Free 2541a - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION

A. PRODUCT

FOOD PROCESS FILING FOR ALL METHODS EXCEPT LOW-ACID ASEPTIC

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

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

Name, Form or Style, and Packing Medium: pH: (Before Acidification) Governing Regulation: low-acid (21 CFR 108.35/113) acidified (21 CFR 108.25/114)

.

See Burden Statement on page 3.

20
Type of Submission: new replaces cancels
NAME OF STERILIZER (MFR. & TYPE) HEATING MEDIUM (e.g., Steam, water, immersion or spray, steam-air)

Process Use: scheduled alternate for emergency for

Y Y Y Y

M M

D D

S S S

FCE

SID

B. PROCESSING METHOD
1. Still Horizontal a. 2. b. Vertical a.

Divider Plates (complete for a. or b.) None Perforated b. c. Crateless Bottom Surface (complete for c.) Solid Perforated

Agitating End over End Axial Continuous Batch

3.

Hydrostatic Inner Chain only Outer Chain only Both Inner and Outer Chain Single Chain Multiple Chain

4.

Flame

5.

Other

(explain)

6.

Acidified Maximum Equilibrium pH: Method of Acidification:

.

Acidifying Agent: Pasteurization Method: Preservative Used: Concentration:

. , . , .
Lid Body

CONTAINER TYPE:
1. 2. Tinplate/Steel Can Aluminum Can 2-piece 3-piece Welded Cemented

3. 4.

Glass or Ceramic (specify material): Flexible Pouch

5. 6.

Semirigid (specify material): Seal Method Other (specify):

PROCESS ESTABLISHMENT SOURCE (Limit entry to 30 characters)

DATE LAST ESTABLISHED
Y Y Y Y M M

PROCESS RECOMMENDATIONS ATTACHED?
YES NO

C. CRITICAL FACTORS:

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) .................................... Hand or Volumetric ...................................................... Vibrating or Tumble ..................................................... Other (specify) ............................................................. % Solids .................................................................................. Solid to Liquid Ratio (wt. to wt.) .............................................. Drained wt./Net wt. Ratio ........................................................

NO MW CV

( ( (

.

)

. .)

)

CP NC FM

SO SL DW

( ( (

.

. .

) ) )

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

AP FC PM PQ MT LP MP MR PS SS SA

( ( ( ( (

.

. . . .

) ) c.c. ) ) )
PSC Graphics: (301) 443-1090

OB MM OT

FORM FDA 2541a (10/08)

Page 1

PREVIOUS EDITION IS OBSOLETE

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).

EF

D. SCHEDULED PROCESS
CONTAINER DIMENSIONS
Cont. Diameter or No. Length Height or Width
Height or Maximum Pouch or Semirigid Container Thickness

(Do not write in shaded areas -- Check appropriate box and enter numerical values on dashed lines.)
CAPACITY UNITS SCHEDULED PROCESS (Check Only One in Each Column)
Step Temperature Process Time Sterilization Least Sterilizing Value Temperature of the Scheduled No. Thruput Headspace Reel Speed

FCE:

SID:
OTHER (Specify)
Minimum Free Liq. at Closing Minimum Container Closing Machine Gauge Vacuum

OTHER CRITICAL FACTORS TO ASSURE COMMERCIAL STERILITY PER SOURCE AUTHORITY
Speed Reel Diameter Steps Per Turn of Reel Chain / Conveyer Speed Feet Carriers Net Gross Flights (per minute) Drained Fill N/A N/A N/A N/A Temp. (± 3° F) Maximum Weight Minimum Net Weight

LACF

Process

Oz. Gal. ML Other

Min.IT

Process Time

Process Temp.

F0 Other F Value Death Rate (z): Ref. Temp.(T): IS Value

Acidified or a w Controlled
Min.IT Fill Center N/A Process Time Hold Time Other N/A N/A Process Temp.

Other:

N/A

N/A

N/A

Inches & Inches & Inches & Sixteenths Sixteenths Sixteenths

°F

Minutes

°F

Containers per Minute

Inches

RPM

Inches Number

Inches

Ounces

Ounces

Ounces

In. Hg.

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COMMENTS:

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FOR FDA USE ONLY

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PLANT NAME / ADDRESS

AUTHORIZED INDIVIDUAL

FULL NAME

(Please Type or Print)

TELEPHONE NUMBER

PREFERRED MAILING ADDRESS

SIGNATURE

DATE

FORM FDA 2541a (10/08)

Page 2

Public reporting burden for this collection of information is estimated to average .333 hours 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 the Chief Information Officer (HFA-710) 5600 Fishers Lane Rockville, MD 20857 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 (10/08)

Page 3