• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF): Paper Submission Instructions Part III (Process Filing For All Processing Methods Except Low-Acid Aseptic (Form FDA 2541a))

Back to Paper Submissions Main Page
 

1997



All processing methods except low-acid aseptic, are filed on Form FDA 2541a. When the process method is low-acid aseptic, file on Form FDA 2541c. This section contains instructions for all processing methods except low-acid aseptic. Instructions for filing low-acid aseptic processes are contained in a separate supplement which is available on request.

For aseptically processed foods where acid is added for the purpose of reducing the heat treatment, the factor which provides the public health protection (heat or acidification) determines the filing form to be used (i.e., for a product acidified to a maximum equilibrium pH ≤ 4.6, use Form FDA 2541a; for an aseptically processed product acidified to a maximum equilibrium pH >4.6, use Form FDA 2541c).

Complete a separate process filing form FDA 2541a for:

  • Each processing method (still, agitating, hydrostatic, acidified, other, etc.). If the product is processed by more than one processing method, a separate form must be used for each method. When the product is processed by one method, but different heating media are used, a separate form must be filed for each medium.
  • Each product form or style (whole, diced, French style, strained, solid-pack, syrup strength category, brined, cream style, mature, cured, dry pack, vacuum pack, etc.) which receives a different scheduled process or when the characteristics of the food affect the heat transfer rate.

    Products having minor formulation differences or several forms or styles may be filed on the same 2541a if other factors do not require separate filing and if the same scheduled process applies to each product variation. The formulation differences (forms or styles) should be specified parenthetically after the product name.

    For example:

    • "Beans in tomato sauce (with or without pork)"
    • "Carrots (whole, cut, quartered, sliced, dried, shoestring) in brine"

    If the heat transfer rates are different, the process for the slowest heating formulation, form or style must be filed. The comment section of the form should state which formulation form or style is the slowest heating.

    In any case, mushrooms* must always be separated by product form or style (i.e., a separate form submitted for each form or style: whole, buttons, pieces and stems).

    *applies only to mushrooms (Agaricus bisporus or (A. Bitorguis) which meet the standard of identify (21 CFR 155.201).

  • Each type of container (metal, glass, flexible pouch, etc.) in which the product is packed, even though all other information is exactly the same. However, multiple container sizes of the same container type may (and should) be included on a single form for a given product, as long as the container type, packing medium, and other such information not related to container size is identical.
  • Each different packing medium (e.g., water, oil, sauces, etc.).

    Products in different packing mediums which have the same heat transfer rates and identical scheduled processes may be filed on the same form with the packing medium listed parenthetically, for example:

    • "Sardines in oil (vegetable, olive or soya)"
    • "Tuna in brine (water, vegetable broth or, sweetened brine)"
    • "Mackerel in sauce (tomato or mustard)"
  • Each process source when all scheduled processes listed were not established jointly.

The name of the product on the filing form must include all combinations of form or style and packing medium which will appear on product labels and shipping documents. Some products may also have qualifying terms which identify and separate different species, processing methods or organoleptic or visual properties. For example:

  • "Sardines (Sild, Brisling, Smoked) in oil (vegetable, olive, soya)"
  • "Jalapeno Peppers (Red and Green) in brine"
  • "Clam Chowder (New England, Manhattan)
  • "Radishes, pickled (Szechuan, Hunan) in brine"
  • "Tuna (light, dark, albacore) (chunk, flake) in oil (vegetable, olive, soya)"

When the name of the product on the label is in both English and a foreign language, especially when the English name may not separately identify similar products, the foreign language name should be listed parenthetically. For example: "mixed vegetables, pickled (matsutake meshi-no-moto, mishmemo-moto) in brine"

  • "Vegetarian Chop Suey (Lo han Chai, Szu Hsien Kaw Fu)"

NOTE: In all cases, put the name of the product first, followed by the appropriate descriptive terms the form(s) or style(s) second and the packing medium third. For example:

"Sardines, smoked in oil" not "Smoked sardines in oil"

A separate form is not required for each brand name of the product as long as the scheduled process for these brands is exactly the same. The brand name should not be listed on the filing form unless it is necessary to identify different products having different scheduled processes.

In order to reduce the time needed to complete the form, the use of photocopies or similar reproductions of forms with only slight variations (e.g., all processing information is identical for several different products) is acceptable, as long as each bears a unique submission identifier (SID) and is signed by an authorized company representative.

Also, if a sufficient number of forms is not available, the use of photocopies or other reproductions is acceptable. An extra copy should be made to keep in the processor's files.

Complete each required space on the form in English according to the instructions which follow. The following sections numbers in parentheses correspond to numbers in blocks shown on the sample form on pages 54-55.

