly packaged.
The relevance of the product after sterilization is also crucial, of course, as determined by many tests: determination of the endotoxin concentration (LAL test), the biocompatibility of the main and auxiliary materials, residual EO … The clinical evaluation of individual products is also crucial, where positive user feedback and criticism based on experience are very important.
