Monday 4 July 2022

Annex 1 and sterilization process: an interview with Tim Sandle


The revision of Annex 1 is requiring a major effort from the life sciences industry; from ‘setting up new processes, to training staff, to managing noncompliance, the industry needs to adapt particularly to new requirements regarding contamination control strategy and the essential elements needed to develop a robust sterility assurance system.


One of the most discussed processes involves autoclaving and the risks associated with it.


We talked about it with Tim Sandle, a microbiologist, author and science journalist, known as one of the leading experts in the field.


The interview has been conducted by AM Instruments.


See: (English) or (Italian)


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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