Monday 27 July 2015

Risk assessment for a new autoclave project

The installation of pharmaceutical equipment needs to embrace quality by design. Part of the design process should embrace risk assessment. In a new paper, the risk assessment for the installation of a new autoclave is mapped out. Here is the abstract:

“This paper addresses some of the risk considerations that must be evaluated when replacing a steam sterilizing autoclave within a pharmaceutical processing facility.  It demonstrates the application of Failure Modes and Effects Analysis (FMEA) for assessment of risk as part of quality risk management. Tables for classifying these aspects are provided.”

The reference is:

Sandle, T. (2015):  Risk Considerations for Installation of a New Autoclave in a Pharmaceutical Manufacturing Facility, Journal of Validation Technology, 21(1): 1-10 Online:

Posted by Tim Sandle

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