U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition

Aseptic Packaging System Supplement
to
What You Need to Know about Establishment Registration and Process Filing for Acidified and Low-acid Canned Foods

NOTE: THIS SUPPLEMENT CONTAINS INSTRUCTIONS FOR FILING PROCESSES FOR ASEPTIC PACKAGING SYSTEMS. ALL USERS SHOULD BECOME THOROUGHLY FAMILIAR WITH APPLICABLE REGULATIONS FOR REGISTRATION AND PROCESS FILING AND WITH THE GENERAL INSTRUCTIONS IN THE MAIN INSTRUCTION BOOKLET. IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT THE LACF REGISTRATION COORDINATOR AT (301) 436-2411 OR BY ELECTRONIC MAIL AT LACF@CFSAN.FDA.GOV

SEE THE MAIN INSTRUCTION BOOKLET FOR COMMON QUESTIONS AND ANSWERS CONCERNING REGISTRATION AND PROCESS FILING; GLOSSARY OF TERMS; METRIC TO ENGLISH CONVERSION CHART; AND CELSIUS TO FAHRENHEIT TEMPERATURE CONVERSION CHART.

Use Form FDA 2541c for filing processes for aseptic packaging systems only for LACF products under 21 CFR 108.35. Use Form FDA 2541a for all other processing methods, including acidified products filed under 21 CFR 108.25. For acidified LACF products packaged by aseptic packaging systems, the factor which provides the public health protection (heat or acidification) determines which form is to be used (i.e., for a product acidified to a maximum equilibrium pH #4.6, use Form FDA 2541a.

Complete each required block on the form in English according to the following instructions. Unless otherwise indicated, all blocks on the form must be completed, regardless of whether this is a new submission or a replacement for a previously submitted one. The paragraph numbers below correspond to the numbered blocks on the sample form on page 15. See pages 7-8 in Section I of the main instruction booklet for a complete explanation of the submission identified (SID).

1. FCE

   Enter the 5-digit Food Canning Establishment (FCE) number assigned to your establishment by the FDA when you registered (on Form FDA 2541). If registering concurrently with initial process filing, leave blank (FDA will complete). Upon receipt of your FCE number from FDA, record it on your copies of the process filing forms.

2. Establishment Name and Location Address

   Enter the name of your plant and the plant location address corresponding to the FCE Number entered in 1. This is used by FDA as a check of the FCE number and may not be used to change the name or address. Name and address changes must be submitted on an Establishment Registration form (FDA 2541).

   An address change resulting from a move to a different location (as opposed to a street name change, etc.) requires re-registration, assignment of a new FCE number, and re-filing of all scheduled processes. The old FCE number is not valid and its use will not be accepted by FDA.

   U.S. Firms:

   Enter the two-letter abbreviation for your state or territory; leave "country" block blank.

   Foreign Firms:

   For "state", enter the name or abbreviation of the province or other subdivision of your country (if applicable). Otherwise, leave blank.

   For "ZIP Code", enter the postal code established by the postal system of your country, if one has been established. Otherwise, leave blank.

   Enter the name of the country in which your establishment is located.

3. Submission Identifier (SID)

   Assign a unique SID to each process filing form, in the format YY-MM-DD/SSS based on when you are submitting the form, where:

   YY the last two digits of the year (e.g., 99, 01, 02, etc.)

   MM is the numerical designation of the month (e.g., 05 for May, 10 for October etc.)

   DD is the day of the month (e.g., 03, 28, etc.)

   SSS is a unique sequence number within the date (e.g., 001, 002, etc.)

   SEE PAGES 7-8 IN SECTION I OF THE MAIN INSTRUCTION BOOKLET FOR COMPLETE EXPLANATION OF SUBMISSION IDENTIFIER (SID).

4. New, Replacement, or Cancellation

   If this is a new submission of a process for a low-acid canned food product (no previous processes filed for this product in the container sizes listed), check "new" and complete the remaining blocks.

   If this is a replacement for a previously submitted process filing form, check "replaces", followed by the SID of the MOST RECENT SUBMISSION WHICH IS BEING REPLACED and complete the remaining blocks.

   If this is a cancellation of a previously submitted process filing form which is not being replaced by another, check "cancels", followed by the SID of the previous submission which is being canceled. To help ensure that the correct process is being canceled, enter the food product name as instructed in 7 on the next page. Sign and date the form as instructed in 22 and submit it to FDA.

