Those responsible for packaging solutions for sterile medical products require a great deal of imagination and perception concerning the risks to which packaging is exposed from commencement of production through to the time of use. In the development of new products, it is therefore necessary that right from the start the aspects of packaging, sterilization, transport and storage are complied with.
But this not only apply for the area of medical technology. Those who think the cosmetics sector has nothing to do with sterility are wrong. National hygiene guidelines and regulations, for example, stipulate that "... reusable devices, instruments and items whose application generally involves injuring the skin or mucous membranes, e.g. needles for permanent make-up, must be subjected to hot-air or vapor sterilization after each use", whereby it goes without saying that this equipment must be sterile and in sterile packaging prior to first-time use. And a federal regulation also decrees: "When piercing and tattooing, exclusively sterile equipment, dyes and materials must be used with which no documented health risks are associated." And sterility is also indispensable in the case of wrinkle treatment with injected implants such as hyalutonan (restylane), liquid silicon or plastic beads.
Ethylene oxide (EtO), gamma irradiation or hot vapor in the autoclave are current sterilization methods. When applied as designated, each of these methods is regarded as both effective and safe.
Ethylene oxide sterilization is a low-temperature method which kills microorganisms at 10 °C by forming a compound with the protein molecules and destroying them. Combined with a low process temperature, this method is suitable for many thermoplastic materials and is applied in particular for disposable items.
Sterilization with hot vapor is at 121 or 134 °C and overpressure of up to three bar in the autoclave. When the vapor condenses on the item to be sterilized, energy is released which damages the microorganisms. Hot vapor sterilization at 134 °C is the most popular method of sterilizing reusable products.
High-energy, ionizing gamma irradiation deactivates the microorganisms. When this low-temperature method is applied, the minimum radiation dose must be observed. But not all plastics are suitable for multiple sterilization by gamma rays: this method is only applied industrially and almost exclusively for disposable items.
All of these methods can prevent biological contamination. But they each have advantages and disadvantages and above all significant effects on the material used. In order to prevent any negative impacts, the material formulae need to be compiled very carefully using stabilizers and other supporting ingredients – as is the case with the ProvaMed® portfolio offered by Actega DS. Extensive tests of the various variants comparing gamma irradiation, autoclaving and gassing with ethylene oxide indicate the resistance displayed by these materials to signs of wear such as swift ageing, brittleness, discoloration or changes in mechanical properties possible in the case of high-energy gamma irradiation, for example, while hot-vapor sterilization can cause shrinkage, deformation or even melting of the plastic.
The market for sterilization equipment for cosmetic, pedicure, tattoo, piercing and nail studios, and hairdressing salons is growing. One prerequisite is that the device to be sterilized is manufactured from a material which allows this type of sterilization without causing any signs of wear. Cosmetic devices and packaging manufactured from the ProvaMed® TPE help to prevent the negative effects associated with sterilization.
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