+-----------------------------------------------------------------------+
| DEPARTMENT OF HEALTH AND HUMAN SERVICES                               |
|                                                                       |
| FOOD AND DRUG ADMINISTRATION                                          |
|                                                                       |
| **PROCESSING IN STEAM-AIR RETORTS**                                   |
|                                                                       |
| **(Retort Survey)**                                                   |
+-----------------------------------------------------------------------+
| > **INSTRUCTIONS**                                                    |
| >                                                                     |
| > Complete the question blocks below. Narrative responses to each     |
| > item can be entered in the item's "comments" area or\               |
| > where otherwise prompted. Draw a diagram of the retort or obtain    |
| > one from the firm. Attach the diagram as an exhibit to the\         |
| > EIR. Report all pipe sizes as inside diameter (ID). Cross-sectional |
| > area = 3.14r2 (r = ½ diameter).                                     |
| >                                                                     |
| > If problems are found with the firm's retort equipment or           |
| > processing system, refer the reader to the narrative Turbo\         |
| > EIR under "Objectionable Conditions and Management's Response," and |
| > include a narrative explanation of specific\                        |
| > problems and evidence under the subheading "Supporting Evidence and |
| > Relevance." Submit the completed form as\                           |
| > an EIR attachment.                                                  |
| >                                                                     |
| > Steam-air retorts are covered by 113.40(j) -- "Other Systems" and   |
| > must meet the requirements found in applicable sections\            |
| > of 113.40. The retorts and operating procedures must be carefully   |
| > evaluated to insure that they comply with Part 113.                 |
| >                                                                     |
| > Some of the questions in this form are designed to capture          |
| > information useful in evaluation of the retort system and may not\  |
| > indicate a deviation from LACF Regulations, Part 113. The FDA       |
| > "Guide to Inspections of Low Acid Canned Foods, Part 2"             |
| >                                                                     |
| > should be used as a guide when conducting inspections of steam-air  |
| > retort systems.                                                     |
| >                                                                     |
| > Steam-air retorts are made by a variety of different manufacturers. |
| > They are normally horizontal batch type still or rotary\            |
| > end-over-end retorts. Steam-air has been used in some installations |
| > as the heating medium in continuous rotary, hydrostatic\            |
| > and hydrolock retorts. Photographs are an excellent means of        |
| > enhancing the description of a retort system.                       |
+-----------------------------------------------------------------------+

+----------------+--------------------+--------------+-----------------+
| **RETORT       |                    |              |                 |
| DESCRIPTION**  |                    |              |                 |
+----------------+--------------------+--------------+-----------------+
| RETORT NO.     | TYPE OF RETORT     | LENGTH OR    | DIAMETER        |
|                |                    | HEIGHT       |                 |
|                | Vertical           |              |                 |
|                | Horizontal         |              |                 |
|                |                    |              |                 |
|                | Other              |              |                 |
+----------------+--------------------+--------------+-----------------+
| > RETORT       |                    |              |                 |
| >              |                    |              |                 |
|  MANUFACTURER: |                    |              |                 |
| >              |                    |              |                 |
+----------------+--------------------+--------------+-----------------+
| > RETORT       |                    |              |                 |
| > MODEL:       |                    |              |                 |
+----------------+--------------------+--------------+-----------------+
| > TEMPERATURE  |                    |              |                 |
| > RANGE OF     |                    |              |                 |
| > THERMAL      |                    |              |                 |
| > PROCESS      |                    |              |                 |
| > (E.G.,       |                    |              |                 |
| > 245/250/260  |                    |              |                 |
| > DEGREE F):   |                    |              |                 |
| >              |                    |              |                 |
+----------------+--------------------+--------------+-----------------+
