Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541d

Instructions for Paper Submission of
Form FDA 2541d (Food Process Filing
for Low-Acid Retorted Method)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Month Year

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Table of Contents
I.

Introduction ................................................................................................................. 6

II. How to Submit Process Filing Form FDA 2541d by Paper .......................................... 7
A. General Information ............................................................................................ 7
B. Step 1: Top of Form – Food Canning Establishment Number and Submission
Identifier ...................................................................................................................... 9
1. Food Canning Establishment (FCE) Number: ................................................. 9
2. Submission Identifier (SID): ............................................................................ 9
C. Step 2 – Section A. Product Information ........................................................... 10
1. Food Product Group (Optional): .................................................................... 10
2. Enter Product Name. ...................................................................................... 10
3. What is the form of the product? .................................................................... 11
4. What is the packing medium? ........................................................................ 11
D. Step 3 – Section B. Governing Regulation........................................................ 11
E. Step 4 – Section C. Container Type ................................................................... 12
1. Aluminum/Tinplate/Steel Can........................................................................ 12
2. Ceramic/Glass ................................................................................................ 13
3. Flexible Pouch ................................................................................................ 14
4. Retortable Paperboard Carton ........................................................................ 15
5. Semi-Rigid ..................................................................................................... 17
6. Other Container .............................................................................................. 19
F. Step 5 – Section D. Container Size .................................................................... 19
1. Dimensions:.................................................................................................... 20
2. Net Weight (Optional):................................................................................... 20

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G. Step 6 – Section E. Processing Method: Thermally Processed Non-Aseptic
System ....................................................................................................................... 21
1. What is the finished equilibrium pH of the product after processing?........... 21
2. Heating medium ............................................................................................. 21
H. Step 7 – Section F. Process Mode .................................................................... 22
1. Mode............................................................................................................... 22
2. Cooker: What type of cooker do you use? ..................................................... 23
I. Step 8 – Section G. Process System Critical Factors ......................................... 23
1. What is the filling method(s) used to fill the product into the container? ...... 23
2. How many phases are used to fill the container with the product? ................ 23
3. Is the product vacuum packed? ...................................................................... 24
4. What is the container position in the retort? .................................................. 24
5. Minimum Come-Up-Time ............................................................................. 24
6. Minimum Water Flow Rate ........................................................................... 25
J. Step 9 – Section H. Product Critical Factors ..................................................... 25
1. Does the product contain particulates?........................................................... 25
2. Does the product contain any dry ingredients? .............................................. 26
3. How are pieces arranged in the container?..................................................... 26
4. Does the % total solids affect the heating of the product during processing? 26
5. Is the finished equilibrium pH of the product after processing (identified in
Section E) critical to the process? ......................................................................... 27
6. Does consistency/viscosity affect the heating of the product? ....................... 27
7. Is starch added to maintain consistency/viscosity of the product?................. 27
8. Are other binders added?................................................................................ 28
9. Does syrup strength affect the heat penetration during processing of the
product?................................................................................................................. 28

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K. Step 10 – Section I. Process Source .................................................................. 29
1. Process Source: .............................................................................................. 29
2. What is the Manufacturer’s Name and the Sterilizer Model? ........................ 29
L. Step 11 – Section J. Scheduled Process ............................................................ 29
1. Column 1. Process No. .................................................................................. 30
2. Column 2. Step .............................................................................................. 30
3. Column 3. Minimum Initial Temperature ..................................................... 30
4. Column 4. Process Time ............................................................................... 30
5. Column 5. Process Temperature ................................................................... 31
6. Column 6. Fo (F18/250) ................................................................................ 31
7. Column 7. Thruput (Containers per Minute) ................................................ 31
8. Column 8. Headspace .................................................................................... 31
9. Column 9a. Reel Speed ................................................................................. 31
10. Column 9b. Reel Diameter .......................................................................... 32
11. Column 9c. Steps per Turn of the Reel ....................................................... 32
12. Column 9d. Chain / Conveyor Speed .......................................................... 32
13. Column 9e. Cooker Capacity ...................................................................... 32
14. Column 9f. Frequency Strokes per Minute (Oscillation Agitating ONLY) 32
15. Column 10. Maximum Fill Weight ............................................................. 32
16. Column 11. Minimum Free Liquid at Closing ............................................ 33
17. Column 12. Minimum Container Closing Machine Gauge Vacuum .......... 33
18. Column 13. Other ........................................................................................ 33
M. Step 12 – Section K. Additional Information (Optional) ................................ 33
1. Heat Penetration Data (Optional): ................................................................... 33
2. Comments: ..................................................................................................... 34

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3. Full Name, Signature, Establishment Name and Date ................................... 34
III. How to Contact FDA or Obtain Help ......................................................................... 35
IV.
V.

References ............................................................................................................. 35
Appendix ................................................................................................................... 35
A. Container Types and Shapes ............................................................................. 35
B. Container Dimension Measurements................................................................. 40
1. Cylindrical Measurement ............................................................................... 41
2. Oval Shape Measurement............................................................................... 41
3. Rectangular Shape, Rectangular Tray and Low-Profile Measurement .......... 42
4. Rectangular Shape Measurement ................................................................... 43
5. Rectangular Tray Measurement ..................................................................... 43
6. Low-Profile Measurement.............................................................................. 43
C. Abbreviations..................................................................................................... 43

Table of Figures
Figure 1 – Cylindrical Shape 2-Piece Aluminum Containers Depicting Double Seams .. 35
Figure 2 – Low-Profile Rectangular Shape 2-Piece Aluminum Containers ..................... 36
Figure 3 – Cylindrical Shape 3-Piece Steel Containers with a Double Seam and Side
Seam .................................................................................................................................. 36
Figure 4 – Cylindrical Shape 2-Piece Steel Containers with a Double Seam .................. 37
Figure 5 – Flexible Pouch ................................................................................................. 37
Figure 6 – Glass Containers .............................................................................................. 38
Figure 7 – Semi Rigid Body, Oval Shape Containers with Heat Seal .............................. 38
Figure 8 – Semi Rigid Body, Rectangle Shape Containers .............................................. 39
Figure 9 – Semi Rigid Body with an Aluminum Double Seam ....................................... 39
Figure 10 – Semi Rigid Body, Cylinder Shape Containers with Induction Weld Seal .... 40

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Figure 11 – Semi Rigid Body with Heat Seal ................................................................... 40
Figure 12 – Measurement of a Cylindrical Shape Container. ........................................... 41
Figure 13 – Measurement of an Unusual Shape Cylindrical Container. .......................... 41
Figure 14 – Measurement of an Oval Shape Container .................................................... 42
Figure 15 – Measurement of Outer Edges of Container ................................................... 42
Figure 16 – Measurement of a Rectangular Shape Container .......................................... 43
Figure 17 – Measurement of a Rectangular Tray Shape Container .................................. 43
Figure 18 – Measurement of a Low-Profile Container ..................................................... 43

I.

Introduction

This document is intended for:
•

Commercial processors who manufacture, process, or pack thermally processed
low-acid foods packaged in hermetically sealed containers (historically referred to
as “low-acid canned foods” or “LACF”) 1; and

•

Persons who are authorized to act on behalf of such commercial processors 2.

Commercial processors who manufacture, process, or pack LACF are subject to the
registration requirements of 21 CFR 108.35(c)(1), as well as the process filing
requirements of 21 CFR 108.35(c)(2). These provisions require two basic types of
submissions:
•
•

Food Canning Establishment Registration using Form FDA 2541; and
Process filings using the following forms:

1

Although some hermetically sealed containers (e.g., pouches and glass bottles) used to package thermally
processed low-acid foods generally would not be viewed as “cans,” the term “low-acid canned foods” has
been used for decades as a shorthand description for “thermally processed low-acid foods packaged in
hermetically sealed containers,” and we continue to use that term (and its abbreviation, LACF) for the
purposes of this document.
2

Individuals who are authorized to act on behalf of the commercial processors may do so for more than one
commercial processor. Reference 1 addresses our electronic system for submitting process filing and
identifies the responsibilities of each type of authorized user for that system.