   As an alternative, you may photocopy the form to be canceled. Assign a new SID in 3 (lining out the original one without making it unreadable), and check "cancels" in 4 followed by the SID being canceled. Sign and date the photocopy below the original signature and date and submit it to FDA. Computer printed forms may be submitted as long as these reproductions closely emulate FDA’s 2541c.

5. Scheduled or Alternate

   Check "scheduled" if this is the ordinarily used process for this product under normal conditions.

   If this is a process used regularly in lieu of the ordinarily used (scheduled) process (which is filed separately), check "alternate for" and enter the SID of the scheduled process for which this is an alternate.

   NOTE: Alternate processes should be reported ONLY WHEN THEY ARE USED REGULARLY. Otherwise, they need not be filed.

   If you are replacing a scheduled process for which you have filed alternate processes, FDA will assume that the alternate processes apply to the replacement scheduled process as filed. If the alternate processes do not apply to the replacement, they should be replaced or canceled by separate submissions.

   Additional Container Sizes

   Additional container sizes for a previously submitted food product must be reported separately as a NEW or REPLACEMENT SUBMISSION, even if all other information is the same.

   Deletion of Containers Size(s)

   Submit a "REPLACEMENT" for the originally filed form as instructed above, leaving off the container sizes that are no longer applicable. You may reproduce the original form, if desired, entering the additionally required information for a replacement form as indicated above, lining out the inapplicable container size(s), and signing and dating the form (below the original signature). Assign a unique new SID to the REPLACEMENT form clearly indicate the previous submission being replaced by entering its SID in 4.

   Forms Returned by FDA for Missing Data

   When resubmitting a form which had been returned by FDA for missing data, enter the missing data directly on the returned form (unless otherwise instructed) and send it to FDA. DO NOT CHANGE TYPE OF SUBMISSION OR THE SID. Be sure to enter the missing data on your file copy of the form.

   If it is necessary to complete a new form to furnish the missing data, complete blocks 1 through 6 exactly as originally submitted. Complete all other blocks, entering ALL information specified below. Attach the form which had been returned and mail them both to FDA.

6. SUP SID:

   Enter the SID of the supplemental information which applies to this process filing form (see "REQUIRED SUPPLEMENTAL INFORMATION" on page 11). For example: SUP SID: 01-04-22/015

7. Food Product Name, Form or Style, and Packing Medium

   Enter the food product name, form or style, and packing medium, in that order, e.g., whole milk; butterscotch pudding; split pea soup (condensed); etc. A separate form must be used for each product form or style (strained, ready-to-eat, high fat, paste, dry ingredient, etc.) which receives a different scheduled process OR when the characteristics of the food affect heat transfer or affect microbial heat resistance.

   Product forms or styles receiving the same scheduled process should be included parenthetically after the product name.

   A separate form is not required for each different brand name of a product so long as the scheduled process for all brands is exactly the same.

   Foreign Firms

   List the English name as well as the non-English name as it appears on the label. For example:

   Whole milk (lait)

8. Name of the Product Sterilizer

   In the upper portion of the block, enter the name of the manufacturer, the type of sterilizer, and the model number or name (if applicable). Limit to 30 characters when possible. Abbreviations may be used when meanings are clear. For example:

   Cherry Burrell: Swept Surf Ht Ex

   Name of Packaging Sterilizer

   In the lower portion of the block, enter the name and type of packaging system used and the model number or name (if applicable). For example:

   Dole: Superheated Steam

9. Process Origin

   Source

   Enter the name of the process authority (organization, company, or individual, etc.) which conducted the scientific studies establishing the scheduled processes(es) listed on the form, and the type of document in which published (i.e., letter, bulletin, etc.). List the source for the product sterilizing process in the upper portion of the block and the source for the packaging sterilizer process in the lower portion. Use the following guidelines in making entries for process source.

   • When possible, limit entries to 30 characters for each source by minimizing punctuation, not using plurals, etc.

   • If a process is established as a result of your own firm's studies, enter your firm's name as the source.

   • When processes have been established jointly, list both process sources. For example:

     Source	Year and Month
     ABC/EFG	2001-01
     Ready Pack/Tech T	1995-06

   • For universities, enter name of university followed by the name of an individual (if appropriate).

