ABSTRACT
This chapter reviews some of the microbiological and physico-chemical assays used in quality control. It summarizes the basic microbiological procedures that can be used to ensure sterility or the absence of pathogens in devices and drugs as well as a minimal number of regulatory and compendial assays used to determine the toxic effects of devices. A safety program for biomaterials is fundamentally different from one for drugs. For devices, testing usually involves biologically inert materials that are independent of body metabolism for their effectiveness. The elution techniques used in the device industry to determine the microbial population on a presterilized device are outlined on new International Organization for Standardization (ISO) draft standard. Contact allergy or sensitization is also a part of the Tripartite and ISO recommendations, and Acute toxicity tests as the Maguire split-adjuvant, modified split-adjuvant, Kligman-Magnesson, Draize and Buehler tests are cited.