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•
•

Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method)
Form FDA 2541f (Food Process Filing for Water Activity /Formulation Control
Method)
Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems)

This document provides detailed instructions on:
•
•

How to submit process filings by using a paper Form FDA 2541d (Food Process
Filing for Low-Acid Retorted Method).
Form FDA 2541d is intended for low-acid food products where the growth of
microorganisms is controlled through the application of heat to foods.

This document does not provide:
•
•
•
•

Instructions for electronic submission of Form FDA 2541d (Food Process Filing for
Low-Acid Retorted Method);
Instructions for submitting process filing Forms FDA 2541f, and FDA 2541g in either
electronic or paper format;
Instructions for submitting Form FDA 2541e (Acidified Foods) in either electronic or
paper format; or
Instructions for submitting plant registration Form FDA 2541 in either electronic or
paper format.

For additional information about registration and process filing for commercial
processors of LACF, see our guidance entitled “Guidance for Industry: Submitting Form
FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA
2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or
Paper Format” (Ref. 1 and the appendices in Reference 1.) For a list of abbreviations
used in this document, refer to Appendix C.

II. How to Submit Process Filing Form FDA 2541d by
Paper
A.

General Information

The paper Form FDA 2541d contains 11 sections (Sections A through K).
•

•

All mandatory fields on Form FDA 2541d must be completed. Only three sections
include optional information:
• Section A, Question 1 (Food Product Group) is optional.
• Section D, Question 2 (Net Weight (Optional)) is optional.
• Section K, Additional Information (Optional) is optional.
When you manufacture, process, or pack a product in more than one container size or
type, you are required to submit a separate Form FDA 2541d for each container size
and type.

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•

•

•

•

You may report multiple forms of the product (e.g., diced, chunks, cut, fillet) on the
same Form FDA 2541d, provided that:
• Other factors (e.g., container type or size) do not require separate filing; and;
• The process information you provide in Section J of Form FDA 2541d applies to
each product variation. If the heat transfer rates are different for each product
variation, the process for the slowest heating formulation of the product form
must be filed. The comment section of the filing form should state which
formulation product form heats the slowest.
You may report multiple product packing mediums on the same Form FDA 2541d
provided that:
• Factors other than “product packing medium” (e.g., container type or size) do not
require separate filing; and
• The process information you provide in Section J of Form FDA 2541d applies to
each product variation. If the heat transfer rates are different for each product
variation, the process for the slowest heating formulation of the product packing
medium must be filed. The comment section of the filing form should state which
formulation packing medium heats the slowest.
You may report multiple products with minor formulation changes (e.g., a shake base
that you produce to have a strawberry-flavored version, and a shake base that you
produce to have a vanilla-flavored version) on the same Form FDA 2541d provided
that:
• Other factors (e.g., container type or size) do not require separate filing; and
• The process information you provide in Section J of Form FDA 2541d applies to
each formulation of the product. If the heat transfer rates are different for each
product formulation variation, the process for the slowest heating formulation of
the product must be filed. The comment section of the filing form should state
which formulation heats the slowest.
Brand names of products generally should not be part of the Product Name.
However, you may need to include the brand name as part of the Product Name if it is
necessary to distinguish products that are produced using different scheduled
processes. You need not submit a separate Form FDA 2541d for each brand name of
a product that is manufactured, processed, or packed under more than one brand name
if the scheduled process for each brand is exactly the same.

When preparing separate forms that contain much of the same information (such as for a
product that you manufacture, process, or pack in multiple container sizes), you may save
time by using photocopying. Specifically, you may enter the information that applies to
all the products, photocopy the form, and then complete the product-specific information
on the photocopies. Each submitted form must be complete. Importantly, each submitted
form must have a unique SID (see Step One) and must have an original (not photocopied)
signature of an authorized company representative.
We recommend that the authorized representative make and keep a copy of each process
filing form.

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B.
Step 1: Top of Form – Food Canning Establishment Number and
Submission Identifier
Provide the FCE number and SID at the top of Form FDA 2541d, before Section A.
Leave the “Date Received by FDA” blank (this is for FDA internal use only).
1.

Food Canning Establishment (FCE) Number:

We assign a Food Canning Establishment (FCE) number to each physical processing
facility that registers using Form FDA 2541 (Ref. 1). Enter the five digit FCE number we
provide for the specific establishment (processing location) where the product(s) are
manufactured, processed, or packed after you register that establishment using Form
FDA 2541. If you are submitting a process filing at the same time as you are registering
your establishment for the first time, you may leave the FCE number blank.
2.

Submission Identifier (SID):

Each process filing is identified by a unique Submission Identifier (SID). The SID is a
unique number associated with each new process filing. You assign the SID. The
combination of the FCE number and the SID identifies a specific process filing form.
The SID is a combination of:
•
•

(1) The date (i.e., year, month, and day of the month) that a process filing form is
created; and
(2) A sequence number that would distinguish multiple forms created on the same
date. The sequence number starts with 001 and continues (002, 003) for as long as
necessary to uniquely identify all forms created on the same date.

If you create multiple types of process filing forms on the same date (e.g., if you create
three Forms FDA 2541d and three Forms FDA 2541f on the same date), the sequence
number would increase by 001 for each created form rather than begin again at 001 for
each type of form (see examples immediately below).
When you create paper forms, you assign the SID and include it on the form using the
following format:
YYYY-MM-DD/SSS
Where:
YYYY represents the calendar year (e.g., 2013, 2014)
MM represents the month (e.g., 02 for February, 10 for October)
DD represents the day of the month (e.g., 02, 19, 30)
SSS represents the assigned sequence number (e.g., 001, 002, 003).
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Examples of SIDs include:
2013-02-22/001: The first Form FDA 2541d created on February 22, 2013
2013-02-22/002: The second Form FDA 2541d created on February 22, 2013
2013-02-22/003: The third Form FDA 2541d created on February 22, 2013
2013-02-22/004: The fourth process filing form, this one a Form FDA 2541f,
created on February 22, 2013
2013-02-22/005: The fifth process filing form, this one a Form FDA 2541f,
created on February 22, 2013
2013-02-22/006: The sixth process filing form, this one a Form FDA 2541f,
created on February 22, 2013

C.

Step 2 – Section A. Product Information

1.

Food Product Group (Optional):

We request information about “Food Product Groups” to help us understand the nature of
your products. The information you provide helps FDA prioritize which commercial
processing facilities to inspect. The Food Product Group is optional information (i.e.,
you are not required to identify the Food Product Group.) If you choose to fill in this
information and there is no single best Food Product Group applicable to the product,
select “Other.”
2.

Enter Product Name.

Describe the actual food commodity or formulated food in the container (e.g., beans,
green; mushrooms (button); tuna (light); sardines (sild)).
•

If the product is named in a foreign language, provide its English equivalent first and
then provide the foreign language name in parentheses (e.g., green kidney beans
(flageolets) in brine).
The product name may include scientific names. When a scientific name is in Latin,
the product name should also include the common English translation or description
of the scientific name (e.g., mushrooms (Agaricus bisporus) pieces and stems, in
brine; Beans (Phaseolus vulgaris) in brine)

•

Brand names should not be part of the product name unless a brand name is necessary
to distinguish products that are produced using different scheduled processes.

Some product names may include qualifying terms that identify unique species,
processing methods, or organoleptic or visual properties. Some products may be
compartmentalized, and include multiple types of foods. For such products, specify these
unique properties. If, however, you are submitting the same Form FDA 2541d for
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multiple products with minor formulation differences indicate those minor formulation
differences with the product name. (See section II.A of these instructions.) For example,
if you are submitting the same Form FDA 2541d for beans that you make using green or
wax varieties, indicate those varieties as part of the product name. Some examples of
product names:
•
•
•
•
•
•
•
•
•
3.