 

PART A. PRODUCT:

  1. FCE

    Enter the 5-digit Food Canning Establishment (FCE) Number assigned to your establishment by the FDA when you registered (from Form FDA 2541). If registering concurrently with initial process filing, leave blank (FDA will complete). Upon receipt of your FCE number from FDA, record it on your copies of process filing forms.

  2. Submission Identifier (SID)

    Enter a different SID on each process filing form as follows, based on the date the form is being submitted:

    YYis the last two digits of the year (e.g., 96, 97, 98, etc.)
    MMis the numerical designation of the month (e.g., 05 for May, 10 for October, etc.)
    DDis the day of the month (e.g., 03, 28, etc.)
    SSSis a unique sequence number within the date (e.g., 001, 002, etc.)

    (SID's can be entered on forms submitted concurrently with registration).

  3. Name, Form or Style, and Packing Medium

    Enter the food product name, form or style, and packing medium in that order, e.g., Carrots (whole) in water; Mushrooms (sliced) in gravy; etc.

    Product forms or styles receiving the same scheduled process should be included in parentheses after the product name. For example, "Carrots (whole, cut, quartered, sliced, diced, or shoestring) in brine".

    REMEMBER:

    • Each different packing medium (e.g., water, oil, sauce, etc.) must be filed on a separate form. Products packed in water, brine, and sweetened brine may be filed on the same form as long as the scheduled processes are exactly the same.
    • Each different form or style of mushrooms must always be filed on separate forms. For example:
      • Mushrooms, Whole
      • Mushrooms, Buttons
      • Mushrooms, Sliced; and
      • Mushroom, pieces and stems.
    • Foreign Firms:

      • List the English name as well as the non-English name if it appears on the label. For example:

        Green kidney beans (flageolets) in brine

  4. Raw pH

    Enter the normal or natural pH of the product before processing, to the nearest tenth (e.g., 6.5). For acidified products, enter the highest natural pH of the low-acid component(s)(the component(s) or ingredient(s) having a pH value(s) greater than 4.6).

  5. Governing Regulation

    Place a mark by the governing regulation under which the process is being filed (i.e., whether the product is low-acid or acidified).

  6. Type of Submission

    Mark "new" if no previous processes have been filed for this product in the container sizes being listed or if these are additional processes for the container sizes listed (i.e., this form does not replace a previously submitted form).

    Mark "replaces" if this is a replacement for a previously submitted process filing form, and enter the SID of the previously filed form being replaced.

    Mark "cancels" if you are canceling a previously filed form (not replacing it with another). Enter the SID of the previously filed form being canceled and the product name (this is an aid in ensuring cancellation of the correct form). Complete the information at the bottom of the form (29) and (30); sign and date it, and send it to FDA.

    As an alternative, you may summit a copy of the form to be canceled. Assign a new SID in (2) (lining out the original one without making it unreadable), check "cancels" in (6) and enter the original SID. Sign and date the photocopy above the original signature and date and submit it to FDA.

    If you wish to delete one or more container sizes previously filed, submit a "replacement" for the previously filed form, listing only the container sizes currently applicable.

  7. Process Use

    Check "scheduled" if this is the process used regularly for this product under normal conditions.

    Check "alternate" if this is a process used regularly in lieu of the ordinarily used (scheduled) process (which is filed separately). Enter the SID of the scheduled process for which this is an alternate. If you are replacing a scheduled process for which you have filed alternate processes, FDA will assume that the alternate processes apply to the replacement scheduled process. If the alternate processes do not apply to the replacement, they should be replaced or canceled by separate submissions. With the advent of computer technology, multiple alternate processes may be established. If these processes are not used regularly, these need not be filed with FDA. However, process recommendations from the organization or person who established the processes must be kept in the plant files, if used.

    Check "emergency" if this is an emergency still process for a separately filed (scheduled) agitating process, and enter the SID of the applicable scheduled agitating process.

 

FORMS RETURNED BY FDA CLARIFICATION OR FOR MISSING DATA

When resubmitting a form which was returned by FDA for missing data, enter the missing data directly on the returned form and send it to FDA.  DO NOT CHANGE THE SID OR TYPE OF SUBMISSION. Be sure to enter the missing data on your file copy of the form.

 

 

PART B. PROCESSING METHOD:

  1. Name of Sterilizer/(Autoclave) (Manufacturer & Type)

    Enter the name of the manufacturer and the model number or name (if applicable). Limit to 30 characters when possible. Abbreviations may be used when meanings are clear. Do not use the words still, agitating, hydrostatic, flame in the sterilizer name. For still retorts do not enter vertical or horizontal in the sterilizer name. This information is requested as part of the form under B. Processing Method.

    Heating Medium Enter the common description of the heating medium (e.g., steam, water immersion, water cascade, water spray, steam-air or other).

