Chapter 15 - Low-Acid and Acidified Low-Acid Foods in Hermetically Sealed Containers (Canned Foods)
15.5 Quality Assurance

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It is important that scheduled processes be properly established, correctly applied, sufficiently supervised and documented to provide positive assurance that the requirements have been met. These assurances apply also to the seaming and sealing operations. For practical and statistical reasons, an end-product analysis by itself is not sufficient to monitor the adequacy of the scheduled process.

15.5.1 Processing and Production Records

Permanent, legible and dated records of time, temperature, codes and other pertinent details shall be kept concerning each retort load or code lot for continuous retorts or aseptic processes. Such records are essential as a check on processing operations and will be invaluable if some question arises as to whether a particular lot had received adequate heat processing. These records shall be made by the retort or processing system operator or other designated person, on forms which shall include: product name and style, the code lot number, the retort or processing system and recorder chart identification, the container size and types, the approximate number of containers per code lot interval, the minimum initial temperature, the scheduled and actual processing time and temperature, the recorder-controller and indicating thermometer readings, and other appropriate processing data. Closing vacuum (in vacuum-packed products), fill-in weights, filled flexible pouch thickness, and/or other critical factors specified in the scheduled process shall also be recorded. When deviations occur in the application of the scheduled process refer to sub-section 4.6 of this Code. In addition, the following records shall be maintained:

15.5.1.1 Processing in Steam

15.5.1.1.1 Static Autoclaves

  • time steam on;
  • venting time and temperature;
  • time sterilization temperature reached; and
  • time steam off.

15.5.1.1.2 Batch Agitating Retorts

As for still retorts (see 15.5.1.2.1) with additions of functioning of condensate bleeder as well as retort and/or reel speed. Where specified in the scheduled process it is important to also record container head space and critical factors such as in-going product consistency and/or viscosity, maximum drained weight, minimum net weight and per cent solids (see 15.4.4.2).

15.5.1.1.3 Continuous Agitating Retorts (See 15.5.1.1.2)

15.5.1.1.4 Hydrostatic Retorts

The temperature in the steam chamber should be at just above the steam-water interface, at the top of the dome, if applicable, speed of the container conveyor, and, where the scheduled process specifies, measurements of particular temperatures and water levels in the hydrostatic water legs.

In addition, for agitating hydrostatic retorts, rotative chain speed, and other critical factors such as the head space and in-going product consistency.

15.5.1.2 Processing in Water

15.5.1.2.1 Static Autoclaves

  • time steam on;
  • come-up time;
  • time sterilization starts;
  • sterilization temperature;
  • water level;
  • water circulation and pressure maintained; and
  • time steam off.

15.5.1.2.2 Batch Agitating Retorts

As for still retorts (Sub-Section 15.5.1.2.1) with the addition of retort and/or reel speed. Where specified in the scheduled process it is important to record container head space and critical factors such as in-going product consistency, maximum drained weight, minimum net weight and per cent solids (see 15.4.4.2).

15.5.1.3 Processing in Steam/Air Mixtures

15.5.1.3.1 Static Autoclaves

  • time steam on;
  • come-up time;
  • time sterilization starts;
  • maintenance of circulation of steam/air mixture;
  • pressure;
  • sterilization temperature; and
  • time steam off.

15.5.1.4 Aseptic Processing and Packaging

Detailed automatic and manual record requirements depend on the type of aseptic processing and packaging system, but they must provide complete and accurate documentation of the pre-sterilization and running conditions actually used.

15.5.1.4.1 Product Container Sterilization Conditions

Record sterilization media flow rate and/or temperature, where applicable, retention time in the sterilizing equipment of containers and closures. Where a batch system is used for container and/or closure sterilization, sterilization cycle times and temperatures should be recorded.

15.5.1.4.2 Product Line Conditions (see 15.4.5.6)

Record pre-sterilization of the product line, "stand-by" and/or "change-to-product", as well as running conditions. Running condition records should include product temperature at the final heater outlet, product temperature at holding section outlet, differential pressures if a product-to-product regenerator is used, and the product flow rate.

15.5.1.5 Flame Sterilizers

  • container conveyor speed;
  • can surface temperature at the end of the process holding period; and
  • nature of container.

15.5.2 Record Review and Maintenance

15.5.2.1 Processing Records

Recorder charts shall be identified by date, product, container size, retort and where applicable the cooker shell number and other data as necessary volume of production, so they can be correlated with the written record of lots processed. Each entry on the record 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 the retort or processing system operator or such designated person shall sign or initial each record form. Prior to shipment or release for distribution, but not later than one working day after the actual process, a representative of plant management who is knowledgeable and experienced in canning technology shall review and ensure that all processing and production records are complete and that product received the scheduled process. The records, including the recorder thermometer chart, shall be signed or initialled by the person conducting the review.

15.5.2.2 Container Closure Records

Written records of all container closure examinations shall specify the code lot, the date and time of container closure inspections, the measurements obtained, and all corrective actions taken. Records shall be signed or initialled by the container closure inspector and shall be reviewed by a representative of plant management who is knowledgeable and experienced in canning technology with sufficient frequency to ensure that the records are complete and that the operation has been properly controlled.

15.5.2.3 Water Quality Records

Records shall be kept of the results of all tests of microbiological quality and cooling water treatment records shall be retained for at least three years.

15.5.3 Retention of Records

The records specified in Sub-Sections 15.4.4, 15.4.7, 15.5.1 and 15.5.2 shall be retained for a period of not less than three years to assist investigation of problems. They shall be held in a manner which will permit ready reference by the processor. The statement of a scheduled process shall be retained for at least three years after its discontinuation of its use.

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