| > NUMBER OF    |                    |              |                 |
| > BASKETS OR   |                    |              |                 |
| > CRATES PER   |                    |              |                 |
| > RETORT:      |                    |              |                 |
| >              |                    |              |                 |
+----------------+--------------------+--------------+-----------------+
| > PROCESSING   |                    |              |                 |
| > MODE Static  |                    |              |                 |
| > Still        |                    |              |                 |
| > Agitating    |                    |              |                 |
| > End-over-End |                    |              |                 |
| > Axial        |                    |              |                 |
| > Rocking      |                    |              |                 |
+----------------+--------------------+--------------+-----------------+
| > ARE THERE    |                    |              |                 |
| > ANY          |                    |              |                 |
| > PROTRUSIONS  |                    |              |                 |
| > INSIDE THE   |                    |              |                 |
| > RETORT OR    |                    |              |                 |
| > THE RETORT   |                    |              |                 |
| > DOOR CASING  |                    |              |                 |
| > WHICH COULD  |                    |              |                 |
| > DAMAGE\      |                    |              |                 |
| > CONTAINERS   |                    |              |                 |
| > DURING       |                    |              |                 |
| > LOA          |                    |              |                 |
| DING/UNLOADING |                    |              |                 |
| > OF CRATES?   |                    |              |                 |
| > Yes No       |                    |              |                 |
| >              |                    |              |                 |
| > COMMENTS:\   |                    |              |                 |
| >              |                    |              |                 |
+----------------+--------------------+--------------+-----------------+

+-----------------------------------------------------------------------+
| **COMPUTER CONTROLS**                                                 |
+-----------------------------------------------------------------------+
| > DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? Yes No         |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM HAVE DOCUMENTATION ON HAND THAT INDICATES THAT THE    |
| > COMPUTER SYSTEM HAS BEEN VALIDATED?                                 |
| >                                                                     |
| > Yes No                                                              |
+-----------------------------------------------------------------------+
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? Yes No             |
| >                                                                     |
| > IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11? Yes No  |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **AGITATION**                                                       |
+-----------------------------------------------------------------------+
| > IS THE AGITATING RETORT OPERATED IN THE STILL MODE? Yes No          |
| >                                                                     |
| > COMMENTS:                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAVE PROCESS ESTABLISHMENT TESTS DETERMINED THAT RETORT CRATE       |
| > POSITION IS CRITICAL TO THE PROCESS OR\                             |
| > COME UP PROCEDURE? Yes No                                           |
| >                                                                     |
| > IF YES, DESCRIBE THE CRATE POSITION RECOMMENDED BY THE PROCESS      |
| > AUTHORITY:                                                          |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HOW DOES THE FIRM DETERMINE CRATE POSITION?                         |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WAS THE RECOMMENDED CRATE POSITION BEING USED DURING THE            |
| > INSPECTION? Yes No                                                  |
| >                                                                     |
| > COMMENTS:                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > EXPLAIN HOW THE RETORT ROTATION SPEED IS DETERMINED:                |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > EXPLAIN HOW THE RETORT ROTATION SPEED IS RECORDED:                  |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **STEAM-AIR MIXTURE**                                                 |
+-----------------------------------------------------------------------+
| > WHAT IS THE PROCESSING PRESSURE USED DURING THERMAL PROCESSING?     |
| > *(NOTE IF SEVERAL DIFFERENT\                                        |
| > PROCESSING TEMPERATURES ARE USED; PLEASE NOTE THE PRESSURE AT EACH  |
| > TEMPERATURE. IF THE FIRM\                                           |
| > PROCESSES DIFFERENT CONTAINER TYPES, PLEASE NOTE THE PRESSURE FOR   |
| > EACH CONTAINER TYPE.)*                                              |
