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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

PROCESSING IN STEAM IN DISCONTINUOUS AGITATING 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). Refer to 21CFR Part 113.40(d) and p 31 of LACF Guide Part 2. 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.

*CAN SIZE


COOKER CAPACITY




STEPS/REEL

PROCESSING MODE Axial
* List the Can Size covered during the inspection.

End-over-End

Rocking

COMPUTER CONTROLS
DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS? ................................................................. Yes EXPLAIN: 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 21 CFR PART 11? ............................................................. Yes COMMENTS:

No No

INDICATING MERCURY IN-GLASS THERMOMETERS (113.40(d)(1))
IS EACH RETORT EQUIPPED WITH AT LEAST ONE MERCURY-IN-GLASS (MIG) THERMOMETER? ................ Yes No

IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATING DEVICE? ....................... 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: PER INCH (4°/CM) OF GRADUATED SCALE. SEE LACF GUIDE, P. 14.) DATE LAST TESTED FOR ACCURACY: FORM FDA 3511d (3/07) PAGE 1

No

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

PSC Graphics (301) 443-1090

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COMMENTS:

STANDARD USED FOR THE TEST:

NAME AND TITLE OF PERSON WHO PERFORMED TEST:

IS THE LAST TEST DATE IDENTIFIED ON THE THERMOMETER ............................................................................. Yes WERE CALIBRATING TEST RECORDS PREPARED/MAINTAINED ............................................................................ Yes

No No

(SHOULD REQUIREMENT)
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 (SHALL REQUIREMENT) COMMENTS:

, or External Well

DIAMETER OF OPENING FROM RETORT TO EXTERNAL WELL:

BLEEDER SIZE:

(OPENING SHALL BE AT LEAST 3/4-IN. DIA.)
COMMENTS:

(BLEEDER SHALL BE AT LEAST 1/6-IN. DIA.)

DOES THE BLEEDER EMIT STEAM CONTINUOUSLY DURING PROCESSING? .................................................... Yes

No

(SHALL REQUIREMENT)
IF NO, EXPLAIN:

FORM FDA 3511d (3/07)

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IF A MUFFLER IS USED ON BLEEDER(S), WHAT EVIDENCE DOES THE FIRM HAVE THAT IT DOES NOT RESTRICT FREE FLOW OF STEAM?

(SHALL REQUIREMENT ­ 113.87(G))
COMMENTS:

IS THE MERCURY THERMOMETER USED AS THE REFERENCED INSTRUMENT DURING PROCESSING? ... Yes (SHALL REQUIREMENT) COMMENTS:

No

TEMERATURE RECORDING DEVICE (113.40(d)(2))
IS EACH RETORT EQUIPPED WITH A TEMPERATURE RECORDING DEVICE? .................................................... Yes TYPE OF TEMPERATURE RECORDER ....................................................... Round Circular Chart IF OTHER, EXPLAIN: Strip Chart No Other

DO THE CHART SPECIFICATIONS MEET THE REQUIREMENTS OF PART 113.40(D)(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(B)(2). ALSO, SEE P. 14 OF LACF FIELD GUIDE-PART 2.)
COMMENTS:

IS THE TEMPERATURE CHART ADJUSTED TO AGREE AS NEARLY AS POSSIBLE WITH BUT NOT HIGHER THAN THE No KNOWN ACCURATE MERCURY-IN-GLASS THERMOMETER DURING THE PROCESSING PERIOD? ............... Yes

(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 STEAM CONTROLLER TO FUNCTION AS A RECORDING/CONTROLLING INSTRUMENT? .................................................................................................................................................................. Yes COMMENTS:

No

FORM FDA 3511d (3/07)

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THE TEMPERATURE SENSING BULB IS INSTALLED IN THE ..................................................... Retort Shell

, or External Well

(THE TEMPERATURE-RECORDER BULB SHALL BE INSTALLED EITHER WITHIN THE RETORT SHELL OR IN A WELL ATTACHED TO THE SHELL.)
COMMENTS:

DOES THE TEMPERATURE RECORDER BULB WELL HAVE A 1/16-IN. DIA. OR LARGER BLEEDER THAT EMITS STEAM CONTINUOUSLY DURING THE PROCESSING PERIOD? ....................................................................... Yes No N/A

(SHALL REQUIREMENT)
COMMENTS:

IF A MUFFLER IS USED ON THE BLEEDER, DOES THE FIRM HAVE DOCUMENTED EVIDENCE THAT IT DOES NOT BLOCK THE FLOW OF STEAM? ............................................................................................................................... Yes No N/A

(SHALL REQUIREMENT ­ 113.87(G))
COMMENTS:

PRESSURE GAGE (113.40(d)(3))
IF A PRESSURE GAGE IS PRESENT ON THE RETORT COOKER SHELL, IS IT GRADUATED IN DIVISIONS OF 2 LBS. OR LESS? Yes No

(SHOULD REQUIREMENT)
IS THE PRESSURE COOLING SHELL EQUIPPED WITH A PRESSURE GAGE? ..................................................... Yes COMMENTS: No

STEAM CONTROLLER (113.40(d)(4))
IS THE STEAM CONTROLLER AUTOMATIC? ............................................................................................................... Yes No

(EACH RETORT SHALL BE EQUIPPED WITH AN AUTOMATIC STEAM CONTROLLER TO MAINTAIN THE RETORT TEMPERATURE)
COMMENTS:

IS THE STEAM CONTROLLER TEMPERATURE OR PRESSURE ACTUATED? ........................................... Temp.

Press.

(THE STEAM CONTROLLER MAY BE ACTIVATED BY A TEMPERATURE SENSOR POSITIONED NEAR THE MERCURY-INGLASS THERMOMETER; A STEAM CONTROLLER ACTIVATED BY THE STEAM PRESSURE OF THE RETORT IS ACCEPTABLE IF IT IS CAREFULLY MAINTAINED SO IT OPERATES SATISFACTORILY.)
COMMENTS:

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

FORM FDA 3511d (3/07)

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(AIR OPERATED TEMPERATURE CONTROLLERS SHOULD HAVE ADEQUATE FILTER SYSTEMS TO ASSURE A SUPPLY OF CLEAN, DRY AIR ­ 113.40(d)(2).)
COMMENTS:

BLEEDERS (113.40(d)(5))
ARE BLEEDERS (EXCEPT THOSE FOR THERMOMETER WELLS) 1/8-INCH OR LARGER IN DIAMETER? ...... Yes No

(SHALL REQUIREMENT)
COMMENTS:

ARE THESE BLEEDERS LOCATED ALONG THE TOP OF THE RETORT NO MORE THAN 8 FT. APART AND WITHIN APPROXIMATELY 1 FT. OF THE OUTERMOST LOCATION OF CONTAINERS AT EACH END? ............................ Yes

No

(SHALL REQUIREMENT)
COMMENTS:

ARE THE BLEEDERS ARRANGED SO THE OPERATOR CAN OBSERVE THAT THEY ARE OPERATING PROPERLY? Yes No

(SHALL REQUIREMENT)
COMMENTS:

ARE THE BLEEDERS WIDE OPEN DURING THE ENTIRE PROCESS INCLUDING THE COME-UP TIME? ......... Yes

No

(SHALL REQUIREMENT)
COMMENTS:

IF A MUFFLER IS USED ON BLEEDERS, DOES THE FIRM HAVE DOCUMENTED EVIDENCE THAT IT DOES NOT RESTRICT No N/A FREE FLOW OF STEAM? ............................................................................................................................. Yes

(SHALL REQUIREMENT ­ 113.87(G))
COMMENTS:

VENTING & CONDENSATE REMOVAL (113.40(d)(5&6))
IS THE RETORT VENTED TO REMOVE AIR PRIOR TO PROCESSING? .................................................................. Yes No

(SHALL REQUIREMENT)
NUMBER OF VENTS: LOCATION: DIAMETER: LENGTH:

WHAT IS THE TYPE OF VENT VALVE? ..................................................................................... Gate IF OTHER, SPECIFY:

Plug Cock

Other

ARE VENTS FULLY OPEN DURING VENTING? ............................................................................................................ Yes

No

FORM FDA 3511d (3/07)

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IF NO, EXPLAIN:

DOES THE FIRM HAVE ON FILE DOCUMENTARY PROOF DEMONSTRATING THAT ADEQUATE VENTING IS ACHIEVED? Yes No

(SHALL REQUIREMENT (113.40(D)(6); HEAT DISTRIBUTION DATA AND/OR A LETTER FROM A COMPETENT PROCESS AUTHORITY DOCUMENTING THE LAST HEAT DISTRIBUTION TEST PERFORMED ON THE RETORT (DATE OF TEST, WHO PERFORMED THE TEST, THE RESULTING VENT SCHEDULE, ETC) WOULD BE ACCEPTABLE DOCUMENTATION.)
COMMENTS:

IS A STEAM BY-PASS VALVE USED DURING VENTING? ............................................................................................ Yes IF YES, EXPLAIN:

No

(NOTE: VENTING PROCEDURES AND ARRANGEMENTS MUST BE THE SAME AS USED DURING THE TEMPERATURE DISTRIBUTION STUDY THAT WAS CONDUCTED ON THE RETORT TO ESTABLISH THE VENT SCHEDULE.)

IF VENTS ARE EQUIPPED WITH MUFFLERS, SPECIFY TYPE AND PERFORMANCE CHARACTERISTICS. DOES THE FIRM No HAVE DOCUMENTED EVIDENCE THAT THE MUFFLER ALLOWS ADEQUATE VENTING? ................................... Yes

(SHALL REQUIREMENT ­ 113.87(G))
COMMENTS:

WHEN THE STEAM IS TURNED ON, IS THE DRAIN OPENED FOR A TIME SUFFICIENT TO REMOVE STEAM CONDENSATE No FROM THE RETORT? ...................................................................................................................................................... Yes

(SHOULD REQUIREMENT)
COMMENTS:

IS PROVISION MADE FOR CONTAINING DRAINAGE OF CONDENSATE DURING THE RETORT OPERATION? Yes No

(SHOULD REQUIREMENT; IN RETORTS HAVING TOP STEAM INLET AND BOTTOM VENTING, A BLEEDER SHALL BE INSTALLED IN THE BOTTOM OF THE RETORT TO REMOVE CONDENSATE ­ 113.40(d)(5).) (NOTE: A CONDENSATE TRAP OR BLEEDER LOCATED AT THE BOTTOM OF THE RETORT WOULD BE SUFFICIENT TO ASSURE CONTINUAL CONDENSATE REMOVAL.)
COMMENTS:

DESCRIBE THE PROCEDURES USED FOR CONDENSATE REMOVAL:

IF A CONDENSATE BLEEDER IS PRESENT AT THE BOTTOM OF THE RETORT, IS IT VISIBLE TO THE RETORT OPERATOR? Yes DOES IT CONTINUOUSLY EMIT STEAM DURING THE COME-UP AND THERMAL PROCESS? .......................... Yes COMMENTS: No No

FORM FDA 3511d (3/07)

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IS THE CONDENSATE BLEEDER CHECKED WITH SUFFICIENT FREQUENCY DURING THE PROCESSING OF EACH RETORT LOAD TO ASSURE ADEQUATE REMOVAL OF CONDENSATE? ............................................................................... Yes No ARE THESE OBSERVATIONS RECORDED AT THE TIME THEY ARE MADE? .......................................................... Yes No

(SHALL REQUIREMENT ­ 113.100(a))
COMMENTS:

RETORT SPEED TIMING (113.40(d)(7)
*IS THE ROTATIONAL SPEED OF THE RETORT ADJUSTED AS NECESSARY, TO ENSURE THAT THE SPEED IS AS SPECIFIED No IN THE SCHEDULED PROCESS? ................................................................................................................................... Yes

(SHALL REQUIREMENT)
COMMENTS:

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

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

IF NO, HOW DOES THE FIRM MONITOR AND RECORD THE RETORT SPEED AND PROCESS TIME OF EACH RETORT LOAD PROCESSED?

