Form FDA 2541g Form FDA 2541g Food Process Filing for Low-Acid Aseptic Systems

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g)
Note: There are separate process filing forms for each of the following: Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d); Food Process Filing for
Acidified Method (Form FDA 2541e); Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f); and Food Process Filing for Low-Acid Aseptic
Systems (Form FDA 2541g).
USE FDA INSTRUCTIONS ENTITLED “Instructions for Paper Submission of Form FDA 2541g (Food Process Filing for Low-Acid Food Aseptic Systems)"
Date Received by FDA _ _ /_ _/_ _ _ _ (MM/DD/YYYY) (FDA USE ONLY)
Food Canning Establishment (FCE) Number: _ _ _ _ _ _
Submission Identifier (SID) 20_ _-_ _-_ _/_ _ _ (YYYY-MM-DD/SSS)
A. Product Information:
Note: Section A.1 (Food Product Group) requests optional information.
1. (Optional) Select one Food Product Group. If there is no single best Food Product Group that applies, select Other.
Baby Food (infant/junior foods including infant formula);
Beverage Base;

Bakery Products (canned brown bread, bakery glazes);

Berry/Citrus/Core Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping;

Breakfast Foods (liquid form – ready-to-eat, such as porridge, gruel);

Cheese (does not include soy cheese or imitation dairy);
Dietary Supplement and/or herbal and botanical teas;
Fruit as a Vegetable (Select one):

Cocoa;

Coffee/Teas (excluding herbal and botanical teas);

Dairy (milk-based);

Dressings/Condiments (e.g., salad dressing, chutney, salsa, pepper sauce, etc.);

Fruit as a Vegetable (e.g., eggplant, pumpkin, etc.)

Fruit as a Vegetable Juice or Drink (e.g., eggplant juice, pumpkin juice, etc.);

Gelatin, Pudding Filling for Pies, Pie Filling (liquid form ready–to-eat such as apple pie filling, etc.);
products);

Gravies/Sauces (spaghetti sauce, mushroom gravy);

Imitation/Pit/Mixed/Subtropical Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping; Leafy/Stem Vegetables (Select one):
spinach juice, etc.)

Leafy/Stem Vegetable;

Imitation Dairy (includes soy-based

Leafy/Stem Vegetable as a Juice or Drink (e.g.,

Meal Replacement/Medical Foods (e.g., supplemental liquid nutrition, etc.);
Mixed Vegetables (Select one):
Nut Spread and Nut Topping;

Mixed Vegetables (e.g., carrots and peas, etc);
Other Vegetables;

Root and Tuber Vegetables (Select one):

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Mixed Vegetables as a Juice or Drink (e.g., carrot and green bean juice, etc.);

Rice, Wheat, Oat or Grain (liquid form – ready-to-eat such as grits);

Root/Tuber Vegetables (e.g., carrots, leeks, potatoes, etc.);

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Root/Tuber Vegetables as a Juice or Drink (e.g., carrot juice, etc.);

Form FDA 2541g

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Soup;;

Sweet Goods/Dessert (liquid form – ready-to-eat, such as pudding);

Vine/Other Fruit as a Jam, Jelly, Preserve, Drink, Syrup, Topping;

Wine Cooler;
Other
2. Enter Product Name (e.g., Cheese Sauce (with Jalapeno Pieces), Pudding (Vanilla or Strawberry), etc.).

3. What is the form of the product?
Liquid (i.e., all liquid no solids)
Liquid with Solids (e.g., diced, chunks, pieces, etc.)
Other (Enter product form) _________________________________________________________

Paste/Puree

4. What is the packing medium?
Brine
Cream/Sauce/Gravy
Oil
Syrup
Water
None (i.e., the product is all liquid)
Other (Enter packing medium)_______________________________________________________
Continue to Section B.
___________________________________________________________________________________________________________________________________________________________

B. Governing Regulation: (Refer to the precursor questions in the instructions)
Low-acid (21 CFR 108.35 and 21 CFR Part 113)
Continue to Section C.
_________________________________________________________________________________________________________________________________________________________

C. Container Type: (Select one)
Note: If the product is not packaged in one of the container types identified below, select Other.
1.

2.

Aluminum/Tinplate/Steel Can
a) What is the shape of the container? (Select one)
Cylindrical
Irregular (Attach a picture or schematic) _________________________________________________________________
Rectangular
Other (Attach a picture or schematic) _________________________________________________________________
b) How many pieces are used to construct the container? (Select one or more choices, as applicable)
i.
2-pieces
ii.
3-pieces How is the side seam sealed? (Select one)
Cemented
Welded
Flexible Pouch
a) What is the shape of the container? (Select one)
Flat pouch
Gable top
Gable top/side gusseted
Gusseted
Irregular (Attach a picture or schematic) ______________________________________________________________
Other (Attach a picture or schematic) _________________________________________________________________

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Form FDA 2541g

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Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
3.