  2. Mark the processing method used, (one method per form) and provide the additional information indicated below:
    If you check:Also provide the following:
    STILLMark horizontal, vertical, or crateless. Indicate whether divider plates are solid or perforated or check "none", if applicable. For crateless retorts, indicate the applicable bottom surface. Mark solid or perforated.
    AGITATINGMark the agitation method (end over end or axial). Mark continuous or discontinuous. Continuous refers to systems which convey containers into and out of the sterilizer. Batch refers to systems which rotate baskets of containers during processing but do not convey containers in and out of the sterilizer.
    If you mark:Also provide the following:
    HYDROSTATICType of chain conveyor (inner only, outer only, both, etc.).
    FLAMEN/A
    OTHERFully describe the type of equipment used. Sterilizers using steam/air, water cascade or water spray should be marked "other". Processes based on water activity or salt control should be marked "Other".
  3. Acidified Products

    If 21 CFR 108.25 and 114 was marked as the governing regulation, mark "acidified" and complete all applicable information as follows:

    • Maximum Equilibrium pH

      Enter the maximum equilibrium pH (upper limit) of the finished product after acidification, measured within 24 hours after processing, to the nearest tenth (e.g., 4.2). Recheck Section A. Product to assure that the raw pH (Item (4)) was also completed properly.

    • Method of Acidification

      Enter the method of acidification (e.g., direct acidification, acid blanch, acid soak, etc.). If direct acidification is used, enter the concentration of acid immediately below. The concentration should be entered as the % of the final product. Other ways of stating concentration should be entered in the comments section or by attachment to the form.

    • Acidifying Agent

      Enter acidifying agent(s), e.g., citric, acetic, malic, fumaric, tomato sauce, tartaric, etc.

    • Pasteurization Method

      If a heat treatment (e.g., pasteurization) is recommended by the process source as part of the scheduled process, enter the type of treatment, such as water bath, hot fill hold, steam tunnel, etc. If a heat treatment is not specified by the process source as part of the scheduled process (i.e., pH control only), enter N/A.

    • Preservative Used

      If a preservative is used along with pH control, specify the preservative (e.g., sodium benzoate, potassium sorbate, etc.) and the concentration (%) of the finished product. If no preservative is used, enter N/A.

  4. Container Type

    NOTE: Except for tinplate/steel and aluminum cans (which may be submitted on the same form if the processes are identical), USE A SEPARATE FILING FORM FOR EACH DIFFERENT CONTAINER TYPE EVEN IF ALL OTHER INFORMATION IS THE SAME.

    Mark the container type used (i.e., Tinplate/Steel Can, Aluminum Can, Glass or Ceramic, Pouch, Semi-rigid Container, or Other) and provide the additional information indicated on the following table:

    If you mark:Also provide the following:
    Tinplate/Steel or AluminumMark 2-piece and 3-piece AND whether welded, soldered, and/or cemented. NOTE: 2-piece and 3-piece cans may be filed on the same form provided that the processes being filed are adequate for the worst condition (i.e., divider plates are used between container layers or a particular stacking pattern is described demonstrating prevention of nesting). Otherwise, 2-piece and 3 piece cans must be filed separately. When nesting is specified as a critical factor by the process establishment source, it must be reflected inSection C (critical factors). When cans may nest and are not separated by dividers, please provide, in the comments section or by attachment to the form, an explanation of how nesting was considered during process establishment; otherwise explain how nesting is prevented. If nesting was considered in process establishment do not check nesting as a critical factor.
    PouchMaterial from which constructed (e.g., polyethylene/aluminum foil laminate).
    Semi-rigid ContainerType (cups, tubs, cartons, etc.) and material from which the lid and body are constructed. Specify seal method for example (double seam, heat seal and others).
    Other

    Specify the type and, if not clearly indicated by the type of container, the material from which constructed.

    NOTE: Minor container material variations that do not affect the scheduled process do not require submission of separate forms.

  5. Process Establishment Source

    NOTE: If more than one process source is listed, the process(es) must have been established jointly by the listed sources. Otherwise, use a separate form for each process source.

    Enter the name of the process source (organization, company, or individual, etc.) which scientifically established the scheduled process(es) (refer to 21 CFR 113.83 and 114.83) and the type of document containing the process recommendations (i.e., letter, bulletin, etc.). Use the following guidelines in making entries:

    • Limit entries to 30 characters,
    • If the process was established by your firm, enter your firm's name.
    • For universities, enter name of university followed by the name of an individual (if appropriate).

    Date Last Established

    Enter the last two digits of the year (in the spaces over "YY") and the numerical designation of the month (e.g., 05 for May, 10 for October, etc. in the spaces over "MM") of the most recent document issued by the process source.

