HyClone developed a raw material risk assessment tool2 based on geographic origin, animal donor, animal husbandry, material harvest, post harvest handling, final preparation, and material use. Both raw material risk (Figure 1) and recipient risk (Figure 2) are considered. It is designed as a discussion tool to direct inhouse raw material reviews. The numbers ascribed in the Response Range column may be changed based on your estimate of relative risk. In fact, the higher the number, the greater the risk. Entire responses may be eliminated due to unacceptably high risk. A total score of less than 40, in this example, is considered minimal risk requiring no additional pre-use processing beyond sterile filtration. Risk is moderate if the score is 40 to 100. If a careful review of the assessment does not lead to a lower total score by changing vendors, geographic origins, animal species, etc., additional preuse processing should be considered. A total score greater than 100 indicates high risk and additional pre-use processing beyond sterile filtrations is required.