Enter “Sardines (Sild),” not “Sardines”
Enter “Radishes, pickled (Szechuan),” not “Radishes”
Enter “Tuna (light),” not “Tuna”
Enter “Mixed vegetables, pickled (matsutake meshi-no-moto),” not “Mixed
vegetables”
Enter “Macaroni and cheese entrée with green beans and apple pie,” not “Macaroni
and cheese” (This is an example of a compartmentalized shelf stable product).
Enter “Beans (green or wax),” not “Beans”
Enter “Mushrooms (button),”not “Mushrooms”
Enter “Sugar snap peas”, not “Peas”
Enter “Refried Beans”, not “Beans”
What is the form of the product?

The product form relates to the shape or appearance of the product itself (e.g., cut, pieces
and stems, whole) rather than the characteristics of the container.
Select one or more product forms listed on the filing form. You may report multiple
forms of the product on the same Form FDA 2541d with the caveats discussed in section
II.A of this document. If none of the product forms listed on the form apply, select
“Other” and enter the product form in the space provided.
4.

What is the packing medium?

In general, “packing medium” refers to the liquid portion(s) of a product when the liquid
is added over, or added to, the solid portion(s) of a product. You may report multiple
product packing mediums on the same Form FDA2541d with the caveats discussed in
section II.A of this document.
Select one or more packing mediums listed on the form. If a product is all liquid, select
“None (i.e., the product is all liquid).” If there is no packing medium, select “Solid (no
packing medium).”

D.

Step 3 – Section B. Governing Regulation

Form FDA 2541d only applies to Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers, which are regulated pursuant to 21 CFR 108.35 and 21
CFR Part 113. Refer to Ref. 2 of this document. Therefore, Form FDA 2541d identifies
these governing regulations and you do not need to add any information to Section B.

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E.

Step 4 – Section C. Container Type

Each different container type and each different size of the same container type should be
filed as a separate Form FDA 2541d. Therefore, for any Form FDA 2541d that you
submit, select a single container type. For additional technical information about
container types, refer to Appendix – A, Container Types and Shapes.
1.

Aluminum/Tinplate/Steel Can

The first container type listed on Form FDA 2541d is for a container of all non-flexible
metal (i.e., aluminum, 3 tinplate, or steel can). Do not select Aluminum/Tinplate/Steel
Can if the container combines metal in one layer with other materials (e.g., paperboard or
a polymer) in other layers. 4
a) What is the shape of the container?
Select the shape that best applies to the container. If the container is asymmetrical in
shape, select “Irregular”, attach a picture or schematic, and in the space provided enter
the document name for the attachment. If none of the shapes apply, select “Other”,
attach a picture or schematic, and in the space provided enter the document name for the
attachment.
b) How many pieces are used to construct the container?
A 2-piece container is a container where one end is made as part of the can body. There
is no side seam and only one end is attached through the formation of a double seam.
A 3-piece container consists of a can body and two attached ends. A 3-piece container
can be identified by the presence of a side seam. The side seam runs the length of the
cylinder from one end to the other. Side seams are either cemented or welded.
You may select “2-piece container”, “3-piece container” or both, as applicable. Divider
plates are any material used to separate layers of containers. If divider plates are used,
select “Yes.” Otherwise, select “No.” For 3-piece containers, select “cemented” or
“welded” to indicate how the side seam is sealed.
c) Is the container a low-profile container?
A low-profile container is a container where the width/diameter of the container is greater
than the height (e.g., sardine can).

3

Note that we consider an aluminum can to be a non-flexible metal container rather than a semi-rigid
container.

4

Note that we consider a combination of metal and other material containers to be a retortable paperboard
or semi-rigid container.

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Select “Yes” or “No.” If yes, answer either question c.i or c.ii. If no, continue to Section
D – Container Size.
Question c.i: If a heat penetration (HP) test was conducted on nested
containers, select “c.i”, attach the heat penetration study along with a picture or
diagram of the nested containers, and in the space provided enter the document
name for the heat penetration study, then continue to Section D – Container Size.
Question c.ii: If a heat penetration (HP) test was conducted on non-nested
containers, select one of the following that prevents nesting of containers: brick
stacked, lid to lid/bottom to bottom, perforated divider plates, racks, or spiral.
2.

Ceramic/Glass

The second container type listed on Form FDA 2541d is for a container of ceramic or
glass.
a) What is the shape of the container?
Select the shape that best applies to the container. If the container is asymmetrical in
shape (e.g., boot, hat, tree), select “Irregular”, attach a picture or schematic, and in the
space provided enter the document name for the attachment. If the shape choices listed
on the form are not applicable, select “Other”, attach a picture or schematic, and in the
space provided enter the document name for the attachment.
b) Do you use perforated divider plates?
Select “Yes” or “No.” Divider plates are any material used to separate layers of
containers.
c) Is overpressure used during processing of the product to maintain container
integrity?
Overpressure is the additional external pressure often used to maintain the hermetic seal
during the processing cycle (heating and cooling). This additional pressure is generated
by the addition of compressed air into the processing vessel or by steam when using a
Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question c.i. If no, continue to c.ii through c.iv.
Question c.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig) during
heating and cooling. Enter the overpressure in pounds per square inch gauge (psig) using
a maximum of two digits before the decimal point and one digit after the decimal point
and continue to Section D – Container Size.
Question c.ii: What is the percent (%) headspace?

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Percent headspace is the fraction of volume of the void (where there is no food product)
in the container divided by the volume of the entire container multiplied by 100. Enter
the headspace using a maximum of two digits before the decimal point and one digit after
the decimal point and continue to the next question.
Question c.iii: What is the minimum initial temperature?
Minimum initial temperature (IT) is the average temperature of the contents of the
coldest container to be processed at the time the thermal process cycle begins. Enter the
minimum initial temperature in degrees Fahrenheit using a maximum of three digits
before the decimal point and one digit after the decimal point and continue to the next
question.
Question c.iv: What is the vacuum?
Control of the internal pressure depends upon the vacuum in the container. Enter the
minimum vacuum in inches of mercury (Hg) using a maximum of two digits before the
decimal point and one digit after the decimal point.
3.

Flexible Pouch

The third container type listed on Form FDA 2541d is for a container of flexible material.
A flexible pouch is a food container that has no fixed shape. Its final shape is defined by
the product placed inside it during the filling and sealing process. It is constructed of
flexible panels composed of laminated polymers. The composition of laminated polymers
varies depending on the food product, the processing method, and the intended use. Some
flexible pouches contain a foil layer.
a) What is the shape of the container?
Select the shape that applies to the container. For “Irregular” or “Other” shapes, attach a
picture or schematic of the pouch, and in the space provided enter the document name for
the attachment.
b) Is the container physically restricted during the processing of the product to
control the container thickness?
During processing, the pressure inside the pouch often exceeds the pressure inside the
processing vessel. In this instance, the pouch can expand---resulting in under processing
from poor heat penetration or rupturing from structural stresses. In place of overpressure,
physical restraints can be used to inhibit the pouch from expanding.
Select “Yes” or “No.” If yes, continue to question b.i to indicate how the container is
restricted. If no, continue to question c.
Question b.i: Racks: For containers that are physically restricted during
the processing of the product to control container thickness, this field provides a
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place to indicate whether the container is restricted by racks. Pouches can be
restrained by closely placed flat racks or racks that have indentations.
Other: For containers that are physically restricted during the processing
of the product to control container thickness, this field provides a place to indicate
whether the container is restricted by means other than racks. If racks are not
used, select “Other”, attach a picture of the restraint used, and in the space
provided enter the document name for the attachment.
c) Is overpressure used during the processing of the product to control container
thickness?
With flexible pouches, some additional external pressure may be required to conform the
container to its maximum dimensions for proper heat penetration and to avoid structural
stresses on the sealing surfaces. This additional pressure is generated by the addition of
compressed air into the processing vessel or by steam when using a Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question c.i. If no, continue to question d.
Question c.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig) during
heating and cooling. Enter the overpressure in pounds per square inch gauge (psig) using
a maximum of two digits before the decimal point and one digit after the decimal point.
d) What is the maximum thickness during retort processing?
Pouches can be processed without any physical restraints. Maximum thickness
during processing is critical for either overpressure or physical restraints. Enter the
maximum thickness in inches using a maximum of two digits before the decimal point
and two digits after the decimal point (e.g., 1.25 is a representation of 1 inch and ¼ of an
inch, 10.00 is a representation of exactly 10 inches).
e) What is the maximum residual air?
Residual air trapped inside a flexible pouch can cause significant package expansion
during processing. If the package position (e.g., vertical, on edge, etc.) or physical
restraint in the retort does not allow residual air to affect the heating rate, select “Not
Applicable.” Otherwise, enter the maximum residual air in cubic centimeters (cc) using a
whole number with a maximum of three digits and no decimal point.
4.