| >                                                                     |
| > COMMENTS:                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHAT IS THE PERCENT STEAM/AIR MIXTURE USED DURING PROCESSING:       |
| >                                                                     |
| > *(NOTE: % STEAM CAN BE DETERMINED BY DIVIDING THE STEAM PRESSURE    |
| > POUNDS PER SQUARE INCH ACTUAL BY THE*                               |
| >                                                                     |
| > *TOTAL SYSTEM PRESSURE.)*                                           |
| >                                                                     |
| > E.g., 10 PSI (generated by temp of 240 degrees F) + 14.7 PSI        |
| > Atmospheric pressure = 24.7 = 83% steam                             |
| >                                                                     |
| > 15 PSI gauge reading on retort + 14.7 PSI Atmospheric pressure =    |
| > 29.7 (24.7/29.7 x 100 = 83%)                                        |
+-----------------------------------------------------------------------+
| > HOW IS STEAM ADDED TO THE RETORT? Steam Spreader Other              |
| >                                                                     |
| > IF OTHER, EXPLAIN:\                                                 |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE STEAM SPREADER OR OTHER SYSTEM IN A GOOD STATE OF REPAIR?    |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE THE LOCATION WHERE COMPRESSED AIR IS ADDED TO THE RETORT:\ |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE COMPRESSED AIR HEATED PRIOR TO BEING ADDED TO THE RETORT?    |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS A DIFFUSER USED ON THE AIR ENTRY TO INSURE MIXING OF THE AIR AND |
| > STEAM? Yes No                                                       |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAS THE AREA WHERE AIR ENTERS THE RETORT BEEN IDENTIFIED AS A COLD  |
| > SPOT IN THE RETORT? Yes No                                          |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HOW IS PRESSURE CONTROLLED IN THE RETORT?                           |
| >                                                                     |
| > Set Pressure Relief Valve Card Reader Computer Program Analog       |
| > Controls Other                                                      |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM HAVE DOCUMENTATION WHICH INDICATES THE PERCENT AIR OR |
| > AIR PRESSURE PARAMETERS CRITICAL                                    |
| >                                                                     |
| > TO THE THERMAL PROCESS? Yes No                                      |
| >                                                                     |
| > DESCRIBE THESE PARAMETERS:\                                         |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM MONITOR AND RECORD RETORT PRESSURE DURING PROCESSING? |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF A PRESSURE GAGE IS PRESENT, IS IT GRADUATED IN DIVISIONS OF 2    |
| > LBS. OR LESS? Yes No                                                |
| >                                                                     |
| > *(NOTE: STEAM AIR RETORTS SHOULD BE EQUIPPED WITH A PRESSURE GAUGE  |
| > TO INDICATE PROCESSING PRESSURE*                                    |
| >                                                                     |
| > *THAT CAN BE USED TO CALCU*                                         |
| >                                                                     |
| > *LATE THE RATIO OF STEAM TO AIR IN THE RETORT.)*                    |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DO THE PRESSURES NOTED MEET THOSE ESTABLISHED BY THE TEMPERATURE    |
| > DISTRIBUTION STUDIES?                                               |
| >                                                                     |
| > Yes No                                                              |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM HANDLE DEVIATIONS FROM PROCESSING PRESSURES AS        |
| > PROCESS DEVIATIONS? Yes No                                          |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHAT METHOD IS USED TO MIX THE STEAM AND AIR? Fan Bleeders Other    |
| >                                                                     |
| > DESCRIBE:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS WATER OR CONDENSATE ADDED TO THE STEAM AIR MIXTURE? Yes No       |
| >                                                                     |
| > EXPLAIN:                                                            |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HOW DOES THE FIRM INSURE THAT THE FAN IS OPERATING?                 |
| >                                                                     |
| > Indicator Light Computer Monitoring Visual Inspection               |
| >                                                                     |
| > DESCRIBE INSPECTION FREQUENCY:\                                     |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **MERCURY IN GLASS THERMOMETERS/TEMPERATURE INDICATING DEVICES**    |
+-----------------------------------------------------------------------+
| > IS THE RETORT EQUIPPED WITH A MIG THERMOMETER? Yes No               |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATOR   |
