Form Preview Example

Firm Name, City & State:	FEI Number:
Inspection Date(s):	FCE Number:
Investigators:

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

PROCESSING IN CASCADING/SPRAY WATER 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 to the EIR as an exhibit. Measure and verify retort plumbing – record on this form. Report all pipe sizes as inside diameter (ID). Cross-sectional area = 3.14r2 (r = 1/2 diameter).

Cascading water retorts are covered by 113.40(j). These retorts must meet the requirements found in applicable sections of 113.40. The retorts and operating procedures must be carefully evaluated to ensure 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 cascading and spray water retort systems. Photographs are an excellent means of enhancing the description of a retort system.

Before entering the interior of the retort, you must confirm with the firm that you are following the firm’s Stan- dard Operating Procedures designed to meet OSHA confined space requirements. If the firm insists that only plant personnel enter the retort, witness the measurement procedure and data collection. To obtain OSHA con- fined space information and safety procedures, see the confined space presentation on the FDA ORAU web site. If the firm is not aware of the OSHA confined space requirements or does not have a confined space program,

DO NOT ENTER THE RETORT.

If problems are found with the firm’s retort equipment or processing system, refer the reader to the Turbo EIR for a narrative description of specific problems with supporting evidence, under “Objectionable Conditions and Management’s Response.” Submit the completed form as an EIR attachment.

RETORT DESCRIPTION

RETORT NO.

TYPE OF RETORT

Vertical Horizontal Other

LENGTH OR HEIGHT

DIAMETER

RETORT MANUFACTURER:

RETORT MODEL:

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

NUMBER OF BASKETS OR CRATES PER RETORT:

PROCESSING MODE	Static Still
COMMENTS:

Agitating

End-over-End Axial

Rocking

COMPUTER CONTROLS

DOES A COMPUTER CONTROL ANY OF THE RETORT FUNCTIONS?	Yes
EXPLAIN:

FORM FDA 3511g (1/11)

PAGE 1 of 11

PSC Publishing Services (301) 443-6740 EF

........................................................................................ Yes

Firm Name:	FEI Number:

DOES THE FIRM HAVE DOCUMENTATION ON HAND WHICH INDICATES THAT THE COMPUTER SYSTEM HAS BEEN VALIDATED?

EXPLAIN:

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

AGITATION

IS THE AGITATING RETORT OPERATED IN THE STILL MODE?	Yes
HAVE PROCESS ESTABLISHMENT TESTS DETERMINED THAT RETORT CRATE POSITION
IS CRITICAL TO THE COME-UP OR THERMAL PROCESS?	Yes
EXPLAIN:

WAS THE RECOMMENDED CRATE POSITION BEING USED DURING THE INSPECTION?

Yes

COMMENTS:

HOW DOES THE FIRM DETERMINE CRATE POSITION?

RETORT SPEED TIMING (113.40(e)(5))

IS THE ROTATIONAL SPEED OF THE RETORT SPECIFIED IN THE SCHEDULED PROCESS?

Yes

(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
(SHALL REQUIREMENT)
COMMENTS:

IS THE ROTATIONAL SPEED OF THE RETORT AND THE PROCESS TIME RECORDED FOR EACH RETORT LOAD PROCESSED?

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

IF NO TO THE ABOVE 2 QUESTIONS, DOES THE FIRM MONITOR AND RECORD THE
RETORT SPEED AND PROCESS TIME OF EACH RETORT LOAD PROCESSED?	Yes
COMMENTS:

FORM FDA 3511g (1/11)

PAGE 2 of 11

Firm Name:	FEI Number:

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

(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:

PROCESSING WATER

METHOD USED TO HEAT PROCESS WATER:

A. Steam Injection into Process Water

B. Heat Exchanger

IF OTHER, EXPLAIN:

C. Steam Spreader

D. Other

WATER DRAINS

ARE SCREENS USED OVER ALL DRAIN OPENINGS TO PREVENT CLOGGING OF DRAINS?	Yes
COMMENTS:

IS THE DRAIN LINE VALVE WATER TIGHT AND NON-CLOGGING?