Retortable Paperboard Carton

The fourth container type listed on Form FDA 2541d is for a container of retortable
paperboard material.
Paperboard is a thick, paper-based material. While there is no rigid differentiation
between paper and paperboard, paperboard is generally thicker than paper (usually more
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than 0.25 mm thicker (equal to 0.010 inches or 10 points)). A paperboard container is a
container where the structure of the container is based on a wood pulp-based core which
has the consistency of thick paper or cardboard.
a) What is the shape of the container?
Select the shape that best applies to the container. If the container is rectangular (e.g.,
juice box, soup box) in shape, select “Rectangular.” Otherwise, select “Other”, attach a
picture or schematic, and in the space provided enter the document name for the
attachment.
b) Is the container physically restricted during the processing of the product to
control the container thickness?
During processing, the pressure inside the retortable paperboard carton often exceeds the
pressure inside the processing vessel. In this instance, the retortable paperboard carton
can expand---resulting in under processing from poor heat penetration or rupturing from
structural stresses. In place of overpressure, physical restraints can be used to inhibit the
retortable paperboard carton from expanding.
Select “Yes” or “No.” If yes, continue to question b.i to indicate how the container is
restricted. If no, continue to question c.
Question b.i: Racks - For containers that are physically restricted during
the processing of the product to control container thickness, this field provides a
place to indicate whether the container is restricted by racks. Retortable
paperboard cartons can be restrained by closely placed flat racks or racks that
have indentations.
Other: For containers that are physically restricted during the processing
of the product to control container thickness, this field provides a place to indicate
whether the container is restricted by means other than racks. If racks are not
used, then select “Other”, attach a picture of the restraint that is used, and in the
space provided enter the document name for the attachment.
c) Is overpressure used during the processing of the product to control
container thickness?
Overpressure is extra external pressure to avoid structural stresses on the sealing surfaces.
This additional pressure is generated by the addition of compressed air into the
processing vessel or by steam when using a Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question c.i. If no, continue to question d.
Question c.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig)
during heating and cooling. Enter the overpressure in pounds per square inch gauge
Page 16 of 44

(psig) using a maximum of two digits before the decimal point and one digit after the
decimal point
d) What is the maximum thickness during retort processing?
Retortable paperboard carton can be processed without any physical restraints.
Maximum thickness during processing is critical for either overpressure or physical
restraints. Enter the maximum thickness in inches using a maximum of two digits before
the decimal point and two digits after the decimal point (e.g., 1.25 is a representation of 1
inch and ¼ of an inch, 10.00 is a representation of exactly 10 inches).
.
e) What is the maximum residual air?
Residual air trapped inside a retortable paperboard carton can cause significant package
expansion during processing. If the package position (e.g., vertical, on edge, etc.) or
physical restraint in the retort does not allow residual air to affect the heating rate, select
“Not Applicable.” Otherwise, enter the maximum residual air in cubic centimeters (cc)
using a whole number with a maximum of three digits and no decimal point.
5.

Semi-Rigid

The fifth container type listed on Form FDA 2541d is for a container of semi-rigid
material.
A semi-rigid container is a container where the shape of the container is not altered by
filling of product at atmospheric pressures---but can be altered by additional external
pressure.
a) What is the shape of the container?
Select the shape that best fits the container. For “Irregular” or “Other” shapes, attach a
picture or schematic, and in the space provided enter the document name for the
attachment.
b) Is this a compartmentalized container?
Compartmentalized containers are containers that hold more than one food product (e.g.,
corn and green beans where corn and green beans are held in separate sections within a
single container) and the food is processed in the single container.
If the container consists of more than one compartment and the compartments contain
different food products, select “Yes” and identify the number of compartments.
Otherwise, select “No.”
c) What is the predominant material used to make the body of the container?

Page 17 of 44

Select the material that, based on weight, is the predominant material used to make the
container stock. If you select “Other,” enter the information next to “Other.”
d) What is the predominant material used to make the lid of the container?
Select the material that, based on weight, is the predominant material used to make the lid
stock. If you select “Other,” enter the information next to “Other.” If the container is a
web fed paperboard brick pack, without a lid, select “Not Applicable.”
e) How is the lid sealed to the body of the container?
Select the appropriate mechanism for how the lid is sealed to the body of the container.
If you select “Other,” enter the information next to “Other.” If the container is a web fed
paperboard brick pack, without a lid, select “Not Applicable.”
f) Is the container physically restricted during the processing of the product to
control container thickness?
During processing, the pressure inside the semi-rigid container often exceeds the pressure
inside the processing vessel. In this instance, the semi-rigid container can expand--resulting in under processing from poor heat penetration or rupturing from structural
stresses. In place of overpressure, physical restraints can be used to inhibit the semirigid container from expanding.
Select “Yes” or “No.” If yes, continue to question f.i to indicate how the container is
restricted. If no, continue to question g.
Question f.i: Racks – For containers that are physically restricted during
the processing of the product to control container thickness, this field provides a
place to indicate whether the container is restricted by racks. Semi-rigid
containers can be restrained by closely placed flat racks or racks that have
indentations.
Other: For containers that are physically restricted during the processing
of the product to control container thickness, this field provides a place to indicate
whether the container is restricted by means other than racks. If racks are not
used, then select “Other”, attach a picture of the restraint that is used, and in the
space provided enter the document name for the attachment.
g) Is overpressure used during the processing of the product to control container
thickness?
Overpressure is additional external pressure required to conform the semi-rigid container
to its maximum dimensions for proper heat penetration and to avoid structural stresses on
the sealing surfaces. This additional pressure is generated by the addition of compressed
air into the processing vessel or by steam when using a Rotomat type cooker.
Select “Yes” or “No.” If yes, continue to question g.i. If no, continue to question h.
Page 18 of 44

Question g.i: What is the total overpressure used during processing?
The total overpressure used during processing is the total gauge pressure (psig) during
heating and cooling. Enter the overpressure in pounds per square inch gauge (psig) using
a maximum of two digits before the decimal point and one digit after the decimal point.
h) What is the maximum thickness during retort processing?
Semi-rigid containers can be processed without any physical restraints. Maximum
thickness during processing is critical for either overpressure or physical restraints. Enter
the maximum thickness in inches using a maximum of two digits before the decimal
point and two digits after the decimal point (e.g., 1.25 is a representation of 1 inch and ¼
of an inch, 10.00 is a representation of exactly 10 inches).
i) What is the maximum residual air?
Residual air trapped inside a semi-rigid container can cause significant package
expansion during processing. If the package position (e.g., vertical, on edge, etc.) or
physical restraint in the retort does not allow residual air to affect the heating rate, select
“Not Applicable.” Otherwise, enter maximum residual air in cubic centimeters (cc) using
a whole number with a maximum of three digits and no decimal point.
6.

