Sterilization packaging with appropriate materials and sterility assurance level

Abstract

all disinfected materials should be packed with appropriate materials to ensure
sterilization safety. The most important step of the sterilization cycle is considered to be
packaging. The function of sterile material packaging is to prevent the deterioration of
the sterilization integrity of the material by creating a defense against unwanted
microorganisms and viruses after sterilization. There are many packaging materials with
different properties produced for this purpose. ISO, Standards Institution attaches
importance to the packaging of medical devices at an international level. ISO 11607-1
Part-1,-2 standardizes the technical standards that must be followed in medical device
packaging. This standard is a guide that is valid in all areas where medical devices are
packaged, especially in hospitals. For the sterilization of steam, ethylene oxide,
formaldehyde, and hydrogen peroxide gas plasma sterilization methods, sterilization
bags, transparent multi-layer copolymer PET/PP film, and medical paper combinations
are used. Liquid and steam and C2H4O EO processing indicators by the ISO 11140-1
standard are applied to the paper surface, and these indicators distinguish between
treated and untreated packages. Advantages of Sterilization Packaging materials can be
summarized as Product protection, Microbial barrier, Physical protection from damage,
Compatibility with the sterilization method, Maintenance of sterility and integrity until
use, Easy opening, and aseptic presentation, Identification of the Product (printing,
labeling). As a result, the probability of a single viable microorganism remaining at the
end of the selected sterilization process should be ≤10-6.