   Date

   Enter the year (e.g., 1995, 2002, etc.) and the numeric designation of the month (e.g., 05 for May, 11 for November, etc.) of the latest source document issued by the qualified process authority which established or modified the process used. List date applicable to product sterilizer in the upper portion of the block and the date applicable to the packaging sterilizer in the lower portion.

10. Container Type

    Except for tinplate/steel and aluminum cans (which may be submitted on the same form if the processes are identical), USE A SEPARATE FILING FORM FOR EACH DIFFERENT CONTAINER TYPE EVEN IF ALL OTHER INFORMATION IS THE SAME.

    Check the container type used. If a container type other than those listed is used, check "4. other" and describe on the following line or in “22. comments”. specifying the material from which constructed). For example:

    Pouch (polyethylene/alum. foil laminate)

    Semi-rigid Container (e.g., cups, tubs, cartons, etc., - describe and specify material from which constructed)

    NOTE: Minor container material variations which do not affect the scheduled process do not require submission of separate forms.

11. Maximum Water Activity

    Enter value to the nearest hundredth (e.g., .88) ONLY IF REDUCED WATER ACTIVITY IS CRITICAL TO THE DELIVERY OF THE SCHEDULED PROCESS as specified by the process source cited in 9. Otherwise, enter N/A. IF THIS BLOCK IS COMPLETED, WATER ACTIVITY MUST BE CONTROLLED DURING PROCESSING AND RECORDS OF THE MEASUREMENTS MUST BE KEPT.

12. pH

    Normal

    Enter normal or natural pH of the product before processing, to the nearest tenth (e.g., 5.1).

    Maximum

    For products packaged by aseptic packaging systems were pH control is specified by the process source as a critical factor, enter the maximum equilibrium pH (upper limit) of the finished product after acidification, measured within 24 hours after processing to the nearest tenth (e.g., 4.7).

13. Maximum Consistency or Viscosity

    Enter consistency or viscosity data as follows, ONLY IF CRITICAL TO THE DELIVERY OF THE SCHEDULED PROCESS as specified by the process source cited in 9.

    Value at 77+/-2 degrees F

    If consistency or viscosity is not applicable, enter N/A. If consistency is specified by the process source to be measured at

    77± 2°F, enter the maximum consistency reading at that temperature, measured to the nearest thousandth (e.g., 3,000). If consistency is given by the process source as a range, report the highest value.

    Value at other temp

    If consistency is specified by the process source to be measured at another temperature, enter the maximum consistency reading at that temperature, measured to the nearest thousandth (e.g., 50,000). If consistency is given by the process source as a range, report the highest value.

    Other temp

    Enter the temperature (other than 77°) at which reading is taken, to the nearest whole degree (e.g., 160)(±2°F is assumed). If temperature is specified by the process source as a range, you may report that range.

    Units

    Enter units in which reading is measured. Abbreviate to 3 characters. For example:

    CPS - centipoise

    C/S - centimeters/second

    INS - inches

    Method Name

    Enter instrument used and its characteristics. Limit to 30 characters, if possible. If Brabender is used, include the paddle (e.g., Brabender A Paddle).

    IF THIS BLOCK IS COMPLETED, CONSISTENCY MUST BE CONTROLLED DURING PROCESSING AND RECORDS OF THE MEASUREMENTS MUST BE KEPT.

    Product Viscosity Characteristic

    In the block preceding 14 (Specific Gravity), enter the viscosity characteristic of the product as follows:

    Enter N for Newtonian.

    Enter P for pseudoplastic.

    Enter D for dilatant.

    The product viscosity characteristic can be determined in the following ways:

    • From handbooks (for example, Charm, S.E., 1971, The AVI Publishing Co., Westport, Conn., p. 64)

    • From technical literature (for example, Scalzo, et al., 1970; Food Technology, 24(11):113);

    • By direct measurement as follows:

      Measure viscosity at constant temperature and three rates of shear.

      - If viscosity decreases with increased rates of shear, the fluid is pseudoplastic (flow-thinning);

      - If viscosity increases with increased rates of shear, the fluid is dilatant (flow-thickening).

14. Specific Gravity

    Enter the specific gravity of the food product measured at 77±2°F. Express to the nearest thousandth (e.g., 1.101).

