The regime

The scheduled process

Updated October 2026

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The definition So there are two steps It is specific to the product and the container Which means a container change reopens it Critical factors are named in the regulation Initial temperature is one of them And the process gets filed References

The process is not yours to choose, and the regulation says who establishes it.

The definition

Scheduled process means the process selected by the processor as adequate under the conditions of manufacture for a given product to achieve commercial sterility, and it shall be at least equivalent to the process established by a competent processing authority to achieve commercial sterility.

So there are two steps

A competent processing authority establishes a process for your product in your container at your fill. Then you select a process that equals or exceeds it. You can be more conservative and you cannot be less.

It is specific to the product and the container

Heat penetration depends on the food, its viscosity, its particulates, the container size and shape and the fill weight. A process established for a 500 mL jar of a thin broth is not a process for a 946 mL jar of a thick chunky soup.

Which means a container change reopens it

Changing jar size, jar shape, headspace or fill weight changes the heat penetration and therefore the process. That is the most consequential link between this library and this regime.

Critical factors are named in the regulation

A critical factor is any property, characteristic, condition, aspect or other parameter, variation of which may affect the scheduled process and the attainment of commercial sterility. Those get identified and then controlled.

Initial temperature is one of them

Defined as the average temperature of the contents of the coldest container to be processed at the time the thermal processing cycle begins, determined after thorough stirring or shaking of the filled and sealed container. That level of specificity is the norm here.

And the process gets filed

Alongside the establishment registration. The regime is built on the agency knowing who is doing this, where, with what equipment, and to what process.

References

21 CFR 113.3, the definitions for thermally processed low-acid foods packaged in hermetically sealed containers. Paragraph (j) defines a hermetically sealed container as one designed and intended to be secure against the entry of microorganisms so as to maintain commercial sterility; (n) defines low-acid foods as those with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products below pH 4.7; (r) requires a scheduled process at least equivalent to one established by a competent processing authority. law.cornell.edu

21 CFR 108.35, Thermal processing of low-acid foods packaged in hermetically sealed containers. Paragraph (a) records that the harmful nature of such foods cannot be adequately determined after they have entered interstate commerce; (c)(1) requires a commercial processor to register with FDA on Form FDA 2541 not later than 10 days after first engaging in such processing, giving the establishment locations, the processing method in terms of equipment employed, and a list of the low-acid foods processed. law.cornell.edu

21 CFR part 113 generally, which sets the equipment and procedural requirements for thermal processing systems, including instrumentation, venting, temperature and pressure records and operator supervision for each type of retort. law.cornell.edu

Written from federal regulation, not from a production kitchen. Nothing here is a scheduled process, and nothing here is a substitute for a competent processing authority. If you are considering a shelf-stable low-acid product, the first call is to a process authority rather than to a packaging supplier.