Form 2541c Food Processing for Low Acid Aseptic

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NOTE: No commercial processor shall
engage in the processing of low-acid
foods unless completed Forms FDA 2541
and FDA 2541c have been filed with the
Food and Drug Administration, 21 CFR
108.35 (c)(1) and (2).

Food and Drug Administration

FOOD PROCESS FILING FOR LOW-ACID ASEPTIC SYSTEMS
(USE FDA BOOKLET TITLED "ASEPTIC PACKAGING SYSTEM SUPPLEMENT")

(TYPE OR PRINT ALL INFORMATION REQUESTED, IF AN ITEM DOES NOT APPLY ENTER "NA". FILE ACIDIFIED ASEPTIC (pH 4.6 or BELOW) ON FORM 2541a)

FORM APPROVED: OMB No. 0910-0037
EXPIRATION DATE: 8/31/2011

FDA USE ONLY
DATE RECEIVED BY FDA

7. PRODUCT NAME, FORM OR STYLE, AND PACKING MEDIUM

1. FCE
2. ESTABLISHMENT NAME
ADDRESS (No. and Street)

8. NAMES OF STERILIZING SYSTEMS
a. Product1

CITY

STATE
COUNTRY

ZIP (OR OTHER POSTAL CODE)
3. SID

2 0
Y

4.

Y

-

NEW

5.

6. SUP SID

11. MAXIMUM
WATER
ACTIVITY2

Y

Y

Y

Normal

M

M

D

D

S

Max.3

.

-

Y

Y

Y

Y

Y

Y

Y

Y

M

M

M

M

-

/
D

D

D

D

b.
S

S

S

S

S

S

10. CONTAINER TYPE (Check one)
Aluminum
Tinplate or
b.
a.
Can
Steel Can

/

-

S

d.

S

.

61

Percent Solids

62

Ratio of Solids to Liquids

63

Syrup Strength

68

Method of Preparation

70

Formulation

71

Rehydration (specify method
in 22)
Particulates (specify maximum size in 22)
Other (specify in 22)

Value at
Other Temp

.
18.
No.

Other
o
Temp ( F)

Units

Method Name

Glass

14. SPECIFIC
GRAVITY
o
AT 77 +_ 2 F

.

.

CONTAINER DIMENSIONS
(Inches and Sixteenths)

Diameter or
Length

Height or
Width

Height

19.
Minimum
Initial4
Temp (oF)

SCHEDULED PROCESS
Time (sec)

Temp (oF)

Least
Sterilizing
Value (Fo)5

Flow
Correction
Factor

20. MAXIMUM
FOOD FLOW
RATE (gal /
min)

15. INSIDE DIAME-

TER OF HOLDING
TUBE (Inches)

.

21. THRUPUT
(containers /
minute)

16. HOLDING
TUBE LENGTH
(Inches)

.
FOOTNOTES
1 For steam injection, enter volume
increase and thermal expansion
factors in 22.
2 If reduced water activity is used as
an adjunct to the process, specify the maximum water activity.

1

.

.

.

2

.

.

.

3

.

.

.

4

.

.

.

5

.

.

.

4 If a critical factor is in the process.

6

.

.

.

5 Or equivalent scientific basis of
process adequacy.

3 Where acidification is followed for
normally low-acid fruits, vegetables or vegetable products for
the purpose of thermal processing, specify the maximum
finished product equilibrium pH.

AUTHORIZED COMPANY REPRESENTATIVE

22. COMMENTS

FORM FDA 2541c (4/10)

c.

Other (Specify below and in item 22 if necessary)

13. MAXIMUM CONSISTENCY OR VISCOSITY IN CENTIPOISES OR APPROPRIATE UNITS
Value at
o
77+_ 2 F

17. OTHER CRITICAL CONTROL
FACTORS (Check all that apply)

73

S

/

12. pH

0.

72

S

REPLACES

-

Date (mm/yyyy)

a.
S

ALTERNATE FOR

2 0
Y

D D

CANCELS

SCHEDULED

9. PROCESS ORIGIN
No. Source for 8.a. and 8.b.

/

M M

Y Y

b. Packaging

PREVIOUS EDITION IS OBSOLETE

NAME (Type or Print)

TITLE

SIGNATURE

DATE

PHONE NO.

PSC Graphics: (301) 443-1090

EF

LACF Contact Information
E-mail: [email protected]
Telephone: 301-436-2411
LACF REGISTRATION COORDINATOR (HFS-303)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740

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FORM FDA 2541c (4/10)

Page 2

PREVIOUS EDITION IS OBSOLETE