Studies have shown that the processing time necessary to achieve decontamination of biological material depends on several factors: load size, type of container, and moisture content.
If the waste is packed too tightly or it is a very large load, the length of the sterilization time may need to be increased to allow the steam to penetrate the center of the load.
The emphasis is on the calibration of instruments because small errors in temperature can affect the Fo value to a great extent.
A robust deviation management process should exist as they may impact the quality of the product.
Good handling of deviations help us to improve our qualification, though they are often viewed negatively and not as a mechanism for process improvement.
This can be avoided by item photographing and releasing the same patterns in the protocol and work instructions.
This will avoid the arbitrary interpretation of descriptive configuration.