15. Inside Diameter of Holding Tube

    Express in inches, to the nearest hundredth (e.g., 1.37)

16. Holding Tube Length

    Express to the nearest whole inch (e.g., 480).

17. Other Critical Factors

    Enter other critical factors as SPECIFIED BY THE PROCESS SOURCE WHICH MUST BE CONTROLLED IN ORDER TO ASSURE DELIVERY OF THE SCHEDULED PROCESS. Check all blocks which apply AND, where applicable, enter the appropriate value. For example:

    • If "Percent solids" is checked, enter the percentage (e.g., 80%) in “22 Comments”)

    • If "Ratio of solids to liquids" is checked, enter the ratio (wt. to wt.) to the nearest hundredth (e.g., 1.55) in “22 Comments”;

    • If "Syrup" strength" is checked, enter maximum degrees (Brix) to the nearest whole degree in “22 Comments”.

    • Particle size (shape, dimension, thickness, etc.)

    TO ENTER VALUES: check 73 (OTHER) enter the number of the applicable factor, and the value. For example:62=1.55.

    For critical factors not listed, check "other", and enter the factor and critical value (if applicable). For example:

    • pH controlled (specify maximum finished equilibrium value in 12)

    • Process based on inoculated pack

18. Container Dimensions

    Enter the dimensions of each container size which is used for the product IN ENGLISH UNITS. Use a separate line for each different container size and its process parameters or characteristics. DO NOT LEAVE BLANK LINES BETWEEN CONTAINER SIZES. List container dimensions in inches and sixteenths of an inch as described below, using 4 digits (for example, 0301 for a 3 1/16 inch dimension). See Appendix A in the main instruction booklet for metric to English conversion table.

    Cylindrical Containers

    Enter the diameter in the first column and height in the second. Leave the third column blank.

    Rectangular Containers

    Enter length (longest dimension) in the first column, width (second longest dimension) in the second, and height in the third.

    Pouches

    Enter the length (longest dimension, excluding heat seal) in the first column, width (second longest dimension, excluding heat seal) in the second column, and maximum thickness in the third. See illustration below:

    Unconventional or Irregular Shaped Containers

    When the specified dimensions cannot be used, cross out "hgt" in third column and enter the English units (fluid oz., gal., etc.). Enter the container volumetric capacity.

19. Scheduled Process

    For each container size identified in 18, enter the scheduled process informaiton specified by the process source cited in 9 as follows:

    Minimum Initial Temperature

    If not applicable, enter N/A. Enter temperature of the coldest product to be processed at the time the sterilizing begins. Express (in degrees F) to the nearest whole degree (e.g., 180). This factor is often critical for products heated by steam infusion or steam injection or for product containing discrete particles.

    Process Time

    Enter minimum process time IN SECONDS to the nearest hundredth (e.g., 27.00).

    Processing Temperature

    Enter minimum processing temperature (measured at the holding tube outlet) in whole degrees (°F)(e.g., 275). NEVER ROUND UP (e.g., 275.9 is reported as 275).

    Least Sterilizing Value

    Express F_° to the nearest tenth of a minute (e.g., 7.0). If other than F_° is applicable, enter value for F and specify (below the last value) the death rate (z) and reference temperature (T) in whole degrees F. For example, z=16; T=240.

    If other equivalent scientific basis for process adequacy is applicable (for example, Integrated Sterilizing Value (IS)), specify to the right of the value.

    Flow Correction Value

    This value represents the correction for laminar e.g., 2.0 or turbulent (e.g., 1.2) flow of the fastest particle. The value can be based on scientific studies (if done, attach the report)

20. Maximum Food Flow Rate

    Express in gallons per minute where measured, to the nearest hundredth of a gallon (e.g., 18.40). If given in units other than gallons (e.g., lbs., per minute), line out "gal/min" and specify units above the heading for this column.

21. Thruput

    Enter the maximum thruput allowable, as specified by the process source, expressed in whole containers per minute (e.g., 500).

22. Comments

    Where necessary, enter specific information here or refer to an attachment. For steam injection or infusion heating requiring flow correction when flow rate is measured prior to heating, enter both correction factors. If flow rate is measured after steam injection or steam infusion heating, enter a comment.