Yes

COMMENTS:

WATER DISTRIBUTION

WATER DISTRIBUTION SYSTEM:
Manifold Plate?	Yes
Spray Nozzle Heads?	Yes
Manifold Pipe?	Yes
Other?	Yes
IF OTHER, EXPLAIN:

DESCRIBE HOLE SIZE AND DISTRIBUTION IN MANIFOLD/SPRAY NOZZLES:

HAVE HOLE SIZES BEEN ALTERED BY PRODUCT OR MINERAL BUILD-UP?	Yes
IF YES, DESCRIBE:

DOES FIRM HAVE A CLEANING PROGRAM FOR WATER DISTRIBUTION SYSTEM?	Yes
DESCRIBE:

HOW DOES THE FIRM ENSURE THAT WATER FLOW IS CONSTANT?

A...	Visual Checks	Yes
B...	Water Flow Measurement	Yes
C...	Flow Meter	Yes

HOW OFTEN IS WATER FLOW CHECKED?

FORM FDA 3511g (1/11)

PAGE 3 of 11

Firm Name:

FEI Number:

WHAT IS THE WATER FLOW RATE?

DESCRIBE THE PROCEDURE TO ENSURE WATER FLOW IS MAINTAINED:

PROVIDE THE WATER FLOW METER, MODEL NUMBER AND LOCATION:

AT WHAT POINT DOES WATER ENTER THE RETORT DISTRIBUTION SYSTEM?

Back Top	Yes	No
Back Bottom	Yes	No
Front Top	Yes	No
Front Bottom	Yes	No
Center	Yes	No
Multiple	Yes	No
EXPLAIN WATER DISTRIBUTION SYSTEM:

DESCRIBE WATER RETURN SYSTEM:

ARE WATER RETURN INLETS SCREENED?	Yes
COMMENTS:

IS THE PROCESSING WATER REUSED?	Yes
COMMENTS:

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

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:

ARE WATER FLOW PROBLEMS HANDLED AS PROCESS DEVIATIONS?	Yes
EXPLAIN:

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

COOLING WATER SUPPLY

IS PROCESSING WATER USED TO COOL CONTAINERS DURING THE COOLING CYCLE?	Yes
EXPLAIN HOW COOLING WATER IS INTRODUCED INTO THE SYSTEM:

FORM FDA 3511g (1/11)

PAGE 4 of 11

Firm Name:	FEI Number:

IF WATER IS INTRODUCED FROM AN EXTERIOR SOURCE DURING COOLING, IS THE WATER COOLING
LINE EQUIPPED WITH A CHECK VALVE?	Yes
COMMENTS:

MIG THERMOMETER/TEMPERATURE INDICATOR

IS THE RETORT EQUIPPED WITH A MERCURY-IN-GLASS (MIG) THERMOMETER?	Yes
COMMENTS:

IS A MIG THERMOMETER USED AS THE REFERENCE INSTRUMENT DURING PROCESSING?............................. Yes

COMMENTS:

IS THE RETORT EQUIPPED WITH ANOTHER TYPE OF TEMPERATURE INDICATOR DEVICE? ............................. Yes

IF SO, DESCRIBE THE INDICATOR:


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 PER INCH
(4°C PER CM) OF GRADUATED SCALE – 113.40(a)(1). ALSO, SEE LACF GUIDE , P. 14.)

COMMENTS:

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:

NAME AND TITLE OF PERSON WHO PERFORMED TEST:

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

Yes

COMMENTS:

DESCRIBE THE FIRM’S ACTIONS REGARDING MIG THERMOMETERS/TEMPERATURE INDICATORS THAT WERE OUT OF CALIBRATION:

IS THE MIG THERMOMETER MERCURY UNDIVIDED?

Yes

(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:

FORM FDA 3511g (1/11)

PAGE 5 of 11

Firm Name:	FEI Number:

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:

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

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. HOW DOES THE FIRM ENSURE THAT THE TEMPERATURE INDICATED IS REPRESENTATIVE OF THE PROCESSING TEMPERATURE?

TEMPERATURE RECORDER

TYPE OF TEMPERATURE RECORDER

Round Circular Chart

COMMENTS:

Strip Chart

Other

DO THE CHART SPECIFICATIONS MEET THE REQUIREMENTS OF PART 113?

Yes

(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 GUIDE, PART 2.)

COMMENTS:

IS THE TEMPERATURE CHART ADJUSTED TO AGREE AS NEARLY AS POSSIBLE WITH BUT NOT HIGHER THAN	Yes
THE KNOWN ACCURATE MERCURY-IN-GLASS THERMOMETER DURING THE PROCESSING PERIOD?

(SHALL REQUIREMENT – 113.40(b)(2). NOTE ANY DIFFERENCE BETWEEN THE RECORDING THERMOMETER AND THE MIG/

INDICATING THERMOMETER AND WHICH READING IS HIGHER.)

