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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

PROCESSING IN STEAM IN STILL 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 and attach it to the EIR as an exhibit. Report all pipe sizes as inside diameter (ID). Cross-sectional area = 3.14r 2 (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.
RETORT DESCRIPTION
RETORT NO. TYPE OF RETORT Vertical Horizontal Vertical (Crateless) FOR VERTICAL RETORTS, BOTTOM CRATE SUPPORTS ARE PRESENT. ............................................................... Yes No LENGTH OR HEIGHT DIAMETER

(SHALL REQUIREMENT)
COMMENTS:

ARE BAFFLE PLATES PRESENT IN THE BOTTOM OF RETORT? .............................................................................. Yes

No

(SHALL NOT BE USED IN THE BOTTOM OF STEAM STILL RETORTS (113.40(a)(6)) ­ BAFFLE PLATES ARE UNDESIRABLE IN THE BOTTOM OF STILL STEAM RETORTS BECAUSE THEY CAN IMPEDE THE FLOW OF STEAM FROM STEAM INLETS OR PERFORATED STEAM DISTRIBUTOR PIPES.)
COMMENTS:

ARE THERE ANY PROTRUSIONS INSIDE THE RETORT OR THE RETORT DOOR CASING WHICH COULD DAMAGE CONTAINERS DURING LOADING/UNLOADING OF CRATES? .................................................................................... Yes COMMENTS:

No

COMPUTER CONTROLS
DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? ..................................................................... Yes COMMENTS: No

DOES THE FIRM HAVE DOCUMENTATION ON HAND THAT INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED? Yes EXPLAIN: No

IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? ................................................................................. Yes IF YES, DOES THE RECORD KEEPING COMPLY WITH 21CFR PART 11? ................................................................ Yes FORM FDA 3511a (3/07) PAGE 1

No No

PSC Graphics (301) 443-1090

EF

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IF CRATE POSITION HAS BEEN DETERMINED CRITICAL TO THE PROCESS, WHAT IS THE RECOMMENDED POSITION AND HOW WAS IT DETERMINED? (FOR EXAMPLE, PROCESS ESTABLISHMENT TESTS MAY HAVE DETERMINED THAT AN ANGLED CRATE POSITION RESULTS IN FASTER HEAT PENETRATION.)

PROCESSING WATER
METHOD USED TO HEAT PROCESS WATER: A. Steam Injection Into Process Water IF OTHER, EXPLAIN: B. Heat Exchanger C. Steam Spreader D. Other

WATER DRAINS
ARE SCREENS USED OVER ALL DRAIN OPENINGS TO PREVENT CLOGGING OF DRAINS? ............................. Yes COMMENTS: No

IS THE DRAIN LINE VALVE WATER TIGHT AND NON-CLOGGING ............................................................................. Yes COMMENTS:

No

WATER DISTRIBUTION
WATER DISTRIBUTION SYSTEM: Manifold Plate? .................... Yes Spray Nozzle Heads? .................... Yes Manifold Pipe? .................... Yes Other? .................... Yes IF OTHER, EXPLAIN: No No No

DESCRIBE HOLE SIZE AND DISTRIBUTION IN MANIFOLD/SPRAY NOZZLES:

HAVE HOLE SIZES BEEN ALTERED BY PRODUCT OR MINERAL BUILD-UP? ......................................................... Yes COMMENTS:

No

DOES THE FIRM HAVE A CLEANING PROGRAM FOR THE WATER DISTRIBUTION SYSTEM? ............................ Yes COMMENTS:

No

HOW DOES THE FIRM INSURE THAT WATER FLOW IS CONSTANT? Visual Checks .................... Yes Water Flow Measurement .................... Yes Flow Meter .................... Yes FORM FDA 3511e (3/07) No No No PAGE 2

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COMMENTS:

HOW OFTEN IS WATER FLOW CHECKED?

WHAT IS THE WATER FLOW RATE?

DESCRIBE THE PROCEDURE TO INSURE WATER FLOW IS MAINTAINED:

PROVIDE THE WATER FLOW METER MODEL NUMBER AND LOCATION:

AT WHAT POINT DOES WATER ENTER THE RETORT WATER DISTRIBUTION SYSTEM? Back Top .................... Yes Back Bottom .................... Yes Front Top .................... Yes Front Bottom .................... Yes Center .................... Yes Multiple .................... Yes COMMENTS: No No No No No No

EXPLAIN THE WATER DISTRIBUTION SYSTEM:

DESCRIBE THE WATER RETURN SYSTEM:

ARE WATER RETURN INLETS SCREENED? ................................................................................................................. Yes EXPLAIN, IF NECESSARY:

No

IS THE PROCESSING WATER REUSED? ....................................................................................................................... Yes EXPLAIN, IF NECESSARY:

No

IF WATER IS REUSED DURING THERMAL PROCESSING, WHAT IS THE RECIRCULATION RATE?