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.)
*THE REEL SPEED IS ADJUSTED TO PROVIDE FOR A SPECIFIC PROCESS TIME. MINIMUM REEL SPEEDS ARE NORMALLY DETERMINED DURING PROCESS ESTABLISHMENT TO PROVIDE FOR ADEQUATE PRODUCT AGITATION. REEL SPEEDS WHICH ARE GREATER THAN THE MINIMUM ESTABLISHED PROCESS MAY SHORTEN THE PROCESS TIME. REEL SPEEDS WHICH ARE SLOWER THAN THE MINIMUM REEL SPEED MAY NOT PROVIDE FOR ADEQUATE AGITATION OF THE PRODUCT. REEL SPEED AND PROCESS TIME CAN BE DETERMINED USING THE FOLLOWING FORMULAS. TO USE THESE FORMULAS, KNOWN VALUES CAN BE ENTERED INTO THE FORMULA TO DETERMINE UNKNOWN VALUES OR TO CHECK THE VALUES SUPPLIED BY THE FIRM ON THE PROCESS FILING FORM. THE CAPACITY OF THE RETORT IS NORMALLY STAMPED ON THE END OF THE COOKER REEL SHAFT. THE APPROXIMATE NUMBER OF REEL STEPS FOR THE FMC SYSTEM FOR EACH CONTAINER SIZE IS PROVIDED IN THE TABLE BELOW. PLEASE BE AWARE THAT SOME REELS MAY BE ALTERED. IN SOME CASES, THE FIRM MAY PROCESS A SMALLER CAN SIZE (E.G. 300 IN A 303 X 307 REEL).

CONTAINER SIZE

NUMBER OF STEPS PER TURN OF REEL

211 .................................................................. 56 300-303 .................................................................. 47 303-307 .................................................................. 42 401-404 .................................................................. 35 603 .................................................................. 24


DETERMINE THE REEL SPEED BY TIMING 10 REVOLUTIONS OF THE RETORT REEL AND REPORT RESULTS (IN SECONDS):

FORM FDA 3511d (3/07)

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CALCULATE THE ACTUAL PROCESS TIME USING THE FORMULA:

SECONDS FOR 10 REVS = (10 RVS)X(60 SECS) X (REEL STEPS) X (PROCESS TIME)/CAPACITY
ACTUAL PROCESS TIME =


MIN.


IS THE ACTUAL PROCESS TIME AT LEAST EQUAL TO THE MINIMUM PROCESS TIME FILED WITH FDA ....... Yes CALCULATE THE PROCESS SPEED IN CONTAINERS/MIN USING THE FORMULA:

No

CONTAINERS PER MINUTE = CAPACITY/PROCESS TIME (MIN)
CONTAINERS PER MINUTE =


CALCULATE THE REEL SPEED AS REVOLUTIONS PER MINUTE (RPM) USING THE FORUMLA:

RPM = CAPACITY/(REEL STEPS) X (PROCESS TIME)
REEL SPEED (RPM) =

IS THE REEL SPEED CALCULATED ABOVE AS CONTAINERS PER MINUTE AND/OR REVOLUTIONS PER MINUTE AT LEAST EQUAL TO THE MINIMUM REEL SPEED FILED WITH FDA? ...................................................................................... Yes No

(IF NO, THE LOT COULD BE UNDER PROCESSED AND SHOULD BE HANDLED AS A PROCESS DEVIATION.
ALTERNATE FORMULAS WHICH CAN BE USED TO DETERMINE SECONDS FOR 10 REVOLUTIONS OF THE REEL:

(10 REV) X (60 SECS) X (#REEL STEPS)/(CPM) (10 RVS) X (60 SEC)/RPM

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

FORM FDA 3511d (3/07)

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