Other Container

The sixth container type listed on Form FDA 2541d is for a container of a type other than
the ones listed above.
Select “Other” when none of the container types listed on the form applies and enter the
container type.
a) Attach a schematic or picture of the container and in the space provided enter
the document name for the attachment.
b) Specify the material that, based on weight, is the predominant material used to
make the container stock. This is the material that constitutes the highest weight value of
the container stock.
c) Specify the material that, based on weight, is the predominant material used to
make the lid stock. This is the material that constitutes the highest weight value of the lid
stock. If the container does not have a lid, specify Not Applicable.
d) Specify the method used to seal the lid to the body. If the container does not
have a lid, specify Not Applicable.

F.

Step 5 – Section D. Container Size

Section D includes one required field (D.1 – Dimensions) and one optional field (D.2 –
Net Weight). Products come in a variety of container shapes (see section II.E of these
Page 19 of 44

instructions for information about container shapes). For cylindrical (including bowl and
oval) shapes, select “a” to report the container size. For rectangular (including trays)
shapes, irregular shapes, or pouches, select “b” to report the container size. Report
container dimensions in English units (number of whole inches and sixteenths of an
inch).
Refer to Appendix – B, Container Dimension Measurements for examples.
1.

Dimensions:
a) Diameter and Height

Enter information for Diameter and Height only for cylindrical (including bowl
and oval) shaped containers.
b) Length, Width and Height/Thickness
Enter information for Length, Width and Height/Thickness for container shapes
other than cylindrical.
When entering dimensions for diameter, length, width, and height/thickness, express the
dimensions by creating a round number that is a code reflecting the dimensions in inches.
The first part of the code represents the whole number of inches and the last two digits
represent the fraction of an inch in sixteenths. For example:
•
•
•
•
•

If the dimension is 12 and 8/16 inches, create the code from 12 and 08 – i.e., 1208.
If the dimension is 5 and 15/16 inches, create the code from 5 and 15 - i.e., 515.
If the dimension is 3 and ¾ inches, first express the ¾ inches in sixteenths - i.e.,
12/16. Then create the code from 3 and 12 - i.e., 312.
If the dimension is 4 inches, create the code from 4 and 00 - i.e., 400.
If the dimension is 4 and 1/8 inches, first express the 1/8 inches in sixteenths - i.e.,
2/16. Then create the code from 4 and 2 - i.e., 402.

Rounding may be necessary for sizes that are less than one sixteenth of an inch.
Rounding can be up or down depending on the measurement. If the measurement is
closer to the “higher” sixteenth, round up; if the measurement is closer to the “lower”
sixteenth, round down. For example:
•
•

2.

If the diameter is 3 and 7/16 inches and the width is 2 inches and 1/4 of one 16th
inches, the rounded dimensions will be 307 x 200
If the diameter is 4 5/16 inches, the width 3 and 1/16 inches, and height is 0.906
(14/16ths and 1/2 of one 16th of an inch), the rounded dimensions will be 405 x 301 x
015
Net Weight (Optional):

This question provides the opportunity for you to include the net weight of your product.
Although you are not required to enter this information on this filing form, entering the

Page 20 of 44

information can help FDA inspectors examining product in matching a product under
examination to the product described in this filing form.
Only the quantity of food in the container or package is stated in the net quantity
statement. Do not include the weight of the container, or wrappers and packing materials.
To determine the net weight, subtract the average weight of the empty container, lid and
any wrappers and packing materials from the average weight of the container when filled
with food.
Enter the net weight in ounces if you choose to provide this optional information using a
maximum of three digits before the decimal point and two digits after the decimal point.

G.
Step 6 – Section E. Processing Method: Thermally Processed NonAseptic System
Processing method is a general description of how the product in the container is treated
during the heating process (e.g., still, agitating).
1.

What is the finished equilibrium pH of the product after processing?

Enter the representative pH of the product after processing using a maximum of two
digits before the decimal point and two digits after the decimal point. We consider this
pH value to be an average of a range between the low and high pH of the standard
product. In instances where there is no decimal value, the decimal portion will be two
zeros.
2.

Heating medium

Heating medium is the method used to convey heat to a product during a thermal process
(e.g., water immersion, steam, water cascade, water spray, steam-air, high pressure
assisted). Select the one heating medium that comes in contact with the container.
a) Steam Air - A Steam-air medium is a carefully proportioned mixture of steam
and air. It does not use water during the heating process.
If you select “steam-air” as the heating medium, you must attach a heat
distribution study, and in the space provided enter the document name for the attachment.
The other available heating mediums are: High pressure assisted, Microwave,
Ohmic, Steam, Water cascade, Water immersion, Water spray, or Other. If you select
“Other,” enter a description of the heating medium next to “Other.”

Page 21 of 44

H.

Step 7 – Section F. Process Mode

1.

Mode

There are two overall process modes: agitating (where there is container movement and
orientation) and still (where there is no container movement).
Select one process mode and then select from the available choices applicable to that
mode. Then continue to question F.2.
a) Agitating
i. Axial (can apply to either batch or continuous)
In an axial rotating system, containers travel on their side and rotate on a longitudinal
axis around the inner circumference of the processing vessel shell in a continuous or
batch process. Select either “Batch” or “Continuous.”
ii. End over end (only applies to batch).
In an end-over-end system, the containers are loaded vertically into a crate and the crate
spins vertically 360 degrees from top to bottom.
iii. Oscillation (only applies to batch). Select either high frequency or low
frequency
In an Oscillation system, containers vibrate laterally at either a low or high frequency.
b) Still
i. Horizontal
In a horizontal still retort, the processing shell is horizontal and containers may be loaded
horizontally, vertically, or randomly (jumble) from one end of the retort. If the retort has
two doors, the product enters through one door and exits through the other door for
processing “traffic” control.
ii. Vertical
In a vertical still retort, the processing shell is oriented vertically and containers are
loaded from the top. Containers may be positioned, horizontally, vertically, or randomly
(jumble). Some of these systems are crateless systems where containers are randomly
loaded through the top and removed through the bottom.

Page 22 of 44

2.

Cooker: What type of cooker do you use?

Select one cooker type. If you select “Other,” enter the cooker type next to “Other”,
attach supporting documentation, and in the space provided enter the document name for
the attachment.

I.

Step 8 – Section G. Process System Critical Factors

In Section G of the form, you provide information about critical factors associated with
the process system. (Note that this is distinct from in Section H of the form, where you
provide information about critical factors for the product.) Under 21 CFR 113.3(f),
critical factor means “any property, characteristic, condition, aspect, or other parameter,
variation of which may affect the scheduled process and the attainment of commercial
sterility.”
1.

What is the filling method(s) used to fill the product into the container?

We list several available filling methods. Select as many as apply. Below, we describe
the listed filling methods:
•

Hand filling - the primary ingredient(s) are placed in the food container manually.
Select this method even if the brine/sauce/oil is topped off mechanically, after the
primary ingredient is placed in the container by hand.

•

Piston filling - liquid/paste/semi-solid is measured and filled by the positive
displacement of a piston evacuating a fixed volume cylinder.

•

Pocket filler - for solids/particulates that are gravity fed into a fixed volume pocket,
which is then used to put the measured ingredient into the food container.

•

Vibrating/Tumble filling - the solids are mechanically dropped into the can with or
without the assistance of vibration.

•

Volumetric filling – the liquid/sauce food product is mechanically filled.

2.

How many phases are used to fill the container with the product?

A phase is a stage of filling the product into the container. Many formulated products
contain several stages of filling where each ingredient (e.g., soup that contains vegetable,
broth, meat) is filled separately to assure a fixed ratio between them and
minimum/maximum quantities of each ingredient. Select the number of phases
appropriate to your filling method and continue to question G.2.a.
a) Enter the number of ounces added in each Phase. Phase 1; _ _ _. _ _ Phase 2; _ _ _. _ _ Phase 3; _ _ _. _ _
Enter the fill weight in ounces using a maximum of three digits before the decimal
point and two digits after the decimal point for each Phase. For example, if Two Phase is

Page 23 of 44

selected in question G.2, enter the number of ounces for Phase 1 and Phase 2 in the
appropriate spaces provided.
3.

Is the product vacuum packed?

