Pressure-Assisted Sterilization Accepted by FDA

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The FDA on Feb. 27 accepted a petition for the commercial use of pressure-assisted thermal sterilization (PATS) processes for low-acid foods. The process combines mild heat with high pressure to produce commercially sterile food products.

The acceptance was the culmination of seven years and millions of dollars of research. The petition was filed by the National Center for Food Safety and Technology (NCFST), in Summit-Argo, Ill., along with Illinois Institute of Technology (IIT) and Avure Technologies Inc.

NCFST officials said the effort included scientists and engineers from Basic American Foods, Baxter Health Care, ConAgra Foods, General Mills, Hormel Foods, Mars Inc. and Unilever, as well as the U.S. Army Natick Soldier Research, Development and Engineering Center.

NCFST said the process improves the quality of thermally processed foods while simultaneously eliminating the food safety risks associated with dangerous bacteria such as Clostridium botulinum and its toxins. The process underwent a rigorous validation process and safety assessment by NCFST.

“The threat of botulism makes low-acid food production especially challenging for food manufacturers,” says Larry Keener, president of process authority International Product Safety Consultants. “With this FDA filing, NCFST and its industry collaborators have demonstrated proof of process efficacy for this exciting new technology.”

The process essentially combines high pressure processing (HPP), which has been used successfully for several years to pasteurize a number of refrigerated foods (notably avocado, juice and some deli meats) with mild heat to achieve sterilization temperature. It provides an alternative to retort processing, which involves extensive exposure of the food to high temperatures.

Avure has been a leader in HPP technology and a manufacturer of the high-pressure vessels needed for the process.

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