COMMENTS:

IS THERE A MEANS OF PREVENTING UNAUTHORIZED ADJUSTMENTS?

Yes

(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 OF PREVENTING UNAUTHORIZED CHANGES – 113.40(b)(2).)

COMMENTS:

IS THE CHART DRIVE TIMING MECHANISM ACCURATE?	Yes
COMMENTS:

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

FORM FDA 3511g (1/11)

PAGE 6 of 11

Firm Name:

FEI Number:

THE TEMPERATURE RECORDER SENSING BULB IS INSTALLED IN THE

Retort Shell

EXPLAIN:

External Well

After the Heat Exchanger

Before the Heat Exchanger

TEMPERATURE CONTROLLER

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

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

COMMENTS:

DURING THE INSPECTION, WAS THERE ANY EVIDENCE OF TEMPERATURE DROPS?

Yes

EXPLAIN:

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
COMMENTS:

DOES THE FIRM IDENTIFY PROCESS COME-UP STEPS AS CRITICAL ON THE PROCESSING FILING FORMS? ....Yes

(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.)

COMMENTS:

FORM FDA 3511g (1/11)

PAGE 7 of 11

Firm Name:

FEI Number:

RETORT PLUMBING AND EQUIPMENT ISSUES

WHEN WAS THE LAST MAJOR OVERHAUL OR MAINTENANCE PERFORMED ON THE RETORTS?

COMMENTS:

DOES THE FIRM CONDUCT A RETORT SURVEY PERIODICALLY (YEARLY), OR AFTER A MAJOR RETORT
OVERHAUL OR AFTER MAINTENANCE IS PERFORMED ON CRITICAL EQUIPMENT (RETORTS, FILLER,
BOILER CONFIGURATION, ETC.)?	Yes

A RETORT SURVEY IS NOT REQUIRED BY THE REGULATIONS, BUT IS COMMONLY USED TO DOCUMENT THAT A FIRM’S PROCESSING SYSTEM IS IN COMPLIANCE WITH FDA REGULATIONS AND THAT THE SYSTEM MEETS THE SAME CRITERIA (VALVE TYPE, STEAM SPREADER CONFIGURATION, ETC.) AS WHEN TEMPERATURE DISTRIBUTION STUDIES WERE CONDUCTED.

COMMENTS:

DO THE BOILERS SUPPLY SUFFICIENT STEAM TO THE RETORTS?	Yes
IS THERE SUFFICIENT PRESSURE IN THE HEADER PIPE SUPPLYING STEAM TO THE RETORTS,
ESPECIALLY WHEN MORE THAN ONE RETORT IS BEING VENTED SIMULTANEOUSLY?	Yes

COMMENTS:

TEMPERATURE DISTRIBUTION

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED ON THE FIRM’S RETORTS?

Yes

IF SO, WHO CONDUCTED THE STUDY, WHAT PROCEDURES WERE FOLLOWED AND WHO EVALUATED THE DATA?

IS THERE DOCUMENTATION SUCH AS A RETORT DIAGRAM AND PARAMETERS
USED TO VALIDATE THE TESTS?	Yes

(FOR AN EXPLANATION OF TEMPERATURE DISTRIBUTION, SEE P. 21 OF LACF GUIDE, PART 2. SPECIAL CONSIDERATIONS FOR CONDUCTING TEMPERATURE DISTRIBUTION STUDIES IN STEAM-AIR RETORTS ARE LISTED IN FORM 3511(h).)

COMMENTS:

DATE OF LAST TEMPERATURE DISTRIBUTION STUDY:

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

Yes

COMMENTS:

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

Yes

COMMENTS:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH	Yes
CONTAINER TYPE (E.G., GLASS, METAL, PLASTIC)?
COMMENTS:

FORM FDA 3511g (1/11)

PAGE 8 of 11

Firm Name:

FEI Number:

HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH INDIVIDUAL
PRODUCT OR PRODUCT TYPE (E.G., SEAFOOD SOUP VERSUS CANNED TUNA)?	Yes
COMMENTS:

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

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE
THE EFFECTS OF TEMPERATURE DROPS DURING COME-UP AND PROCESSING?	Yes
REPORT RESULTS:

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED TO DETERMINE
THE EFFECTS OF LOW WATER FLOW?	Yes
REPORT RESULTS:

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

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

HAVE TEMPERATURE DISTRIBUTION STUDIES BEEN PERFORMED WITH PARTIAL LOADS?