Vacuum packed products are solid/dry packed without any fluid, and the majority of the
air is removed from the container by mechanical vacuum. If the product is vacuum
packed, select “Yes.” Otherwise, select “No.”
4.

What is the container position in the retort?

By “container position in the retort,” we mean how the containers are arranged in the
retort (e.g., horizontal, random). If you selected “Agitating” in Section F of the form,
you can skip this question and continue to the next question. Otherwise, select one of the
available container positions. Below, we describe the listed container positions.
•

Brick stacked - the containers on each layer are overlapping/offset from the
containers on the layers below/above.

•

Horizontal - the containers are on their sides.

•

Jumbled/Random - there are no layers and there is no order to the crate/retort loading.
Containers with a jumble load are at a variety of angles and positions with relation to
other containers.

•

Lid down - the containers are loaded with a specific orientation of the container lid
facing the bottom of the retort.

•

Lid up - the containers are loaded with a specific orientation of the container lid
facing the top of the retort.

•

Vertical - the containers are upright and layered, but there is no specific coordination
between the layers (unlike brick staking).

5.

Minimum Come-Up-Time

If the heating medium you selected in Section E of the form was “Steam-air”, “Water
cascade”, “Water immersion”, “Water spray”, or “Other”, provide this information as
described below. Otherwise, continue to Step 8 (Section H).
Minimum come-up-time is the amount of time between the time the steam is turned on
and the time the retort achieves processing temperature at all locations within the retort.
Enter the minimum amount of time in minutes using a maximum of two digits before the
decimal point and one digit after the decimal point, attach a temperature distribution
study, and in the space provided enter the document name for the attachment.

Page 24 of 44

6.

Minimum Water Flow Rate

If the heating medium you selected in Section E of the form was “Steam air,” you can
skip this question. Otherwise, provide the information as described below.
The minimum water flow rate refers to the minimum volume of water per unit time,
flowing through a retort system that requires water circulation (i.e., water spray, water
cascade) in the retort. If you use a water immersion system and the system does not use
a pump for circulation, select “Not Applicable,” attach an explanation, and in the space
provided enter the document name for the attachment. Otherwise, enter the flow rate in
gallons per minute (gpm) using a maximum of three digits before the decimal point and
one digit after the decimal point.

J.

Step 9 – Section H. Product Critical Factors

In Section H, you provide information about critical factors for the product. (This is in
contrast to Section G, which seeks information about critical factors associated with the
process system.) As discussed above, critical factor means any property, characteristic,
condition, aspect, or other parameter, variation of which may affect the scheduled process
and the attainment of commercial sterility.
1.

Does the product contain particulates?

Particulates are any solid or semi-solid pieces that may erode or diminish during
processing, but are still discernable in the finished product. If you select “Yes,” continue
to question H.1.a. Otherwise, select “No” and continue to question H.2.
a) Is controlling particulate size a critical factor?
Some particulates are naturally limited in size (e.g., rice, beans, peas, corn kernels) or
mechanically modified in size (e.g., cut, diced). If failing to control the size could
impact heat penetration into the particulate or impact convective heating, select “Yes”
and continue to questions H.1.b-H.1.d. Otherwise, select “No” and continue to question
H.2.
b) What is the shape and dimension of the particulate size to be controlled? If
more than one, list all that apply.
Enter the dimensions (maximum and/or minimum, as applicable) of the particle size to be
controlled, its unit of measure, and the food component to which the limitation applies
(e.g., “cuts ≥1/4 inch”; shrimp sizes such as “small”; “minimum slice thickness ≥3/16
inch”; fish balls “maximum diameter ¾ inch”; stuffed pasta tube “maximum 2 inch
length by ½ inch diameter” etc.).
c) Does your product contain fines?
Some of the processes result in the creation of fines (small pieces with increased surface
area), which could increase the tendency for the product to mat during processing. If the
Page 25 of 44

distribution of the fine pieces throughout the production is not controlled, they can
aggregate in a small group of containers or a single container, impacting heat penetration.
If your product contains fines, select “Yes” and continue to question H.1.c.i. Otherwise,
select “No” and continue to question H.1.d.
Question c.i: What is the maximum percent?
Enter the maximum percent of the fines using a maximum of three digits before the
decimal point and one digit after the decimal point.
d) Is full rehydration of the particulate a critical factor?
If full hydration is necessary before filling, select “Yes.” Otherwise, select “No.”
2.

Does the product contain any dry ingredients?

Some processors hydrate dry ingredients before filling the containers and other
processors control the liquid-dry ingredient ratio when filling, allowing for hydration in
the containers during the thermal process. If your product contains dry ingredients, select
“Yes” and continue to question H.2.a. If dry ingredients are hydrated before filling the
container, select “No” and continue to question H.3.
a) What is the minimum % moisture of dry ingredients before processing?
Enter the percent moisture using a maximum of two digits before the decimal point and
two digits after the decimal point. If the minimum % moisture is not a critical factor,
select “Not Applicable.”
3.

How are pieces arranged in the container?

In some processes, arrangement of the solid pieces in the container can impact heat
penetration (e.g. with asparagus products, the direction of the asparagus spears can affect
heat penetration).
Select one of the available choices for how pieces are arranged. If you select “Other,”
identify how the pieces are arranged next to “Other”, attach an explanation, and in the
space provided enter the document name for the attachment. If the arrangement of pieces
in the container is not a critical factor, select “Not Applicable.”
4.

Does the % total solids affect the heating of the product during processing?

In some processes, the amount of total solids in the container can impact heat penetration.
If the percent total solids affect the heating, select “Yes” and continue to question H.4.a.
Otherwise, select “No” and continue to question H.5.
a) What is the % total solids?

Page 26 of 44

Enter to the nearest tenth the maximum percent total solids in the product that is critical
to the process using a maximum of two digits before the decimal point and two digits
after the decimal point.
5.
Is the finished equilibrium pH of the product after processing (identified in
Section E) critical to the process?
In some instances, the thermal process delivered to a low-acid food product is calculated
based upon the pH of the finished product. If pH is critical to the thermal process of the
product, select “Yes.” Otherwise, select “No.”
6.

Does consistency/viscosity affect the heating of the product?

Product heating is typically based upon convection and/or conduction. For products
heated by convection and/or conduction, the consistency / viscosity of the liquids in the
container can impact heat penetration during thermal processing. If the heating of the
product is based upon control of the consistency/viscosity, select “Yes” and continue to
questions H.6.a-H.6.c. Otherwise, select “No” and continue to question H.7.
a) What instrument is used to measure the consistency/viscosity?
Enter the instrument used (e.g., Brookfield, Brabender)
b) What is the temperature when you measure the consistency/viscosity?
Enter the product temperature in degrees Fahrenheit that the reading is to be taken at
using a maximum of three digits before the decimal point and one digit after the decimal
point.
c) What is the consistency/viscosity? What is the unit of measure?
Enter the measured value using a maximum of three digits before the decimal point and
two digits after the decimal point. Specify the unit of measure either by selecting
“Centipoise,” or by selecting “Other.” If you select “Other,” enter the units of measure
next to “Other.”
Examples of other units of measure:
•
•
•
7.

Pascal-second (Pa.s)
Saybolt Seconds Universal (SSU)
Stokes (St)
Is starch added to maintain consistency/viscosity of the product?

If starch is added to achieve a desired consistency/viscosity, select “Yes” and continue to
questions H.7.a-H.7.b. Otherwise, select “No” and continue to question H.8.
a) What is the maximum % starch added?

Page 27 of 44

Enter the maximum percent starch of the total product formula weight using a maximum
of two digits before the decimal point and two digits after the decimal point.
b) What type of starch is added?
Enter the type of starch added to the product.
Examples of starch types:
•
•
8.

Modified Corn starch
Potato starch
Are other binders added?

