Free FDA-3511i.p65 - Federal

Save As...

Print

Next Page

E-mail Form

Goto Page?

Reset Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

PROCESSING IN OTHER UNIQUE RETORT SYSTEMS
(Retort Survey)
INSTRUCTIONS

Complete the question blocks below. 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. This report is designed to capture information about unique retort systems that are not specifically mentioned in Part 113.40. These retorts must meet the requirements found in applicable sections of 113.40. The retort 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 unique retort systems. Photographs are an excellent means of enhancing the description of a retort system.
RETORT DESCRIPTION
RETORT NO. TYPE OF RETORT Vertical Horizontal Other RETORT MANUFACTURER: LENGTH OR HEIGHT DIAMETER

RETORT MODEL:

IDENTIFY THE PROCESSING MEDIUM: ........................................................................................ Steam EXPLAIN:

Water

Other

TEMPERATURE RANGE OF THERMAL PROCESS (E.G. 245/250/260 DEGREE F):

NUMBER OF BASKETS OR CRATES PER RETORT:

PROCESSING MODE: Static Still DESCRIBE OPERATION: Continuous Batch Agitating ­ End-over-End Axial Rocking Other

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

FORM FDA 3511i (3/06)

PAGE 1

PSC Graphics (301) 443-1090

EF

Save As...

Print

Next Page

Previous Page

E-mail Form

Goto Page?

Reset Form

IS RECORD KEEPING PART OF THE COMPUTER FUNCTION? ................................................................................. Yes IF YES, DOES THE RECORD KEEPING COMPLY WITH 21 CFR PART 11? ............................................................... Yes EXPLAIN:

No No

AGITATION
IS THE AGITATING RETORT OPERATED IN THE STILL MODE? .............................................................. Yes No N/A

IS THE POSITION OF THE CRATE IN THE RETORT CRITICAL TO THE COME UP AND/OR THERMAL PROCESS? Yes EXPLAIN: No N/A

EXPLAIN HOW THE RETORT CRATE POSITION WAS DETERMINED:

EXPLAIN HOW THE RETORT ROTATION SPEED IS DETERMINED:

EXPLAIN HOW THE RETORT ROTATION SPEED IS RECORDED:

MIG THERMOMETER/TEMPERATURE INDICATOR
IS THE RETORT EQUIPPED WITH A MIG THERMOMETER? ...................................................................................... Yes No

IS A MERCURY-IN-GLASS THERMOMETER USED AS THE REFERENCE INSTRUMENT DURING PROCESSING? Yes No

IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATOR DEVICE? ............................ Yes IF SO, DESCRIBE THE INDICATOR:

No

ARE TEMPERATURE INDICATOR SCALE DIVISIONS EASILY READABLE TO 1°F (.5°C)? ...................................... Yes

No

NO. OF DEGREES F OR C/IN. OF GRADUATED SCALE: . (TEMP. RANGE MUST NOT EXCEED 17°F(8°C) PER INCH (4°/CM) OF GRADUATED SCALE ­ 113.40(a)(1). ALSO, SEE LACF GUIDE, P. 14.)

DATE TEMPERATURE INDICATOR/MIG LAST TESTED FOR ACCURACY:

(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:

FORM FDA 3511i (3/06)

PAGE 2

Save As...

Print

Next Page

Previous Page

E-mail Form

Goto Page?

Reset Form

NAME AND TITLE OF PERSON WHO PERFORMED TEST:

IS THE LAST TEST DATE IDENTIFIED ON THE MIG THERMOMETER/TEMPERATURE INDICATOR? ................... Yes

No

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).)

WHEN MIG THERMOMETERS /TEMPERATURE INDICATORS ARE FOUND TO BE PROVIDING READINGS ABOVE THE ACTUAL PROCESSING TEMPERATURES, DOES THE FIRM EVALUATE PRODUCTS PRODUCED USING THOSE THERMOMETERS? Yes DESCRIBE THE FIRM'S PROCEDURES: No

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

No

THE INDICATOR SENSOR BULB IS LOCATED IN THE SYSTEM Retort Shell External Well After the Heat Exchanger Before the Heat Exchanger

DESCRIBE THE LOCATION OF THE INDICATOR SENSOR(S):

HOW DOES THE FIRM INSURE THAT THE TEMPERATURE INDICATED IS REPRESENTATIVE OF THE ACTUAL PROCESSING TEMPERATURE?

