13. Sterilization of Biomaterials

Sterilization is a necessary and an important part of the manufacture of any biomaterial because infection is the last thing a patient who has undergone an implant placement surgery needs. This would hamper the healing process, probably make the implant unsuccessful and make the patient incapable of dealing with this additional health problem, while the actual surgery might have been a very serious one such as a cardiovascular implantation. Sterilization is needed because the implants could be carrying harmful microorganisms due the implant production environment being not sufficiently sterile, the operating theater may not be microorganism-free, or the surgical instruments could be contaminated. The solution for the last problem is proper sterilization of the implant. Of course in the operating room, all the instruments used during the operation should also be sterilized. The selection of an appropriate sterilization method is an important issue. The goal of sterilization is to reduce the amount of microorganisms found in the surgical environment and on the devices to an internationally acceptable level. However, the methods used to achieve this could have a significant effect on the physical, chemical, and toxicological properties of a biomaterial and as a result on its performance; therefore care should be exercised in the selection of the correct method of sterilization.