Semi-Rigid
a) What is the shape of the container? (Select one)
Bowl
Cylindrical
Irregular (Attach a picture or schematic) ________________________________________________________
Oval
Rectangular
Tray
Other (Attach a picture or schematic) ____________________________________________________________
b) Is this a single piece container?
Yes (Continue to d)
No (Continue to c)
c) Is this a compartmentalized container?
Yes How many compartments? _ _
No
d) What is the predominant material used to make the body of the container? (Select one)
HDPE (high-density polyethylene)
HDPP (high-density polypropylene)
Paperboard
PET (polyethylene teraphthalate)
Other (Enter material) _________________________________
Note: If “Yes” is selected as a single piece container in question 3.b, continue to Section D.
e) What is the predominant material used to make the lid of the container? (Select one)
Aluminum/Steel
HDPE (high-density polyethylene)
HDPP (high-density polypropylene)
Nylon
PET (polyethylene teraphthalate)
Other (Enter material) _____________________________________
Not Applicable
f) How is the lid sealed to the body of the container? (Select one)
Double Seam
Heat Seal
Induction Weld
Press Twist
Snap On
Threaded Closure
Ultrasonic Seal
Other (Enter seal type) __________________________________________
Not Applicable

4.

Other (Enter container type) ____________________________
a) Attach schematic or picture of container. ______________________________________________________________________________________________
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 predominant material used to make the lid. 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 of the container. If the container does not have a lid, specify Not Applicable. __________________________

Continue to Section D.

_______________________________________________________________________________________________________________
D. Container Size:
Note: Section D.1 (dimensions) is required information; however, volume is acceptable for container size in lieu of container dimensions if package sterilizer does not depend on the container
dimensions. Section D.3 (net weight) is optional information.
1. Dimensions:
a) _ _ _ _ Diameter _ _ _ _ Height (Use for cylindrical shapes) (see accompanying instructions for proper coding)
b) _ _ _ _ Length _ _ _ _ Width _ _ _ _ Height/Thickness (Use for rectangular shapes, pouches, or irregular shapes) (see accompanying instructions for proper coding)
2. Volume: _ _ _._ (Select one)

Fluid Ounces

Gallons

Liters

Milliliters

3. Net Weight (Optional): _ _ _._ _ (enter in ounces)
Continue to Section E.
_____________________________________________________________________________________________________________________________________________________
E. Product Processing Method: Thermally Processed using Aseptic Systems:
1. Product Sterilization:
a) What is the finished equilibrium pH of the product after processing? _ _._ _

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Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
b) Heating Method
i. (Select one)
Direct Heating
Indirect Heating
ii. What is the Thermal Expansion Coefficient? _._ _
iii. Where is the product flow rate controlled? (Select one)
Before the heater (Continue to b.iii.1)
(1) Volume Expansion Factor: _._ _ (Direct Heating Only)

After the heater (Continue to c)

c) What is the Manufacturer’s name and the model number of the Product Sterilization System? ________________________________________________________________________________________
d) What is the Process Source of the Product Sterilization System? _______________________________________________ (Attach Process Source document) __________________________________
e) What is the date of the Process Source Document of the Product Sterilization System (mm/dd/yyyy)? _ _/_ _/_ _ _ _

Continue to Section F.
___________________________________________________________________________________________________________________________________________________
F. Product Critical Factors: (Complete all product critical factor questions as delineated by process authority to assure commercial sterility.)
1. Does the product contain particulates?
Yes (Attach supporting documentation and validation reports) ____________________________________________ (Continue to a)
No (Continue to F.2)
a) Is controlling particulate size a critical factor?
Yes (Continue to b)
No (Continue to F.2)
b) What is the shape and dimension of the particulate size to be controlled? If more than one, list all that apply. ___________________________________________________________________
_____________________________________________________________________________________________________________________________________________________________
2. Does the product contain any dry ingredients that are hydrated before processing the product?
a) What is the minimum % moisture of the hydrated dry ingredients before processing? _ _._ _
3. Does the % total solids affect the heating of the product during processing?
a) What is the % total solids? _ _._ _

Yes (Continue to a)
Not Applicable

Yes (Continue to a)

No (Continue to F.3)

No (Continue to F.4)