TEMPERATURE RECORDER
TYPE OF TEMPERATURE RECORDER: ......................................................... Round Circular Chart Strip Chart Other

DO THE CHART SPECIFICATIONS MEET THE REQUIREMENTS OF PART 113? ..................................................... 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.)

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 ­ 113.40(B)(2). NOTE ANY DIFFERENCE BETWEEN THE RECORDING THERMOMETER AND THE MERCURY-IN-GLASS/INDICATING THERMOMETER AND WHICH READING IS HIGHER.)

IS THERE A MEANS TO PREVENT 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).)

IS THE CHART DRIVE TIMING MECHANISM ACCURATE? .......................................................................................... Yes FORM FDA 3511i (3/06) PAGE 3

No

Save As...

Print

Next Page

Previous Page

E-mail Form

Goto Page?

Reset Form

IS THE RECORDER COMBINED WITH A STEAM CONTROLLER? ............................................................................. Yes

No

THE TEMPERATURE RECORDER SENSING BULB IS INSTALLED IN THE Retort Shell EXPLAIN: External Well After the Heat Exchanger Before the Heat Exchanger

TEMPERATURE (STEAM) CONTROLLER
IS THE STEAM CONTROLLER AUTOMATIC? ................................................................................................................ Yes No

HOW IS TEMPERATURE CONTROLLED IN THE RETORT? Recorder Controller EXPLAIN: Cam Controller Manual Switching Computer Other

WHERE IS THE CONTROLLER SENSOR LOCATED? Retort Shell EXPLAIN: External Well After the Heat Exchanger Before the Heat Exchanger

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).)

DURING THE INSPECTION ,WAS THERE ANY EVIDENCE OF TEMPERATURE DROPS? ...................................... Yes EXPLAIN:

No

COME UP PROCEDURE
DESCRIBE THE FIRMS PROCEDURE TO BRING THE RETORT UP TO PROCESSING TEMPERATURE. INCLUDE TIME, TEMPERATURE, REMOVAL OF AIR FROM THE SYSTEM AND NUMBER OF STEPS:

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

No

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 .)

HEAT/TEMPERATURE DISTRIBUTION
HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED 0N THE FIRMS RETORTS? ....................... Yes FORM FDA 3511i (3/06) PAGE 4 No

Save As...

Print

Next Page

Previous Page

E-mail Form

Goto Page?

Reset Form

EXPLAIN AND PROVIDE COPIES OF SUPPORTING DOCUMENTS:

DATE OF LAST TEMPERATURE DISTRIBUTION STUDY:

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

No

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

No

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH CONTAINER TYPE (E.G. GLASS, METAL, PLASTIC)? .......................................................................................................................................................................... Yes No IF NO IDENTIFY THOSE WHICH WERE TESTED:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH INDIVIDUAL PRODUCT OR PRODUCT TYPE? E.G. SEAFOOD SOUP VERSUS CANNED TUNA? IF NO IDENTIFY THOSE TESTED. .............................................. Yes No

DID EACH TEMPERATURE DISTRIBUTION STUDY IDENTIFY A COLD SPOT IN THE RETORT? ........................... Yes PROVIDE LOCATION AND EXPLAIN:

No

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 LOW WATER FLOW? Yes REPORT RESULTS: No N/A

ARE PARTIAL LOADS PROCESSED IN THE FIRMS RETORTS? ................................................................................. Yes

No

ARE BAFFLE PLATES OR DUMMY LOADS USED DURING THE PROCESSING OF PARTIAL LOADS? ................. Yes EXPLAIN:

No

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED WITH PARTIAL LOADS? ............................ Yes

No

RETORT CRATES, RACKS
DESCRIBE THE RETORT CRATES. DIMENSIONS: NUMBER OF HOLES: SIZE OF HOLES: LOCATION OF HOLES: FORM FDA 3511i (3/06) PAGE 5

Save As...