| > DEVICE? IF SO, DESCRIBE THE\                                        |
| > INDICATOR. Yes No                                                   |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE SCALE DIVISIONS EASILY READABLE TO 1°F (.5°C)? Yes No           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > NO. OF DEGREES F OR C/IN. OF GRADUATED SCALE: [     ]{.underline} . |
| > *(TEMP. RANGE MUST NOT EXCEED 17°F (8°C) PER\                       |
| > INCH (4°C PER CM) OF GRADUATED SCALE. SEE LACF GUIDE, P. 14.)*      |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DATE TEMPERATURE INDICATING DEVICE LAST TESTED FOR ACCURACY:        |
| > [     ]{.underline}                                                 |
| >                                                                     |
| > *(THERMOMETERS SHALL BE TESTED FOR ACCURACY AGAINST A KNOWN         |
| > ACCURATE STANDARD THERMOMETER UPON*                                 |
| >                                                                     |
| > *INSTALLATION AND AT LEAST ONCE A YEAR THEREAFTER; RECORDS OF       |
| > ACCURACY CHECKS THAT SPECIFY DATE,*                                 |
| >                                                                     |
| > *STANDARD USED, METHOD USED, AND PERSON PERFORMING THE TEST SHOULD  |
| > BE MAINTAINED. EACH THERMOMETER*                                    |
| >                                                                     |
| > *SHOULD HAVE A TAG, SEAL, OR OTHER MEANS OF IDENTITY THAT INCLUDES  |
| > THE DATE IT WAS LAST TESTED FOR*                                    |
| >                                                                     |
| > *ACCURACY -- 113.40(a)(1).)*                                        |
+-----------------------------------------------------------------------+
| > STANDARD USED FOR THE TEST:\                                        |
| >                                                                     |
+-----------------------------------------------------------------------+
| > NAME AND TITLE OF PERSON WHO PERFORMED TEST:\                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE LAST TEST DATE IDENTIFIED ON THE TEMPERATURE INDICATING      |
| > DEVICE? Yes No                                                      |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE THE FIRM'S ACTIONS REGARDING MIG THERMOMETERS/TEMPERATURE  |
| > INDICATORS THAT WERE OUT OF\                                        |
| > CALIBRATION:\                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE MIG THERMOMETER MERCURY UNDIVIDED? Yes No                    |
| >                                                                     |
| > *(A THERMOMETER THAT HAS A DIVIDED MERCURY COLUMN OR THAT CANNOT BE |
| > ADJUSTED TO THE STANDARD SHALL\                                     |
| > BE REPAIRED OR REPLACED -- 113.40(a)(1).)*                          |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WHEN TEMPERATURE INDICATING THERMOMETERS ARE FOUND TO BE PROVIDING  |
| > READINGS ABOVE THE ACTUAL\                                          |
| > TEMPERATURES, DOES THE FIRM EVALUATE PRODUCTS PRODUCED USING THOSE  |
| > THERMOMETERS? Yes No                                                |
| >                                                                     |
| > DESCRIBE THE FIRM'S PROCEDURES: *(NOTE IF THE ACTUAL TEMPERATURE IS |
| > BELOW THAT REQUIRED BY THE\                                         |
| > SCHEDULED THERMAL PROCESS, THIS WOULD BE A PROCESS DEVIATION AS PER |
| > 113.89.)\                                                           |
| > *                                                                   |
+-----------------------------------------------------------------------+
| IS THE TEMPERATURE INDICATING THERMOMETER LOCATED WHERE IT IS EASY TO |
| READ ACCURATELY?                                                      |
|                                                                       |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > THE SENSOR BULB IS LOCATED IN THE Retort Shell External Well        |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DIAMETER OF OPENING TO EXTERNAL WELL: [     ]{.underline}           |
+-----------------------------------------------------------------------+
| > HOW DOES THE FIRM INSURE THAT THE TEMPERATURE MEASURED IN THE WELL  |
| > IS REPRESENTATIVE OF THE\                                           |
| > TEMPERATURE IN THE RETORT SHELL?\                                   |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **TEMPERATURE RECORDER**                                            |
+-----------------------------------------------------------------------+
| > TYPE OF TEMPERATURE RECORDER Round Circular Chart Strip Chart Other |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE TEMPERATURE CHART ADJUSTED TO AGREE AS NEARLY AS POSSIBLE    |
| > WITH BUT NOT HIGHER THAN THE KNOWN\                                 |
| > ACCURATE MERCURY-IN-GLASS THERMOMETER DURING THE PROCESSING PERIOD? |
| > Yes No                                                              |
| >                                                                     |
| > *(**[SHALL]{.underline}** REQUIREMENT OF 113.40(b)(2))*             |
| >                                                                     |
| > NOTE ANY DIFFERENCE BETWEEN THE RECORDING THERMOMETER AND THE       |
