Retort Validation (TD and HP Studies) should Not to be done for the Sake of Doing it. It should be done perfectly and precisely using internationally approved and accepted validation equipment in compliance with FDA 21 CFR Part 11 (to avoid data tampering / manipulation), with highly reliable and accurate sensors with proper heat penetration fittings and fixtures.

This is because the Heat Penetration Study in conjunction with the corresponding TD study is the Heart of the Retort Processing of any products. The retort validation studies decide the Safety and Quality of the Retort Food products, because regular commercial production fully depends on the control parameters derived from the validation studies. So processors SHOULD NOT adjust, bypass or compromise the critical parameters involved in the retort validation activities.

A systematic or experimental error of 1 deg C in a temperature measurement system at the sterilization reference temperature of 121.1 deg C, would lead to a corresponding error of 26% in the calculated Fo Sterility Value, resulting either under-sterilization or overcooking of the products.