Form 2541a Process Filing For All Methods Except Low - Acid Aseptic

DEPARTMENT OF HEALTH AND HUMAN SERVICES

A. PRODUCT

PUBLIC HEALTH SERVICE

(Use FDA booklet titled: "Instructions for Establishment Registration and
Process Filing for Acidified and Low-Acid Canned Foods" for completing
Form FDA 2541a.)

FOOD AND DRUG ADMINISTRATION

FOOD PROCESS FILING FOR ALL METHODS EXCEPT LOW-ACID ASEPTIC

.

Name, Form or Style, and Packing Medium:
pH:
(Before Acidification)
Governing Regulation:

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

See Burden Statement on page 3.

20

low-acid (21 CFR 108.35/113)
acidified (21 CFR 108.25/114)

B. PROCESSING METHOD

Y Y Y Y

Process Use:

Type of Submission:
new
replaces
cancels

scheduled
alternate for
emergency for

FCE

M M

D D

S S S

SID

NAME OF STERILIZER (MFR. & TYPE)
HEATING MEDIUM (e.g., Steam, water, immersion or spray, steam-air)

1.

Still
Horizontal
a.

2.
b.

a.

Vertical

Divider Plates (complete for a. or b.)
None
Perforated
b.
c.

Crateless
Bottom Surface (complete for c.)
Solid
Perforated

Agitating
End over End
Axial

3.

Hydrostatic
Inner Chain only

Continuous
Batch

Tinplate/Steel Can
Aluminum Can

2-piece
3-piece

Flame

5.

Other

(explain)

.

6.

Acidified
Maximum Equilibrium pH:
Method of Acidification:

Outer Chain only
Both Inner and
Outer Chain

Acidifying Agent:
Pasteurization Method:

Single Chain
Multiple Chain

Preservative Used:

. , . , .

Concentration:

CONTAINER TYPE:
1.
2.

4.

3.
4.

Welded
Cemented

Glass or Ceramic
(specify material):
Flexible Pouch

5.

Semirigid (specify material):

6.

Seal Method
Other (specify):

DATE LAST ESTABLISHED

PROCESS ESTABLISHMENT SOURCE (Limit entry to 30 characters)

Lid

Body

PROCESS RECOMMENDATIONS ATTACHED?
YES

Y

C. CRITICAL FACTORS:

Y

Y

M

NO

M

AS DELINEATED BY PROCESS AUTHORITY TO ASSURE COMMERCIAL STERILITY (Check or Describe)

None of the following ...............................................................
Maximum Water Activity (a w) ...............................................
Consistency / Viscosity ...........................................................
Value ............................................................................
Units .............................................................................
Method Name ...............................................................
Temperature .................................................................
Container Position in Retort ....................................................
Nesting of Containers ..............................................................
Fill Method (check applicable method) ....................................

NO
MW
CV

% Solids ..................................................................................
Solid to Liquid Ratio (wt. to wt.) ..............................................
Drained wt./Net wt. Ratio ........................................................

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CP
NC
FM

Hand or Volumetric ......................................................
Vibrating or Tumble .....................................................
Other (specify) .............................................................

FORM FDA 2541a (4/10)

Y

SO
SL
DW

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PREVIOUS EDITION IS OBSOLETE

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Arrangements of Pieces in Container .....................................
Formulation Changes ..............................................................
Preparation Method .................................................................
Product Quality ........................................................................
Matting Tendency ....................................................................
Layer Pack ..............................................................................
Max. Flexible Pouch/Semirigid Container Thickness in Retort
Max. Residual Air (Flexible Pouch/Semigrid Container) .........
Particle Size ............................................................................
Syrup Strength ........................................................................
Starch Added ..........................................................................
Max. % ..........................................................................
Type ..............................................................................

AP
FC
PM
PQ
MT
LP
MP
MR
PS
SS
SA

Other Binder ............................................................................
Min. % Moisture of Dry Ingredients .........................................
Other (specify) .........................................................................

OB
MM
OT

NOTE: No commercial processor shall engage in the processing of low-acid or acidified foods unless completed Forms FDA 2541 and
FDA 2541a have been filed with the Food and Drug Administration, 21 CFR 108.25(c)(1) and (2) and 108.35(c)(1) and (2).

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PSC Graphics (301) 443-1090

EF

D. SCHEDULED PROCESS
CONTAINER
DIMENSIONS
Cont. Diameter or
No.
Length

Height or
Width

(Do not write in shaded areas -- Check appropriate box and enter numerical values on dashed lines.)
CAPACITY
UNITS

Height or
Maximum
Pouch or
Semirigid
Container
Thickness

SCHEDULED PROCESS
(Check Only One in Each Column)

Oz.
Gal.
ML
Other

Min.IT

Min.IT

Center

Process
Time

Process
Temp.

N/A

N/A

Minutes

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.

Headspace

F0

Reel
Diameter

Other F Value

Steps
Per Turn
of Reel

Minimum
Net Weight

OTHER
(Specify)
Minimum
Free Liq. at
Closing

Chain /
Conveyer
Speed

Minimum
Container
Closing
Machine
Gauge
Vacuum

Feet

Death Rate (z):

Temp.
(± 3° F)

Carriers
Flights

Net

(per minute)

Gross

Drained
Fill

IS Value
N/A

Other:

°F

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.

N/A

N/A

Containers
per Minute

Inches

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N/A

RPM

.
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.
.
.
.
.
.
.

Inches Number

Inches

.
.
.
.
.
.
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.

N/A

N/A

N/A

N/A

Ounces

Ounces

Ounces

In. Hg.

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FOR FDA USE ONLY

COMMENTS:

PLANT NAME / ADDRESS

AUTHORIZED
INDIVIDUAL

PREFERRED
MAILING
ADDRESS

FORM FDA 2541a (4/10)

Maximum
Weight

Speed
Reel Speed

Ref. Temp.(T):

Hold
Time
Other

°F

Thruput

Process

Process
Temp.

Acidified or a w Controlled

Fill

Inches & Inches & Inches &
Sixteenths Sixteenths Sixteenths

Process
Time

SID:

OTHER CRITICAL FACTORS TO ASSURE
COMMERCIAL STERILITY PER SOURCE AUTHORITY

Step Temperature Process Time Sterilization Least Sterilizing Value
Temperature of the Scheduled
No.

LACF

FCE:

FULL NAME

SIGNATURE

Page 2

(Please Type or Print)

TELEPHONE NUMBER

DATE

LACF Contact Information
E-mail: LACF@FDA.HHS.GOV
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

Public reporting burden for this collection of information is estimated to average .333 hour per response, including the
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, 420A
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 control number.

FORM FDA 2541a (4/10)

Page 3

PREVIOUS EDITION IS OBSOLETE