§113.100 杀菌过程和生产记录(Processing and production records)

　　§ 113.100   Processing and production records.

　　Link to an amendment published at 76 FR 11923, Mar. 3, 2011.修订杀菌过程和生产记录（Processing and production records）

　　（a） Processing and production information shall be entered at the time it is observed by the retort or processing system operator, or other designated person, on forms that include the product, the code number, the date, the retort or processing system number, the size of container, the approximate number of containers per coding interval, the initial temperature, the actual processing time, the mercury-in-glass and recording thermometer readings, and other appropriate processing data. Closing machine vacuum in vacuum-packed products, maximum fill-in or drained weight, or other critical factors specified in the scheduled process shall also be recorded. In addition, the following records shall be maintained:

　　（1） Still retorts. Time steam on; time temperature up to processing temperature; time steam off; venting time and temperature to which vented.

　　（2） Agitating retorts. Functioning of condensate bleeder; retort speed; and, when specified in the scheduled process, headspace, consistency, maximum drained weight, minimum net weight, and percent solids.

　　（3） Hydrostatic retorts. The temperature in the steam chamber between the steam-water interface and the lowest container position; speed of the container conveyor chain; and, when the scheduled process specifies maintenance of particular temperatures in the hydrostatic water legs, the temperatures near the top and the bottom of each hydrostatic water leg.

　　（4） Aseptic processing and packaging systems. Product temperature in the holding tube outlet as indicated by the temperature-indicating device and the temperature recorder; product temperature in the final heater outlet as indicated by the temperature recorder-controller; differential pressure as indicated by the differential pressure recorder-controller, if a product-to-product regenerator is used; product flow rate, as determined by the metering pump or by filling and closing rates; sterilization media flow rate or temperature or both; retention time of containers, and closures when applicable, in the sterilizing environment; and, when a batch system is used for container and/or closure sterilization, sterilization cycle times and temperatures.

　　（5） Flame sterilizers. Container conveyor speed; surface temperature at the beginning and at the end of the holding period; nature of container.

　　（6） Food preservation methods wherein critical factors such as water activity are used in conjunction with thermal processing. Product formulation and scheduled processes used, including the thermal process, its associated critical factors, as well as other critical factors, and results of awdeterminations.

　　（7） Other systems. Critical factors specified in the formulation of the product or in the scheduled process.

　　（b） Recording thermometer charts shall be identified by date, retort number, and other data as necessary, so they can be correlated with the written record of lots processed. Each entry on the processing and production records shall be made by the retort or processing system operator, or other designated person, at the time the specific retort or processing system condition or operation occurs, and this retort or processing system operator or other designated person shall sign or initial each record form. Not later that 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified by suitable training or experience shall review all processing and production records for completeness and to ensure that the product received the scheduled process. The records, including the recording thermometer chart（s）, shall be signed or initialed and dated by the reviewer.

　　（c） Written records of all container closure examinations shall specify the product code, the date and time of container closure inspections, the measurements obtained, and all corrective actions taken. Records shall be signed or initialed by the container closure inspector and reviewed by management with sufficient frequency to ensure that the containers are hermetically sealed.

　　（d） Records shall be maintained to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use.

　　（e） Copies of all records provided for in this part, except those required under §113.83 establishing scheduled processes, shall be retained at the processing plant for a period of not less than 1 year from the date of manufacture, and at the processing plant or other reasonably accessible location for an additional 2 years. If, during the first year of the 3-year record-retention period, the processing plant is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack.

　　更多关于美国FDA酸化食品HACCP法规，请详见美国FDA酸化食品HACCP法规第113和114部分汇总