| > MERCURY-IN-GLASS THERMOMETER AND                                    |
| >                                                                     |
| > WHICH READING IS HIGHER:\                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THERE A MEANS FOR PREVENTING UNAUTHORIZED ADJUSTMENTS? Yes No    |
| >                                                                     |
| > *(A MEANS OF PREVENTING UNAUTHORIZED CHANGES IN ADJUSTMENTS SHALL   |
| > BE PROVIDED. A LOCK OR NOTICE FROM\                                 |
| > MANAGEMENT STATING "ONLY AUTHORIZED PERSONS ARE PERMITTED TO MAKE   |
| > ADJUSTMENTS" & POSTED AT OR NEAR\                                   |
| > THE RECORDING DEVICE IS A SATISFACTORY MEANS FOR PREVENTING         |
| > UNAUTHORIZED CHANGES -- 113.40(b)(2).)*                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE CHART DRIVE TIMING MECHANISM ACCURATE? Yes No                |
| >                                                                     |
| > IF NO, EXPLAIN:\                                                    |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE RECORDER COMBINED WITH A STEAM CONTROLLER? Yes No            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > THE TEMPERATURE RECORDER SENSING BULB IS INSTALLED IN THE Retort    |
| > Shell External Well                                                 |
| >                                                                     |
| > IF THE TEMPERATURE SENSING BULB IS INSTALLED IN AN EXTERNAL WELL,   |
| > HOW DOES THE FIRM INSURE THAT THE                                   |
| >                                                                     |
| > TEMPERATURE SENSED IS REPRESENTATIVE OF THE TEMPERATURE IN THE      |
| > RETORT SHELL?\                                                      |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **AUTOMATIC STEAM CONTROLLER**                                      |
+-----------------------------------------------------------------------+
| > IS THE STEAM CONTROLLER AUTOMATIC? Yes No                           |
| >                                                                     |
| > *(EACH RETORT **[SHALL]{.underline}** BE EQUIPPED WITH AN AUTOMATIC |
| > STEAM CONTROLLER TO MAINTAIN THE RETORT\                            |
| > TEMPERATURE -- 113.40(a)(4).)*                                      |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE STEAM CONTROLLER TEMPERATURE ACTUATED? Yes No                |
| >                                                                     |
| > EXPLAIN THE OPERATION OF THE TEMPERATURE CONTROL SYSTEM:\           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > REPORT THE **MANUFACTURER**, **MODEL**, **TYPE** AND **SIZE** OF    |
| > THE AUTOMATIC STEAM CONTROL VALVE:\                                 |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IF THE TEMPERATURE (STEAM) CONTROLLER IS AIR OPERATED, DOES THE     |
| > SYSTEM HAVE AN ADEQUATE FILTER TO\                                  |
| > ASSURE A SUPPLY OF CLEAN, DRY AIR? Yes No                           |
| >                                                                     |
| > *(AIR OPERATED TEMPERATURE CONTROLLERS SHOULD HAVE ADEQUATE FILTER  |
| > SYSTEMS TO ASSURE A SUPPLY OF*                                      |
| >                                                                     |
| > *CLEAN, DRY AIR -- 113.40(a)(2).)*                                  |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **COME UP PROCEDURE**                                               |
+-----------------------------------------------------------------------+
| > DOES THE FIRM USE A STEAM BYPASS DURING COME UP? Yes No             |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM (VENT) PURGE AIR FROM THE RETORT PRIOR TO THE THERMAL |
| > PROCESS? Yes No                                                     |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE THE FIRMS PURGE PROCEDURE:\                                |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DESCRIBE THE PROCEDURES USED BY THE FIRM TO BRING THE RETORT UP TO  |
| > OPERATING TEMPERATURE:\                                             |
| >                                                                     |
+-----------------------------------------------------------------------+
| > CAN THE FIRM DOCUMENT ALL STEPS OF THE COME UP PROCEDURE? Yes No    |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM IDENTIFY PROCESS COME UP STEPS AS CRITICAL ON THE     |
| > PROCESS FILING FORMS?                                               |
| >                                                                     |
| > Yes No                                                              |
| >                                                                     |
| > *(NOTE: PROCESSING STEPS ARE REQUIRED ON THE PROCESS FILING FORM    |
| > WHEN THEY HAVE BEEN IDENTIFIED AS\                                  |
| > CRITICAL TO THE THERMAL PROCESS.)*                                  |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **HEAT/TEMPERATURE DISTRIBUTION**                                   |
+-----------------------------------------------------------------------+
| > DOES THE FIRM HAVE ON HAND TEMPERATURE DISTRIBUTION DATA OR OTHER   |
| > SUITABLE INFORMATION THAT\                                          |
