Wednesday, 4 October 2017

Matrix Approach for the Qualification of a Pharmaceutical Facility Autoclave

The validation and verification of the sterilization process requires careful planning, and this includes selection of the loads (pre-defined configurations of items to be sterilized). For the validation or qualification approach different strategies can be adopted. One such approach, which avoids the qualification of every load, is to adopt a matrix design (bracketing) approach where ‘worst case’ combinations for all of the intended loads can be selected. The matrix approach uses a philosophy which allows for the testing of a subset of the intended autoclave loads to validate the entire range of load, in lieu of testing each loads in the matrix. With this paper the focus is on non-liquid loads, although reference is made to alternative approaches than can be considered for liquid autoclave loads. 

This is an extract from a new article by Tim Sandle for the Journal of GxP Compliance (a special edition devoted to Microbiology).

The reference is:

Sandle, T. (2017) Matrix Approach for the Qualification of a Pharmaceutical Facility Autoclave, Journal of GxP Compliance, 21 (4): 1- 10:

For further details, please contact Tim Sandle.

Posted by Dr. Tim Sandle

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