Print

Next Page

Previous Page

E-mail Form

Goto Page?

Reset Form

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

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

ARE DIVIDER PLATES USED? ........................................................................................................................................ Yes DESCRIBE NUMBER OF HOLES AND DISTRIBUTION IN DIVIDER PLATES:

No

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

No

ARE CONTAINERS PROCESSED WITHOUT DIVIDER PLATES? ................................................................................ Yes DESCRIBE STACKING ARRANGEMENT (E.G. BRICK ,OFFSET, JUMBLE):

No

IS CONTAINER NESTING POSSIBLE ? .......................................................................................................................... Yes HOW DOES FIRM CONTROL NESTING OF CONTAINERS?

No

DOES THE FIRM PROCESS? Metal Cans .................... Yes Glass Jars .................... Yes Pouches .................... Yes Rigid Plastic .................... Yes No No No No

DOES THE FIRM PROCESS MORE THAN ONE CONTAINER SIZE? .......................................................................... Yes LIST ALL CONTAINER SIZES: METAL CANS ­ GLASS JARS ­ POUCHES ­ SEMI-RIGID PLASTIC ­ IF MORE THAN ONE CONTAINER SIZE OR TYPE IS PROCESSED AT ONE TIME, DESCRIBE PROCEDURE USED:

No

FOR RETORT POUCHES, ARE TRAYS ADEQUATELY DESIGNED WITH POCKETS SUFFICIENT TO CONTAIN AND RESTRAIN INDIVIDUAL POUCHES DURING COME-UP AND PROCESSING? .............................................................................. Yes No

ARE TRAYS OR DIVIDER PLATES IN GOOD CONDITION WITH NO SHARP OR ROUGH POINTS THAT COULD PUNCTURE CONTAINERS ? .................................................................................................................................................................. Yes No

PRESSURE CONTROL
ARE PRODUCTS PRODUCED USING OVERPRESSURE? .......................................................................................... Yes LIST THE OVERPRESSURES USED (E.G. 30 PSI AT 140 °C, 36 PSI AT 150 °C): No

FORM FDA 3511i (3/06)

PAGE 6

Save As...

Print

Previous Page

E-mail Form

Goto Page?

Reset Form

IS THE RETORT EQUIPPED WITH A PRESSURE GAUGE? ......................................................................................... Yes

No

DESCRIBE THE LOCATION WHERE COMPRESSED AIR ENTERS THE RETORT:

IS THE COMPRESSED AIR USED FOR OVERPRESSURE HEATED PRIOR TO INTRODUCTION INTO THE RETORT? Yes No

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

HAS THE POINT WHERE AIR ENTERS THE RETORT BEEN IDENTIFIED AS A COLD SPOT IN THE RETORT? ........ Yes

No

DESCRIBE HOW PRESSURE IS CONTROLLED IN THE RETORT DURING THERMAL PROCESSING:

HAS OVERPRESSURE BEEN IDENTIFIED AS A FACTOR CRITICAL TO THE THERMAL PROCESS? ................... Yes

No

ARE PRESSURE DROPS CONSIDERED TO BE PROCESS DEVIATIONS? ............................................................... Yes WHY? / WHY NOT?

No

CONTAINER COOLING
CONTAINERS ARE COOLED BY: ....................................................................................................................... Air EXPLAIN CONTAINER COOLING: Water

TYPE OF VALVE ON COOLING WATER LINES:

WERE COOLING WATER LINES NOTED TO BE LEAKING? ......................................................................................... Yes

No

DRAIN LINES
ARE SCREENS USED OVER ALL DRAIN LINES TO PREVENT CLOGGING? ........................................................... Yes No

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

No

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

FORM FDA 3511i (3/06)

PAGE 7