What should i do when i have a temperature over shoot during the annual Autoclave re- qualification cycle? And what is the impact of that overshoot on the cycle , the qualification activity and the load?
what degree of warming are we talking about?
A deviation should be issued to:
- Determine the extension of product that could have been impacted
- Determine the impact on product quality
- Identify root cause of overshoot
- Establish Corrective and preventive actions
Please, take into account product stability and integrity of the container-closure system. It is expected that you put samples of that load for long term stability, to be sure of the impact on product stability. Health authorities expect robust and sound evidence that product stability is not affected if the product is to be released.