4. Is the finished equilibrium pH of the product after processing (identified in Section E) critical to the process?

Yes

No

5. What is the flow correction factor used during the scheduled process? (Select one)
a)
0.5 (Laminar) (Continue to Section G)
b)
0.83 (Turbulent) (Continue to F.6)
6. Answer the following questions if the flow correction factor you identified in question F.5 is 0.83 (Turbulent)
a) What is the instrument used to measure the consistency/viscosity? _________________________________________________
b) What is the temperature when you measure the consistency/viscosity? _ _ _._ (enter in Fahrenheit).
c) What is the consistency/viscosity? _ _ _._ _ What is the unit of measure? (Select one)
Centipoise
Other (Enter the units of measure) ____________________________
d) What is the specific gravity? _._ _ _ _
7. Is starch added to maintain consistency/viscosity of the product?
Yes (Continue to a-b)
a) What is the maximum % starch added? _ _._ _
b) What type of starch is added? _______________________________________________

No (Continue to F.8)

8. Are other binders added?
Yes (Continue to a-b)
No (Continue to F.9)
a) What is the maximum % binder? _ _._ _
b) What is the type of binder added? __________________________________________________
9. Is syrup strength a critical factor that needs to be controlled during processing?

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Yes (Continue to a)

No (Continue to Section G)

Form FDA 2541g

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
a) What is the brix measurement? _ _._
Continue to Section G.
__________________________________________________________________________________________________________________________________________________________
G. Package Sterilization System and Supplemental Information:
1. Sterilization System
a) What is the Manufacturer name and the model number of the sterilization system used to sterilize the packaging of the product? __________________________________________________________
b) What is the Process Source of the Package Sterilization System? ____________________________________________________________________________________
c) What is the date of the Process Source of the Package Sterilization System (mm/dd/yyyy)? _ _/_ _/_ _ _ _
d) Supplemental Submission Identifier (SUP SID): _ _ _ _-_ _-_ _-_ _ _
(Attach Supplemental Information) (see accompanying instructions) _______________________________________
2. Sterilization System
a) What is the Manufacturer name and the model number of the sterilization system used to sterilize the packaging of the product? __________________________________________________________
b) What is the Process Source of the Package Sterilization System? ___________________________________________________________________________________
c) What is the date of the Process Source of the Package Sterilization System (mm/dd/yyyy)? _ _/_ _/_ _ _ _
d) Supplemental Submission Identifier (SUP SID): _ _ _ _-_ _-_ _-_ _ _
(Attach Supplemental Information) (see accompanying instructions) _______________________________________
3. Sterilization System
a) What is the Manufacturer name and the model number of the sterilization system used to sterilize the packaging of the product? __________________________________________________________
b) What is the Process Source of the Package Sterilization System? __________________________________________________________________________________
c) What is the date of the Process Source of the Package Sterilization System (mm/dd/yyyy)? _ _/_ _/_ _ _ _
d) Supplemental Submission Identifier (SUP SID): _ _ _ _-_ _-_ _-_ _ _
(Attach Supplemental Information) (see accompanying instructions) _______________________________________
4. Sterilization System
a) What is the Manufacturer name and the model number of the sterilizing system used to sterilize the packaging of the product? ___________________________________________________________
b) What is the Process Source of the Package Sterilization System? ________________________________________________________________________________
c) What is the date of the Process Source of the Package Sterilization System (mm/dd/yyyy)? _ _/_ _/_ _ _ _
d) Supplemental Submission Identifier (SUP SID): _ _ _ _-_ _-_ _-_ _ _
(Attach Supplemental Information) (see accompanying instructions) _______________________________________

Continue to Section H.
__________________________________________________________________________________________________________________________________________________________

H. Scheduled Process:

Col. 1
Process
No.

Col. 2
Hold
Tube
Section

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Col. 3
Inside
Diameter
of Hold

Col. 4
Hold Tube
Section
Length

Col. 5
Initial
Temperature

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Col. 6
Process Time

Col. 7
Temperature
(at exit of final
hold tube

Col. 8
Fo (F18/250)

Col. 9
Maximum
Product
Flow Rate

Form FDA 2541g

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA
Tube
Section

Number
__

Number
__

Inches
_._ _ _

Inches
_ _ _ _._ _ _

(*only for
heating with
control of flow
rate before the
heater)
◦Fahrenheit
_ _ _._

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I. Additional Information (Optional):
Other (Attach document) _____________________________________________________________________________________________________________

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Comments:

Full Name (Please Type or Print)
Establishment Name

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Formatted Table

Signature
State or Province

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Country (other than U.S.)

Date

Telephone No

Form FDA 2541g

Draft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA

LACF Contact Information
For more information, contact the LACF Registration Coordinator by e-mail at [email protected] or phone: 240-402-2411
For paper submissions, send completed forms to:

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

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of information is estimated to average .75 hour per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send
comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this
burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
1350 Piccard Drive, Room 400
Rockville, MD 20850
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB number.”

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Form FDA 2541g