Monday, 21 May 2018

Risk considerations for the installation of a new pharmaceutical facility autoclave


Tim Sandle has written an article for the website sterilize.it, the article covers:

This article considers some of the risk considerations that need to be accounted for when replacing a steam sterilization autoclave within a pharmaceutical processing facility. In outlining the key risk considerations, the article adopts a risk assessment approach – Failure Modes and Effects Analysis (FMEA).

Risk management and risk assessment principles should be applied as early as possible during the design and construction of steam sterilization devices. With steam sterilization devices the most critical functions are, arguably, the steam sterilization of direct and indirect the product contact parts. A second important aspect relates to air removal. All of the trapped air must be removed from the autoclave before activation. This is because trapped air is a very poor medium for achieving sterility.

The reference is:

Sandle, T. (2018) Risk considerations for the installation of a new pharmaceutical facility autoclave, Sterilize.IT at: https://www.sterilize.it/process/risk-considerations-for-the-installation-of-a-new-pharmaceutical-facility-autoclave/

Posted by Dr. Tim Sandle

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