FORM FDA 3511e (3/07)

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WHAT IS THE CAPACITY OF THE WATER PUMP (GPM/LPM)?

IS WATER FLOW IDENTIFIED AND CONTROLLED AS A FACTOR CRITICAL TO THE THERMAL PROCESS? ......... Yes COMMENTS:

No

ARE WATER FLOW PROBLEMS HANDLED AS PROCESS DEVIATIONS? ................................................................. Yes COMMENTS:

No

DURING THE INSPECTION, WAS THERE ANY EVIDENCE OF LOW WATER FLOW? .............................................. Yes COMMENTS:

No

COOLING WATER SUPPLY
IS PROCESSING WATER USED TO COOL CONTAINERS DURING THE COOLING CYCLE? .................................. Yes COMMENTS: No

IF WATER IS INTRODUCED FROM AN EXTERIOR SOURCE DURING COOLING, IS THE WATER COOLING LINE EQUIPPED WITH A CHECK VALVE? ................................................................................................................................ Yes No N/A COMMENTS:

INDICATING MERCURY IN-GLASS THERMOMETERS (113.40(e)(1))
IS THE RETORT EQUIPPED WITH AT LEAST ONE MERCURY-IN-GLASS (MIG) THERMOMETER? ...................... Yes COMMENTS: No

IS THE RETORT EQUIPPED WITH A TEMPERATURE INDICATING DEVICE OTHER THAN A MERCURY-IN-GLASS THERMOMETER? .............................................................................................................................................................. Yes IF YES, DESCRIBE THE INDICATOR:

No

ARE SCALE DIVISIONS EASILY READABLE TO 1°F (.5°C)? ........................................................................................ Yes NO. OF DEGREES F OR C/IN. OF GRADUATED SCALE: INCH (4°C PER CM) OF GRADUATED SCALE. SEE LACF GUIDE, P. 14.) DATE LAST TESTED FOR ACCURACY: COMMENTS:

No

. (TEMP. RANGE MUST NOT EXCEED 17°F (8°C) PER

STANDARD USED FOR THE TEST:

NAME AND TITLE OF PERSON WHO PERFORMED TEST:

FORM FDA 3511e (3/07)

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IS THE LAST TEST DATE IDENTIFIED ON THE THERMOMETER? ............................................................................. Yes WERE CALIBRATING TEST RECORDS PREPARED AND MAINTAINED? ................................................................... Yes COMMENTS:

No No

DESCRIBE THE FIRM'S ACTIONS REGARDING MIG THERMOMETERS THAT WERE OUT OF CALIBRATION:

IS THE 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.)
COMMENTS:

WHEN MIG 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:

IS THE THERMOMETER LOCATED WHERE IT IS EASY TO READ ACCURATELY? .................................................. Yes

No

(SHALL REQUIREMENT)
COMMENTS:

THE SENSOR BULB IS LOCATED IN THE ...................................................................................... Retort Shell

, or External Well

(SHALL REQUIREMENT)
COMMENTS:

IS THE MERCURY THERMOMETER USED AS THE REFERENCED INSTRUMENT DURING PROCESSING? ...... Yes

No

(SHALL REQUIREMENT)
COMMENTS:

TEMERATURE RECORDER (113.40(e)(2))
TYPE OF TEMPERATURE RECORDER .......................................................... Round Circular Chart IF OTHER, EXPLAIN: Strip Chart Other

DO THE CHART SPECIFICATIONS MEET THE REQUIREMENTS OF PART 113.40(e)(2)? ....................................... Yes

No

(GRADUATIONS ON THE TEMPERATURE-RECORDING DEVICE SHALL NOT EXCEED 2°F (1°C) WITHIN A RANGE OF 10°F (5.5°C) OF THE PROCESSING TEMPERATURE. EACH CHART SHALL HAVE A WORKING SCALE OF NOT MORE THAN 55°F/IN (12°C/CM) WITHIN A RANGE OF 20°F (10°C) OF THE PROCESSING TEMPERATURE ­ 113.40(E)(2)). ALSO, SEE P. 14 OF LACF FIELD GUIDE-PART 2.)
COMMENTS:

FORM FDA 3511e (3/07)

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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 REQUIREMENT; NOTE ANY DIFFERENCE BETWEEN THE RECORDING THERMOMETER AND THE MERCURY-INGLASS THERMOMETER AND WHICH READING IS HIGHER.)
COMMENTS:

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.)
COMMENTS:

IS THE CHART DRIVE TIMING MECHANISM ACCURATE? .......................................................................................... Yes IF NO, EXPLAIN:

No

IS THE RECORDER COMBINED WITH A TEMPERATURE (STEAM) CONTROLLER TO FUNCTION AS A RECORDING/ CONTROLLING INSTRUMENT? ....................................................................................................................................... Yes COMMENTS:

No

TEMPERATURE CONTROLLER
HOW IS TEMPERATURE CONTROLLED IN THE RETORT? Recorder Controller COMMENTS: CAM Controller Manual Switching Computer

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(E)(2).)
COMMENTS:

COME-UP PROCEDURE
DESCRIBE THE FIRM'S PROCEDURE TO BRING THE RETORT UP TO PROCESSING TEMPERATURE. INCLUDE TIME, TEMPERATURE AND NUMBER OF STEPS:

CAN THE FIRM DOCUMENT ALL STEPS OF THE COME-UP PROCEDURE? ........................................................... Yes

No

FORM FDA 3511e (3/07)

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COMMENTS:

DOES THE FIRM IDENTIFY PROCESS COME-UP STEPS AS CRITICAL ON THE PROCESSING 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. THIS IS ALWAYS THE CASE WHEN THE GENERAL METHOD IS USED TO CALCULATE THE FO .)

AIR PURGE
IN SOME SYSTEMS AN AIR PURGE (VENT VALVE) IS USED TO ENHANCE WATER ENTRY INTO THE PROCESSING VESSEL; IS AN AIR PURGE VALVE USED ON THE PROCESSING VESSEL? ................................................................................ Yes No COMMENTS:

HAS TIMING OF THE AIR PURGE VALVE (TIME OPEN) BEEN IDENTIFIED AS CRITICAL TO ADEQUATE TEMPERATURE DISTRIBUTION IN THE RETORT? ................................................................................................................................... Yes No COMMENTS:

HEATED PROCESS WATER
IS WATER PREHEATED IN A SEPARATE VESSEL PRIOR TO PROCESSING? .......................................................... Yes No

IS THE WATER TEMPERATURE OF THE PREHEATED WATER CRITICAL TO TEMPERATURE DISTRIBUTION IN THE RETORT? Yes COMMENTS: No

DESCRIBE THE TEMPERATURE REQUIREMENTS FOR PREHEATED WATER:

DID THE FIRM MEET THE REQUIREMENTS FOR PREHEATING WATER DURING THIS INSPECTION? ............... Yes EXPLAIN:

No

TEMPERATURE DISTRIBUTION
HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED ON THE FIRM'S RETORTS? ..................... Yes COMMENTS: No

DATE OF LAST TEMPERATURE DISTRIBUTION STUDY:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH INDIVIDUAL RETORT? ............... Yes COMMENTS:

No

FORM FDA 3511e (3/07)

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HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH CONTAINER SIZE? ..................... Yes COMMENTS:

No

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 PRODUCT OR PRODUCT TYPE? Yes COMMENTS: No

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE THE EFFECTS OF TEMPERATURE DROPS DURING COME-UP AND PROCESSING? ......................................................................................................... Yes No REPORT RESULTS:

ARE PARTIAL LOADS PROCESSED IN THE FIRM'S RETORTS? ................................................................................ Yes COMMENTS:

No

RETORT CRATES & RACKS
DESCRIBE THE RETORT CRATES: DIMENSIONS: NUMBER OF HOLES: SIZE OF HOLES: LOCATION OF HOLES: CRATES/BASKETS NOT USED COMMENTS:

ARE CONTAINERS POSITIONED IN THE RETORT AS SPECIFIED IN THE SCHEDULED PROCESS? .................. Yes COMMENTS:

No

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

FORM FDA 3511e (3/07)

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DESCRIBE NUMBER OF HOLES AND DISTRIBUTION IN DIVIDER PLATES:

IS THE SAME TYPE OF DIVIDER PLATE USED FOR ALL CONTAINERS? .............................................. Yes COMMENTS:

No

N/A

ARE CONTAINERS PROCESSED WITHOUT DIVIDER PLATES? ................................................................................ Yes COMMENTS:

No

CONTAINER NESTING WHERE ONE CONTAINER OR MORE ARE POSITIONED ONE INSIDE ANOTHER TO REPRESENT A MUCH LARGER CONTAINER MAY OCCUR WITH PRODUCTS DESIGNED TO STACK ON STORE SHELVES E.G. TUNA, SARDINES. IS CONTAINER NESTING POSSIBLE? ........................................................................................................................... Yes HOW DOES THE FIRM CONTROL NESTING OF CONTAINERS? No

WAS CONTAINER NESTING EVALUATED AS PART OF THE PROCESS ESTABLISHMENT .................................... Yes COMMENTS:

No

WHICH OF THE FOLLOWING CONTAINER TYPES ARE PROCESSED? Metal Cans COMMENTS: Glass Jars Pouches Rigid Plastic

DOES THE FIRM PROCESS MORE THAN ONE CONTAINER SIZE? .......................................................................... Yes 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 PROCEDURES USED:

