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Guide to Inspections of Low Acid Canned Food 49

Manufacturers - 2

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The following list has been compiled in an effort to obtain the minimum information necessary to make a valid assessment of a processors operations. EIR’s should include but not be limited to, all applicable items.

  1. Product Preparation, Filling and Closing Operations
    1. Product Formulation and Specifications
      1. Products packed, ingredients, styles of pack, packing medium (covering liquid).
      2. Product specifications; e.g. formulation, consistency, particle size, pH, etc..
    2. Product preparation.
      1. Blanching equipment and conditions (i.e., time and temperature) and control thereof.
      2. Preparation and holding kettles and tanks; times and temperatures and controls.
      3. Preparation of packing medium.
    3. Containers - Source, type and size(s) used.
    4. Filling
      1. Method (e.g. hand fill, mechanical with vibrating or shaking actions, etc.) and equipment, including manufacturer.
      2. Controls and records of fill weight, net weight, drained weight.
      3. Packing medium; filling method and equipment, temperature and control of.
      4. Headspace control (e.g. mechanical, volume, weight etc).
    5. Development of vacuum
      1. Exhausting of container (e.g. steam exhaust box, hot fill, steam injection, mechanical vacuum chamber etc.).
      2. Mechanical vacuum readings if critical to the thermal process.
    6. Closing Operations
      1. Closing machine model and make.
      2. Closure examinations; specifications, frequency and recording of visual and tear-down examinations.
      3. Qualifications and training of persons performing container examinations. Operating under the supervision of an individual who has attended a school of instruction as per 21 CFR 113.10.
      4. Coding method and information.
  2. Thermal Processing Schedules, Operations and Equipment
    1. Scheduled Processes
      1. Scheduled processes including critical factors of each product in each container size covered during the inspection.
      2. Source and date of processes.
      3. Scheduled venting procedures for steam retorts.
      4. Scheduled come-up procedures for water immersion cascading water and steam-air retorts.
      5. Procedures for handling process deviations.
    2. Operations
      1. Scheduled processes and operating procedures (e.g venting, come-up) posted or on file.
      2. Use of heat sensitive indicators and retort traffic control.
      3. Initial temperature, method and frequency of measurement.
      4. Type and accuracy of process timing devices.
      5. Operating under the supervision of a person who has attended a school of instruction as per 21 CFR 113.10.
      6. Actual venting or come-up procedures used.
      7. Actual retort operations, time(s), and temperature(s).
      8. Actual cooling practices.
    3. Equipment and Procedures
      1. Type, size and number of retorts.
      2. Mercury-in-glass (MIG) Thermometer specifications, date of accuracy checks, accuracy at time of check, standard used, method used to check accuracy.
      3. Temperature recording device(s); specifications of chart, installation, accuracy of timing mechanism, agreement with MIG thermometer.
      4. Retort temperature and pressure controllers; type (e.g. mechanical, air operated, computer controlled etc.) description of operation.
      5. Pressure gauges and pressure relief valve; specifications, installation and location if applicable.
      6. Steam entry, description of steam spreaders, steam injectors, heat exchangers etc..
      7. Retort crates, divider plates, container orientation, etc. complies with regulations and filed scheduled process requirements.
      8. Steam supply, boiler size and type, steam pressure at boiler, steam pressure at header, size of supply headers and pipes, length of pipes and headers.
        1. Still steam retorts
          1. Crate supports, vertical retorts.
          2. Bleeders; specifications, location, installation and use.
          3. Vents on steam retorts; type, location, installation and operation. If vents differ from specification in the regulations or if divider plates are used, evidence of adequacy is required.
        2. Still water immersion retorts
          1. Crate supports and guides in vertical retorts.

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