Monday, 20 July 2015

Aseptic Transfer Risk Assessment: A Case Study

Aseptic transfer is a key operation in relation to sterile products. In a new paper, a risk assessment approach is presented. Here is the abstract:

“This paper uses one example of a risk assessment approach to illustrate how risk assessment can be incorporated into good manufacturing controls. The specific activity assessed involves transferring a set of sterilised stoppers from an autoclave to a filling machine within a sterile manufacturing facility. The risk assessment approach adopted is a form of HACCP (Hazard Analysis Critical Control Points).”

The reference is:

Sandle, T. (2015): Aseptic Transfer Risk Assessment: A Case Study, Journal of Validation Technology, 21(1): 1-10 Online:

Posted by Tim Sandle