| > DEMONSTRATES THAT HEAT DISTRIBUTION IN THE RETORT IS ADEQUATE? Yes  |
| > No                                                                  |
+-----------------------------------------------------------------------+
| > EXPLAIN AND PROVIDE COPIES OF SUPPORTING DOCUMENTS:\                |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DATE OF LAST TEMPERATURE DISTRIBUTION STUDY: [     ]{.underline}    |
| >                                                                     |
| > *NOTE: THE FOLLOWING PARAMETERS (RETORT INSTALLATION, COME UP       |
| > PROCEDURES, CONTAINER TYPE, CONTAINER*                              |
| >                                                                     |
| > *SIZE, CONTAINER POSITION, PRODUCT TYPE, OPERATING PRESSURE, CRATE  |
| > AND RACK DESIGN, AND PARTIAL LOADS)*                                |
| >                                                                     |
| > *MAY OR MAY NOT EFFECT TEMPERATURE DISTRIBUTION IN THE RETORT. ANY  |
| > FACTOR, THAT CAN INFLUENCE THE*                                     |
| >                                                                     |
| > *MIXING OF STEAM-AIR IN THE RETORT, CAN POTENTIALLY HAVE AN EFFECT  |
| > ON TEMPERATURE DISTRIBUTION IN THE*                                 |
| >                                                                     |
| > *RETORT.*                                                           |
+-----------------------------------------------------------------------+
| > HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH         |
| > INDIVIDUAL RETORT? Yes No                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH         |
| > CONTAINER SIZE? Yes No                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH         |
| > CONTAINER TYPE *(E.G., GLASS, METAL,\                               |
| > PLASTIC)* Yes No                                                    |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH         |
| > CONTAINER HOLDING ARRANGEMENT/\                                     |
| > RACKING SYSTEM USED BY THE FIRM? Yes No                             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH         |
| > INDIVIDUAL PRODUCT OR PRODUCT TYPE?\                                |
| > *(E.G., SEAFOOD SOUP VERSUS CANNED TUNA)* Yes No                    |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DID EACH TEMPERATURE DISTRIBUTION STUDY IDENTIFY A COLD SPOT IN THE |
| > RETORT? Yes No                                                      |
| >                                                                     |
| > PROVIDE LOCATION AND EXPLAIN:\                                      |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE   |
| > THE EFFECTS OF TEMPERATURE\                                         |
| > DROPS DURING COME UP AND PROCESSING? Yes No                         |
| >                                                                     |
| > REPORT RESULTS:\                                                    |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE   |
| > THE EFFECTS OF PRESSURE DROPS\                                      |
| > OR EXCESS PRESSURE IN THE RETORT? Yes No                            |
| >                                                                     |
| > REPORT RESULTS:\                                                    |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE PARTIAL LOADS PROCESSED IN THE FIRMS RETORTS? Yes No            |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE BAFFLE PLATES OR DUMMY LOADS USED DURING THE PROCESSING OF      |
| > PARTIAL LOADS? Yes No                                               |
| >                                                                     |
| > EXPLAIN:\                                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED WITH PARTIAL   |
| > LOADS? Yes No                                                       |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **RETORT CRATES, RACKS**                                            |
+-----------------------------------------------------------------------+
| > DESCRIBE THE RETORT CRATES.                                         |
| >                                                                     |
| > DIMENSIONS:                                                         |
| >                                                                     |
| > NUMBER OF HOLES:                                                    |
| >                                                                     |
| > SIZE OF HOLES:                                                      |
| >                                                                     |
| > LOCATION OF HOLES:                                                  |
+-----------------------------------------------------------------------+
| > ARE CONTAINERS POSITIONED IN THE RETORT AS SPECIFIED IN THE         |
| > SCHEDULED PROCESS? Yes No                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE DIVIDERS, TRAYS, RACKS OR OTHER MEANS OF POSITIONING FLEXIBLE   |
| > CONTAINERS DESIGNED AND EMPLOYED TO\                                |
| > INSURE EVEN CIRCULATION OF HEATING MEDIUM AROUND ALL CONTAINERS?    |
| > Yes No                                                              |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE DIVIDER PLATES USED? Yes No                                     |