If binders other than starch are added to achieve a desired consistency/viscosity, select
“Yes” and continue to questions H.8.a-H.8.b. Otherwise, continue to question H.9.
a) What is the maximum % binder added?
Enter maximum percent binder of the total product formula weight using a maximum of
two digits before the decimal point and two digits after the decimal point.
b) What type of binder is added?
Enter the type of binder added to the product.
Examples of binder types:
•

Gelatin

•

Xanthan Gum

9.
Does syrup strength affect the heat penetration during processing of the
product?
Syrups are included as ingredients in many products to achieve a desired taste and
sensory quality. If adding syrups is critical to how the product heats, select “Yes” and
continue to question H.9.a. Otherwise, continue to Section I.
a) What is the brix measurement?
Degree Brix is the % sugar, by weight, of an aqueous solution. Enter the maximum
degrees (Brix) to the nearest one decimal place of a degree (e.g., 30.0) using a maximum
of two digits before the decimal point and one digit after the decimal point.

Page 28 of 44

K.

Step 10 – Section I. Process Source

1.

Process Source:
a) What is the Process Source?

The process source is the individual or entity (e.g., organization, company, individual,
university, or other entity) that establishes the scheduled process. Scheduled processes for
low-acid foods must be established by qualified persons having expert knowledge of
thermal processing requirements for low-acid foods in hermetically sealed containers and
having adequate facilities for making such determinations.
Enter the name of the process source who scientifically established the scheduled
process(es), attach the support documentation containing the process recommendations
(e.g., letter, bulletin, scientific paper), and in the space provided enter the document name
for the attachment. You may refer to 21 CFR 113.83 for more detailed requirements
concerning establishing scheduled processes. Below, we provide some examples of how
to name the process source.
•

If the process was established by your facility, enter the facility’s name.

•

If the process was established by an organization, individual, university or other
entity, enter the name of that entity (followed by the name of an individual, as
appropriate).

•

If the process was established by a reference source document or publication, enter
the reference source document.
b) What is the date of the Process Source Document?

Enter the date of the process source document that is attached in month/day/year format.
2.

What is the Manufacturer’s Name and the Sterilizer Model?

If you selected the process mode “Still” in Section F of the form and you selected the
heating medium “Steam” in Section E of the form, you may, if applicable, select
“Unknown/Locally Made” check box, attach pictures and supporting documentation, and
in the space provided enter the document name for the attachment.
Otherwise, enter the manufacturer’s name and the model of the sterilizer. Do not include
in the name “still,” “agitating,” “hydrostatic,” “vertical,” or “horizontal.”

L.

Step 11 – Section J. Scheduled Process

Under 21 CFR 113.3(r), scheduled process means the process selected by the processor
as adequate under the conditions of manufacture for a given product to achieve
commercial sterility. The scheduled process, which is the process established by a

Page 29 of 44

qualified process source as described in section II.K.1 of this document, may be in excess
of what is necessary to ensure destruction of microorganisms of public health
significance.
List each process on a single line, except for a multiple-step process. In a multiple-step
process, only list the minimum initial temperature for the first step. In addition, only list
the cumulative lethality value (i.e. total F value for all steps) for the last step.
For each listed process, you must provide information in columns 1-6. Whether you must
provide information in columns 7 through 13 depends on the processing system. In the
instructions for columns 7 through 13, we identify the processing systems that require
data entry in those columns.
1.

Column 1. Process No.

Each process has its own process number. Enter the number 1 in the first row, the
number 2 in the second row, and continue entering numbers in increments of 1 for each
scheduled process that you list. The process number increases by increments of 1
regardless of the number of steps in each scheduled process.
2.

Column 2. Step

A process may have one or more steps. For a single-step process, enter the number 1 in
column 2. When the process has multiple steps, enter the number 1 for the first step, the
number 2 for the second step, and continue entering numbers in increments of 1 for each
subsequent step.
3.

Column 3. Minimum Initial Temperature

Minimum Initial temperature (IT) is the lowest initial temperature permitted in the
scheduled process. IT is the average temperature of the contents of the coldest container
to be processed at the time the thermal process cycle begins. This may be calculated by
agitating/shaking the filled, sealed container to mix the contents before obtaining this
value.
Enter the minimum initial temperature in degrees Fahrenheit using a maximum of three
digits before the decimal point and one digit after the decimal point.
4.

Column 4. Process Time

Enter the duration of the process time using a maximum of three digits before the decimal
point and two digits after the decimal point. If the duration is a whole minute, enter the
number of minutes and two zeros for the decimal portion.
Examples of how to enter process time:
•

If the process time is 15 minutes and 30 seconds, enter 15.50

Page 30 of 44

•
5.

If the process time is 150 minutes and 0 seconds, enter 150.00
Column 5. Process Temperature

Enter the temperature of the step in degrees Fahrenheit using a maximum of three digits
before the decimal point and one digit after the decimal point.
6.

Column 6. Fo (F18/250)

Enter the number of minutes that the process requires to achieve commercial sterility
using a z value of 18 degrees and a reference temperature of 250 degrees Fahrenheit.
Enter the number of minutes using a maximum of two digits before the decimal point and
two digits after the decimal point.
Examples of how to enter the Fo:
•

6.00

•

6.35

7.

Column 7. Thruput (Containers per Minute)

Answer this question only if you selected “Agitating – Axial Continuous” in Section F of
the form. Enter the number of food containers going through the processing system per
minute using a whole number with a maximum of four digits and no decimal point. The
value entered should be the maximum number of containers per minute that provides the
basis for the filed process time.
8.

Column 8. Headspace

Answer this question only if you selected “Agitating” in Section F of the form. Select
either 1) Net, 2) Gross, or 3) NA.
Net headspace is the vertical distance between the level of the product (generally the
liquid surface) in an upright rigid container and the lowest inside surface of the lid. Gross
headspace is the vertical distance between the level of the product (generally the liquid
surface) in an upright rigid container and the top edge of the container (the top of the
double seam of a can or the top edge of a glass jar).
If you select net or gross headspace, enter in this column the value in inches using one
digit before the decimal point and four digits after the decimal point. If you enter a zero
as the digit before the decimal point, you must follow the zero with a decimal value (e.g.,
0.125). If you select “NA,” do not enter any numerical values in this column.
9.

Column 9a. Reel Speed

Answer this question only if you selected “Agitating - End Over End” or “Agitating Axial” in Section F of the form. Enter the reel speed in rotations per minute (rpm) of the
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agitation that provides the basis for the filed process time and report the value using a
maximum of two digits before the decimal point and two digits after the decimal point.
10.

Column 9b. Reel Diameter

Answer this question only if you selected “Sterlimatic” in Section F of the form. Enter
the diameter of the reel in inches using a whole number with a maximum of three digits
and no decimal point.
11.

Column 9c. Steps per Turn of the Reel

Answer this question only if you selected “Agitating - Axial Continuous” in Section F of
the form. Enter the number of containers held in a 360 degree rotation of the reel that
provides the basis for the filed process time, using a whole number with a maximum of
two digits and no decimal point.
12.

Column 9d. Chain / Conveyor Speed

Answer this question only if you selected “Hydrolock” or “Hydrostatic” cooker type in
Section F of the form. Select either 1) Feet, 2) Carriers, or 3) Flights. In this column,
enter the value for the speed per minute using a maximum of three digits before the
decimal point and three digits after the decimal point.
13.

Column 9e. Cooker Capacity

Answer this question only if you selected “Sterilmatic” in Section F of the form.
Enter the maximum number of containers that each cooker shell holds that provides the
basis for the filed process time, using a whole number with a maximum of four digits and
no decimal point. Do not include infeed or discharge valves. For processes with multiple
shells in a multiple step process, enter the cooker capacity for each step on the
appropriate step.
14.

Column 9f. Frequency Strokes per Minute (Oscillation Agitating ONLY)

A stroke is the single movement in any direction up or down or side to side. The
frequency is the number of strokes per period of time. Oscillating Agitating includes
rocking or planar agitation. Answer this question only if you selected “Agitating Oscillation” in Section F of the form.
Enter the strokes per minute using a maximum of three digits before the decimal point
and two digits after the decimal point.
15.