Yes

COMMENTS:

HAVE THERE BEEN ANY CHANGES TO THE RETORTS OR THERMAL PROCESSING SYSTEM SINCE THE
LAST TEMPERATURE DISTRIBUTION STUDY THAT COULD AFFECT TEMPERATURE DISTRIBUTION?	Yes

(THE RETORT DESIGN, LOADING CONFIGURATION, SMALLEST CONTAINER SIZE AND MANY OTHER FACTORS CAN AFFECT THE ATTAINMENT OF TEMPERATURE DISTRIBUTION IN THE RETORT – SEE PP. 21-22 OF LACF GUIDE, PART 2. A CHANGE IN ANY OF THESE FACTORS COULD NECESSITATE A NEW TEMPERATURE DISTRIBUTION STUDY AND POSSIBLY A NEW VENT SCHEDULE.

IF A CHANGE HAS BEEN MADE IN THE THERMAL PROCESSING SYSTEM THAT COULD AFFECT TEMPERATURE DISTRIBUTION, THE FIRM SHOULD HAVE ON FILE DOCUMENTATION OF THE CHANGE, INCLUDING THE REVIEW AND APPROVAL BY A QUALIFIED PROCESS AUTHORITY.)

COMMENTS

RETORT CRATES AND RACKS

DESCRIBE THE RETORT CRATES.

DIMENSIONS:

NUMBER OF HOLES:

SIZE OF HOLES:

LOCATION OF HOLES:

FORM FDA 3511g (1/11)

PAGE 9 of 11

Firm Name:	FEI Number:

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

ARE DIVIDERS, TRAYS, RACKS OR OTHER MEANS OF POSITIONING FLEXIBLE CONTAINERS DESIGNED

AND EMPLOYED TO ENSURE EVEN CIRCULATION OF HEATING MEDIUM AROUND ALL CONTAINERS? ........... Yes

COMMENTS:

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

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

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

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

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

DOES THE FIRM PROCESS?
Metal Cans	Yes
Glass Jars	Yes
Pouches	Yes
Rigid Plastic	Yes
COMMENTS:

No No

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 PROCEDURE USED:

FORM FDA 3511g (1/11)

PAGE 10 of 11

................................................................................ Yes

Firm Name:	FEI Number:

FOR POUCHES, ARE TRAYS ADEQUATELY DESIGNED WITH POCKETS TO CONTAIN
AND RESTRAIN INDIVIDUAL POUCHES DURING PROCESSING?	Yes
...............................................................................	Yes
COMMENTS:

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

COMMENTS:

PRESSURE CONTROL

ARE PRODUCTS PRODUCED USING OVER-PRESSURE?	Yes
............................................................................................	Yes
LIST THE OVER-PRESSURES USED (E.G., 30 PSI AT 140°C, 36 PSI AT 150°C):

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

COMMENTS:

DESCRIBE THE LOCATION WHERE COMPRESSED AIR ENTERS THE RETORT:

IS THE COMPRESSED AIR USED FOR OVER-PRESSURE HEATED PRIOR
TO INTRODUCTION INTO THE RETORT?	Yes
COMMENTS:

IS A DIFFUSER USED ON THE COMPRESSED AIR ENTRY LINE TO ENSURE RAPID MIXING
OF THE AIR IN THE RETORT ATMOSPHERE?	Yes
COMMENTS:

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

EXPLAIN HOW PRESSURE IS CONTROLLED IN THE RETORT:

HAS OVER-PRESSURE BEEN IDENTIFIED AS CRITICAL TO THE THERMAL PROCESS?

Yes

COMMENTS:

ARE PRESSURE DROPS CONSIDERED TO BE PROCESS DEVIATIONS?

Yes

COMMENTS:

OTHER CONCERNS AND OBSERVATIONS

PLEASE EXPLAIN OTHER CONCERNS NOTED REGARDING THERMAL PROCESSING IN THIS FIRM:

FORM FDA 3511g (1/11)

PAGE 11 of 11

Question	Answer
Form Name	Form Fda 3511G
Form Length	11 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	2 min 45 sec
Other names	OSHA, GPM, LACF, FDA

Form Fda 3511G – Fill Out and Use This PDF

Form Fda 3511G PDF Details

Form Preview Example

Form Fda 3511G isn’t the one you’re looking for?

Form Fda 3511G – Fill Out and Use This PDF

Form Fda 3511G PDF Details

Form Preview Example

Form Fda 3511G isn’t the one you’re looking for?

Related Documents