| >                                                                     |
| > DESCRIBE NUMBER OF HOLES AND DISTRIBUTION IN DIVIDER PLATES:\       |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE SAME TYPE OF DIVIDER PLATE USED FOR ALL CONTAINERS? Yes No   |
| >                                                                     |
| > DESCRIBE DIFFERENCES:\                                              |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE CONTAINERS PROCESSED WITHOUT DIVIDER PLATES? Yes No             |
| >                                                                     |
| > DESCRIBE STACKING ARRANGEMENT (E.G., BRICK , OFFSET, JUMBLE):\      |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS CONTAINER NESTING POSSIBLE? . Yes No                             |
| >                                                                     |
| > HOW DOES FIRM CONTROL NESTING OF CONTAINERS?\                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM PROCESS?                                              |
| >                                                                     |
| > Metal Cans Yes No                                                   |
| >                                                                     |
| > Glass Jars Yes No                                                   |
| >                                                                     |
| > Pouches Yes No                                                      |
| >                                                                     |
| > Rigid Plastic Yes No                                                |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > DOES THE FIRM PROCESS MORE THAN ONE CONTAINER SIZE? Yes No          |
| >                                                                     |
| > LIST ALL CONTAINER SIZES:                                           |
| >                                                                     |
| > METAL CANS --                                                       |
| >                                                                     |
| > GLASS JARS --                                                       |
| >                                                                     |
| > POUCHES --                                                          |
| >                                                                     |
| > RIGID PLASTIC --                                                    |
| >                                                                     |
| > IF MORE THAN ONE CONTAINER SIZE OR TYPE IS PROCESSED AT ONE TIME    |
| > DESCRIBE PROCEDURE USED:\                                           |
| >                                                                     |
+-----------------------------------------------------------------------+
| > FOR POUCHES, ARE TRAYS ADEQUATELY DESIGNED WITH POCKETS TO CONTAIN  |
| > AND RESTRAIN INDIVIDUAL POUCHES\                                    |
| > DURING PROCESSING? Yes No                                           |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > ARE TRAYS OR DIVIDER PLATES IN GOOD CONDITION WITH NO ROUGH OR      |
| > SHARP POINTS THAT COULD PUNCTURE\                                   |
| > CONTAINERS? Yes No                                                  |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **CONTAINER COOLING**                                               |
+-----------------------------------------------------------------------+
| > CONTAINERS ARE COOLED BY: Air Water                                 |
| >                                                                     |
| > EXPLAIN CONTAINER COOLING:\                                         |
| >                                                                     |
+-----------------------------------------------------------------------+
| > TYPE OF VALVE ON COOLING WATER LINES:\                              |
| >                                                                     |
+-----------------------------------------------------------------------+
| > WERE COOLING WATER LINES NOTED TO BE LEAKING? Yes No                |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **WATER DRAINS**                                                    |
+-----------------------------------------------------------------------+
| > ARE SCREENS USED OVER ALL DRAIN OPENINGS TO PREVENT CLOGGING OF     |
| > DRAINS? Yes No                                                      |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+
| > IS THE DRAIN VALVE WATER TIGHT AND NON-CLOGGING? Yes No             |
| >                                                                     |
| > COMMENTS:\                                                          |
| >                                                                     |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > **OTHER CONCERNS AND OBSERVATIONS**                                 |
+-----------------------------------------------------------------------+
| > PLEASE EXPLAIN ANY OTHER CONCERNS WITH THE OPERATION OF THIS RETORT |
| > SYSTEM:\                                                            |
| >                                                                     |
+-----------------------------------------------------------------------+