Packaging gamma sterilization

Packaging for sterile products must be effectively contained and sealed to prevent microbial contamination, and must be robust enough to withstand any sterilisation process required. The sterilisation process can affect the leaching of components from the container into the product or affect the physical properties of the container. For example, autoclaving can soften plastic containers, and gamma irradiation can cause certain polymers to cross link. 

An example of historical air-permeable packaging used with gamma sterilization, consisting of a box, two nested, polymeric packages, and an inner foam insert (Osteonics, Allendale, NJ). The UHMWPE component is not shown. 

Historical air-permeable packaging used with gamma sterilization (Wright Medical, Arlington, TN). 

Summary of Contemporary Barrier Packaging Techniques Used for Gamma Sterilization of UHMWPE Among Major Orthopedic Manufacturers (as of January 2003)... 

Contemporary nitrogen-filled barrier packaging for gamma sterilization of UHMWPE components used by Zimmer, inc. (Warsaw, iN). 

Contemporary packaging for gamma sterilization of Enduron conventional UHMWPE components, used by DePuy Orthopedics (Warsaw, IN). 

Collagenous devices can be sterilized by filtration, exposure to c otoxic chemicals, gamma irradiation or treatment with an electron beam. Injectable collagen is typically sterilized by sterile filtration which requires final packaging tinder sterile conditions. Zyplast and Zyderm injectable collagen implant materials are processed in this manner. 

During the 1990s, the packaging and sterilization of UHMWPE was a controversial topic. As recently as 1995, UHMWPE was typically sterilized with a nominal dose of 25 to 40kGy of gamma radiation in the presence of air. By 1998, all of the major orthopedic manufacturers in the United States were either sterilizing UHMWPE using... 

---