Thermal processing.

CFR · 2024-01-01 · US · Title 9

(a) (b) (2) Any change in product formulation, ingredients, or treatments that are not already incorporated in a process schedule and that may adversely affect either the product heat penetration profile or sterilization value requirements must be evaluated by the establishment's processing authority. If it is determined that any such change adversely affects the adequacy of the process schedule, the processing authority must amend the process schedule accordingly. (3) Complete records concerning all aspects of the development or determination of a process schedule, including any associated incubation tests, must be made available by the establishment to the Program employee upon request. (c) (2) Letters or other written communications from a processing authority recommending all process schedules must be maintained on file by the establishment. Upon request by Program employees, the establishment must make available such letters or written communications (or copies thereof). If critical factors are identified in the process schedule, the establishment must provide the inspector with a copy of the procedures for measuring, controlling, and recording these factors, along with the frequency of such measurements, to ensure that the critical factors remain within the limits used to establish the process schedule. Once submitted, the process schedules and associated critical factors and the procedures for measuring (including the frequency), controlling, and recording of critical

official document · source cfr-2024 · id 9:§ 431.3