23. Authorized Company Representative

    Enter the name, title, and signature of the authorized representative who is signing this form on behalf of the company and the telephone number (including area code) at which she or he can be reached. Date the form and mail the original (white) copy to:

    LACF Registration Coordinator (HFF-618)
    Food and Drug Administraton
    5100 Paint Branch Parkway
    College Park, MD 20740-3835

    Keep the second (pink) copy for your files. You are required to maintain a file copy for future reference at the processing plant location.

REMINDER: A glossary of terms; Metric to English conversion chart; Celsius to Fahrenheit temperature conversion chart; and common questions and answers concerning registration and process filing are contained in the main instruction booklet to which this supplement applies.

Supply the following supplemental information on a separate sheet (or sheets) in two copies. Number each item to correspond to the numbers and letters below. Assign a unique SID according to the instructions in 3 on page 2, entering it at the top left of each sheet following the FCE number. For example:

FCE #04999
SUP SID: 01-02-20/011

If this supplemental data replaces a previous submission, identify the replaced submission in parentheses immediately following. For example:

FCE#04999
SUP SID: 01-02-20/011 (replaces 97-04-22/015)

Immediately below, enter the SID of all current processes to which the supplemental information applies. For example:

Applies to: 94-02-12/003, 004, 005; 97-09-15/001, 002, 003; 01-01-03/002; 01-02-02/001, 002, 003; 02-02-30/007

Each unique set of supplemental information must be submitted only once. Each subsequent process filing form submitted to which the supplemental information applies must include the above mentioned supplemental data Sid (SUP SID) following the "Type of Submission" data (see 6 on page 5).

PRODUCT STERILIZER

1. Sterilizing medium used during start-up to sterilize the product sterilizer and all product contact surfaces downstream from the holding tube in the sterilizing system (e.g., steam, water, other medium specified by the process source).

2. Minimum sterilizing temperature used during start-up to sterilize the product sterilizer and all product contact surfaces downstream from the holding tube in the sterilizing system. Express in °F to the nearest whole degree.

3. Minimum time that the sterilizing medium must be recirculated through the sterilizer to achieve a sterile condition in the sterilizer (in minutes).

4. Minimum back pressure required at a specific location in the sterilizer to prevent flashing of water to steam (and hence, a reduced holding time in the holding tube). Specify minimum back pressure in pounds per square inch gauge (psig) and location of measurement.

SPECIFICATIONS TO ACHIEVE AND/OR MAINTAIN (AS INDICATED) COMMERCIAL STERILITY OF SPECIFIED EQUIPMENT AND/OR AREAS

		(a)	(b)	(c)	(d)
		Achieve and Maintain		Filing Area	Closing Area
		Containers	Lids	Maintain	Maintain
10.	Sterilizing Medium used
11.	Minimum temperature of sterilizing medium
12.	Minimum concentration of sterilizing medium (if chemical)			N/A	N/A
13.	Minimum exposure time			N/A	N/A
OR
14.	Maximum Conveyor Speed			N/A	N/A
15.	FOR STERILIZING GASES ONLY Minimum Gas flow rate through chamber			N/A	N/A
OR
16.	Minimum gas pressure required in chamber			N/A	N/A

17. If filters are used to obtain sterile air supply for the filling and closing areas, specify the maximum operating time interval and or sterilization cycles permitted between filter changes.

The information requested in 5. through 16. May be submitted either in a list or a tabular form as in the following examples:

List Form

5. (a) Steam
   (b) Steam
   (c) etc.
   (d) ...
   (e) ...
   (f) ...
   

6. (a) 260
   (b) etc.
     ...
     ...
   

16. (a) ...
    (b) ...
      ...

Tabular Form

Enter the name, title, telephone number (including area code) and signature of the authorized representative who is submitting this information on behalf of the company (and the date signed) at the bottom of the last supplemental page. Mail two copies to:

LACF Registration Coordinator (HFS-618)
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740-3835

KEEP ONE COPY FOR YOUR FILES. You are required to maintain a file copy for future reference at the processing plant location.

NOTE: These instructions are not all-inclusive, particularly for new systems. FDA expects a copy of the process validation report and information on the new systems not previously filed with FDA. Therefore, any additional information, critical factors, and/or controls which are specified by the process source (although not specifically addressed above) must also be provided.

Hypertext updated by ear 2002-FEB-05