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: http://www.ivtnetwork.com/article/aseptic-transfer-risk-assessment-case-study
Posted by Tim Sandle
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