Column 10. Maximum Fill Weight

The maximum fill weight includes the weight of the entire product in the container,
including brine or sauce, but does not include the weight of the container. The maximum
fill weight is recorded before processing.
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Enter the maximum fill weight in ounces using a maximum of three digits before the
decimal point and two digits after the decimal point. If the process authority determines
this is not critical to the process, select “NA” under the column header and do not enter
any numerical values.
16.

Column 11. Minimum Free Liquid at Closing

Answer this question only if you selected “Yes” to question G.3 (product vacuum
packed) under Section G of the form. Enter the amount of free liquid (e.g., water and/or
brine) using a maximum of two digits before the decimal point and two digits after the
decimal point.
17.

Column 12. Minimum Container Closing Machine Gauge Vacuum

Answer this question only if you selected “Yes” to question G.3 (product vacuum
packed) under Section G of the form. Enter minimum container closing machine gauge
vacuum in inches of mercury (Hg) using a maximum of two digits before the decimal
point and two digits after the decimal point. Also enter the temperature in degrees
Fahrenheit plus or minus 3 degrees as specified by the process source using a maximum
of three digits before the decimal point and two digits after the decimal point.
18.

Column 13. Other

If there are any other critical factors whose values have been specified by the process
source as critical to the delivery of the scheduled process, enter them in the column
heading and provide the applicable values for each scheduled process. If no additional
critical factors have been identified by the process source, leave this column blank.
Example for Other:
•

M.

Cooling Water Temperature – 100 degrees F

Step 12 – Section K. Additional Information (Optional)

Under this section of the form, you may enter additional information and/or attachments.
If you attached a required heat penetration study under Section C of the form or an
optional heat penetration study under this section of the form, you may enter the heat
penetration data from that study by selecting the checkbox and entering the information
as identified below.
1. Heat Penetration Data (Optional):
Enter applicable values:
•

j value - Identify the j value reported in the heat penetration study in minutes using a
maximum of two digits before the decimal point and two digits after the decimal
point.

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•

fh value - Identify the fh value reported in the heat penetration study in minutes using
a maximum of three digits before the decimal point and two digits after the decimal
point.

•

f2 value - Identify the f2 value reported in the heat penetration study in minutes using
a maximum of three digits before the decimal point and two digits after the decimal
point.

•

jc value - Identify the jc value reported in the heat penetration study in minutes using
a maximum of two digits before the decimal point and two digits after the decimal
point.

•

fc value - Identify the fc value reported in the heat penetration study in minutes using
a maximum of three digits before the decimal point and two digits after the decimal
point.

•

x (xbh) value - Identify the x (xbh) value reported in the heat penetration study in
minutes using a maximum of three digits before the decimal point and two digits after
the decimal point.

For optional attachments, there are three choices listed. You may select one or more
choices and identify the document name adjacent to the appropriate choice(s).
2.

Comments:

Enter any additional information you consider pertinent to the product and/or the
scheduled process critical factor(s). Comments are optional unless you report multiple
forms of the product, multiple packing mediums, or multiple product variations, in which
case comments may be required in some circumstances as discussed under section II.A
(General Information) in this document.
If you report multiple forms of a product (e.g., diced, chunks, cut, fillet), multiple
packing mediums, or multiple products with minor formulation changes on a single form,
the heat transfer rates may differ for each product variation. In such cases, the process
for the slowest heating formulation of the product or its packing medium must be filed
and you should use the comment box section to specify which formulation packing
medium heats the slowest.
If you consider any additional information pertinent to the product and/or the scheduled
process critical factor(s), enter that information in the comment box and/or attach one or
more documents containing the additional information as discussed under section II.K.
3.

Full Name, Signature, Establishment Name and Date

Print the first and last name of the person authorized to represent the facility, as well as
the FCE facility name, state (for US) or province (for foreign countries), and country.

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The person authorized to represent the facility must sign and date the form and provide
the authorized person’s telephone number.

III. How to Contact FDA or Obtain Help
You may contact us:
•
•
•

By email at LACF@fda.hhs.gov;
By telephone at 240-402-2411; and
By mail at the address immediately below.

Food and Drug Administration
LACF Registration Coordinator (HFS-303)
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, Maryland 20740-3835

IV. References
1. Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food
Process Filing Forms) to FDA in Electronic or Paper Format
2. LACF/AF Precursor Questions

V.

Appendix

A.

Container Types and Shapes

Figure 1 – Cylindrical Shape 2-Piece Aluminum Containers Depicting Double Seams

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Figure 2 – Low-Profile Rectangular Shape 2-Piece Aluminum Containers

Figure 3 – Cylindrical Shape 3-Piece Steel Containers with a Double Seam and Side Seam

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Figure 4 – Cylindrical Shape 2-Piece Steel Containers with a Double Seam

Figure 5 – Flexible Pouch

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Figure 6 – Glass Containers

Figure 7 – Semi Rigid Body, Oval Shape Containers with Heat Seal

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Figure 8 – Semi Rigid Body, Rectangle Shape Containers

Figure 9 – Semi Rigid Body with an Aluminum Double Seam

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Figure 10 – Semi Rigid Body, Cylinder Shape Containers with Induction Weld Seal

Figure 11 – Semi Rigid Body with Heat Seal

B.

Container Dimension Measurements

Container dimension measurements should always be measured from the outside edge of
the container. Below, we list different types of materials and descriptions of how to
properly measure the dimensions of the container.

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1.

Cylindrical Measurement

Measure the diameter from the outside of the double seam on the container. Measure the
height from the top of the double seam to the opposing double seam top. If the can is a
two piece can, measure from the top of the double seam to the furthest point on the other
end. For glass bottles or unusually shaped cylindrical containers, always measure the
widest part of the container.
For heat-sealed, semi-rigid containers, do not measure the sealing flange as part of the
container dimensions. Only measure from the inner edge of the flange where the seal
edge meets the chamber holding the food.
When measuring cylindrical shaped containers, list diameter x height (e.g., 0211 x 0400
for a 2 11/16 inch x 4 inch container).

Figure 12 – Measurement of a Cylindrical Shape Container.

When measuring unusually shaped cylindrical containers, always measure the widest part
of the container.

Figure 13 – Measurement of an Unusual Shape Cylindrical Container.

2.

Oval Shape Measurement

When measuring unusually shaped oval containers, always measure the widest part of the
container.

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Figure 14 – Measurement of an Oval Shape Container

Figure 15 – Measurement of Outer Edges of Container

3.

Rectangular Shape, Rectangular Tray and Low-Profile Measurement

For all rectangular containers (including trays), list length (longest dimension) x width
(second longest dimension) x height; for example, list 0405 x 0301 x 0014 for a container
that is 4 5/16 inches long, 3 1/16 inches wide, and 14/16 of an inch.
For a rectangular can, measure the length and width from outside of the double seam.
When measuring the height of the container, measure from the top of the double seam to
the furthest point on the bottom.
For a rectangular pouch, measure from the inner edge of the seams for the length and
width. For the height, measure the thickness at the thickest point.
For paper board rectangular containers, measure the length, width, and height from the
outside edge of the container.

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4.

Rectangular Shape Measurement

Figure 16 – Measurement of a Rectangular Shape Container

5.

Rectangular Tray Measurement

Figure 17 – Measurement of a Rectangular Tray Shape Container

6.

Low-Profile Measurement

Figure 18 – Measurement of a Low-Profile Container

C.

Abbreviations

Abbreviation

Full Term

AF

Acidified Food

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AR

Authorized Representative

ECP

Establishment Contact Person

FCE

Food Canning Establishment

FFR

Food Facility Registration

FIS

FDA Industry System

FURLS

FDA Unified Registration and Listing Systems

LACF

Low-Acid Canned Foods

ROAR

Read Only Authorized Representative

SID

Submission Identifier

SUPER AR

Super Authorized Representative

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