Achieving sterility is the highest priority for medical products. It requires serious attention and effort in the development process of the sterilized medical products. Development in technology such as advances in semiconductor and packaging technologies has lead to integrated circuits (ICs) found in a range of equipment including medical devices. Keeping medical products free from harmful contaminants like bacteria, fungi, viruses, and spore forms is a big challenge. Proactive and purposive efforts applied to sterilization can lead to improved outcomes.
There are many physical and chemical methods of sterilization which are combined to get better results. The most efficient physical methods combine heat with humidity and pressure in a device called an autoclave which is similar to a pressure cooker. Autoclave sterilization is the method that has been into existence since ancient times in which the presence of moisture significantly speeds up heat penetration. But this method is suites only objects such as surgical instruments that can tolerate humidity, high temperature from +121°C to +148°C and high pressure from 1 to 3.5 atmospheres above ambient.
The other popular methods Gamma sterilization, E-beam sterilization, Ethylene Oxide (EtO) sterilization, and X-ray sterilization are used and tested depending on the specific need of the product. It is almost impossible to select a sterilization option which is without effect completely, as many materials are used to make modern medical products. For instance, steam can send moisture deep into materials that have long-term effects; radiation produces ozone and other end products which can affect functionality; ethylene oxide leaves behind traces of itself and reaction products. But with proper process selection and optimization, these effects are managed by identifying and monitoring them.
Packaging is the most crucial part of the product and should be scrutinized equally. Package density is vital for efficiency and dose uniformity of irradiated products with gamma, x-ray, and e-beam, each having distinct optimal configurations. In the same way, ethylene oxide needs breathable packages with ideally sufficient porosity that they are not the limiting factor to sterilant diffusion. Knowledge about the sterilization process development is a powerful tool that organizations can posses these days for the manufacturing of medical products. This knowledge can help in the innovations of new products and methods that are effective, safe, and commercially successful.