No

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 SHARP OR ROUGH POINTS THAT COULD PUNCTURE CONTAINERS? ................................................................................................................................................................... Yes No COMMENTS:

FORM FDA 3511e (3/07)

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PRESSURE CONTROL
ARE PRODUCTS PRODUCED USING OVERPRESSURE? .......................................................................................... Yes IF YES, WHAT OVERPRESSURE IS ACHIEVED? No

IS THE RETORT EQUIPPED WITH A PRESSURE GAGE? ........................................................................................... Yes COMMENTS:

No

IS A MEANS PROVIDED FOR INTRODUCING COMPRESSED AIR OR STEAM AT THE PROPER PRESSURE AND RATE? Yes COMMENTS: No

IS THE PRESSURE IN THE RETORT CONTROLLED BY AN AUTOMATIC PRESSURE CONTROL UNIT? ............. Yes (SHALL REQUIREMENT) COMMENTS:

No

IF A PRESSURE GAGE IS PRESENT ON THE RETORT COOKER SHELL, IS IT GRADUATED IN DIVISIONS OF 2 LBS. OR LESS? Yes No

(NOTE: THIS IS A RECOMMENDATION ­ "SHOULD" REQUIREMENT ­ 113.40(e)(3).)
COMMENTS:

DESCRIBE THE LOCATION WHERE COMPRESSED AIR OR STEAM ENTERS THE RETORT:

IS COMPRESSED AIR USED FOR OVERPRESSURE HEATED PRIOR TO INTRODUCTION INTO THE RETORT? Yes COMMENTS: No N/A

IS A DIFFUSER USED ON THE COMPRESSED AIR ENTRY LINE TO INSURE RAPID MIXING OF THE AIR IN THE RETORT ATMOSPHERE? ................................................................................................................................................................. Yes No COMMENTS:

HAS THE POINT WHERE AIR ENTERS THE RETORT BEEN IDENTIFIED AS A COLD SPOT IN THE RETORT? Yes COMMENTS: No N/A

EXPLAIN HOW PRESSURE IS CONTROLLED IN THE RETORT:

FORM FDA 3511e (3/07)

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HAS OVERPRESSURE BEEN IDENTIFIED AS CRITICAL TO THE THERMAL PROCESS? ...................................... Yes COMMENTS:

No

ARE PRESSURE DROPS CONSIDERED PROCESS DEVIATIONS? ........................................................................... Yes WHY OR WHY NOT? (AND ANY OTHER COMMENTS)

No

RETORT SPEED TIMING (113.40(e)(5))
IS THE ROTATIONAL SPEED OF THE RETORT SPECIFIED IN THE SCHEDULED PROCESS? .............................. Yes No

(SHALL REQUIREMENT)
COMMENTS:

IS THE ROTATIONAL SPEED OF THE RETORT ADJUSTED, AS NECESSARY, TO ENSURE THAT THE SPEED IS AS SPECIFIED IN THE SCHEDULED PROCESS? .................................................................................................................................... Yes No

(SHALL REQUIREMENT)
COMMENTS:

IS THE ROTATIONAL SPEED OF THE RETORT AND THE PROCESS TIME RECORDED FOR EACH RETORT LOAD PROCESSED? PROCESS TIME ................................................................................................................................ Yes ROTATIONAL SPEED ........................................................................................................................ Yes No No

(SHALL REQUIREMENT)
IF NO, IS A RECORDING TACHOMETER USED TO PROVIDE A CONTINUOUS RECORD OF THE SPEED? ........ Yes No

(SHALL REQUIREMENT)
IF NO TO THE ABOVE 2 QUESTIONS, HOW DOES THE FIRM MONITOR AND RECORD THE RETORT SPEED AND PROCESS TIME OF EACH RETORT LOAD PROCESSED?

OTHER COMMENTS:

DOES THE FIRM HAVE A MEANS OF PREVENTING UNAUTHORIZED SPEED CHANGES ON THE RETORT? ... Yes

No

(SHALL REQUIREMENT; A LOCK OR NOTICE FROM MANAGEMENT POSTED AT OR NEAR THE SPEED ADJUSTMENT DEVICE THAT PROVIDES A WARNING THAT ONLY AUTHORIZED PERSONS ARE PERMITTED TO MAKE ADJUSTMENTS, IS A SATISFACTORY MEANS OF PREVENTING UNAUTHORIZED CHANGES.)
COMMENTS:

EXPLAIN HOW THE RETORT ROTATIONAL SPEED IS MONITORED AND RECORDED:

OTHER CONCERNS AND OBSERVATIONS
EXPLAIN ANY OTHER CONCERNS WITH THE OPERATION OF THIS RETORT SYSTEM:

FORM FDA 3511e (3/07)

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