    Process Recommendations Attached?

    If you are attaching a copy of the process recommendation from the process establishment source, check "YES". Otherwise check "NO". Attached documents must be in English. The process source document should also be kept on file at the processing location. Submission of process recommendations while not required, may provide sufficient information to FDA to prevent unnecessary returns of filing forms for clarification or addition.

 

PART C. CRITICAL FACTORS

  1. Mark (x) for ALL critical factors (see definition in Section V critical to the delivery of the scheduled process. If none were specified, Mark (x) "None of the Following". Where applicable, enter the appropriate value or other additional data specified as follows:

    Maximum Water Activity (aW)

    Enter value to the nearest hundredth (e.g., .88) if reduced water activity is critical to the delivery of the scheduled process. If water activity is a critical factor, provide an attachment addressing the method of analyses, the instrument used and data obtained on actual production samples. In addition, if the aw is 0.91 or higher, evidence must also be attached to demonstrate the control of microorganisms of public health significance.

    Consistency/Viscosity (if critical, complete in full)

    • Value:

      • Enter the maximum consistency reading, measured to the nearest thousandth (e.g., 85.000), at the temperature specified by the process source. If consistency is given by the process source as a range, report the value representing the most viscous or thickest product.

      Units:

      • Enter units in which reading is measured. Abbreviate as shown below. For example:

        CPS - centipoise
        C/S - centimeters/second
        INS - inches

      Method Name:

      • Enter instrument used and its characteristics. Limit to 30 characters, if possible. If more information is necessary, use the Comments section. When the Brabender method is used, include the paddle description (e.g., Brabender Paddle A).

      Temperature:

      • Enter the product temperature the reading is to be taken, to the nearest whole degree (e.g., 180) (+ 2F is assumed). If temperature is specified by the process source as a range, you may enter the range in the comments section.

      Container Position in Retort

      • Mark and describe position (horizontal, vertical, invert top down).

      Nesting of containers.

      • If nesting has not been evaluated for containers during process establishment, enter an "x" and if divider plates between container layers are not used explain in the Comment section and/or by attachment, how nesting is prevented. Include photographs or diagrams, if necessary. If nesting was considered during process establishment do not enter an "x" and provide an entry in the Comment section explaining how nesting was tested.
      Nesting of containers

      Fill Method

      • Check applicable method; if "Other" is checked, enter method on line provided.

      % Solids

      • Enter the maximum percentage, to the nearest tenth (for example, 75.5 would be entered for the maximum solid (bean) portion (weight) of a bean in brine product).

      Solid to Liquid Ratio (wt. to wt.)

      • Enter the maximum ratio of solids to a unit of liquid (to the nearest tenth), using the same units of weight for both (e.g., 02.6).

      Drained wt./Net wt. Ratio

      • Enter the maximum ratio of drained weight to a unit of net weight (to the nearest hundredth), using the same units for both (e.g., 0.79). This value cannot exceed 1.0.

      Arrangement of Pieces in Container

      • Enter the required arrangement of food components (for example, tips up).

      Formulation Changes

      • Mark if specified as critical to assure commercial sterility by the process source.

      Preparation Method

      • Mark if specified as critical to assure commercial sterility by the process source.

      Product Quality

      • Mark if specified as critical to assure commercial sterility by the process source.

      Matting Tendency

      • Mark if specified as critical to assure commercial sterility by the process source.

      Layer Pack

      • Mark if specified as critical to assure commercial sterility by the process source (e.g., weight of cream in oz. for layer packed cream style corn).

      Max. Flexible Pouch/Semirigid Thickness in Retort

      • Enter maximum thickness (in the retort during processing) in inches (to the nearest hundredth), e.g., 0.92. (Note: The maximum thickness may be controlled by the dimensions of the racking system employed.)

      Max. Residual Air (Flexible Pouch/Semirigid Container)

      • Enter the maximum residual air in cubic centimeters (cc) (to the nearest tenth), e.g., 04.2.

      Particle Size

      • Enter maximum and/or minimum particle size (e.g., "cuts > 1/4 inch"; shrimp sizes such as "small"; "minimum slice thickness 3/16 inch"; fish ball "maximum diameter 3/4 inch"; stuffed pasta tube; "maximum 2 inch length by 1/2 inch diameter" etc.) and the food component(s) to which the limitation applies.

      Syrup Strength

      • Enter maximum degrees (Brix) to the nearest tenth of a degree (e.g., for the product "sweet potatoes, syrup pack (20° Brix or less)", enter the value 20.0).

      Starch Added

      • Enter the maximum percentage, to the nearest tenth (e.g., 10.1) and the type of starch.

      Other Binder

      • Specify the binder (other than starch) and maximum amount % (e.g., for textured vegetable protein enter "TVP, maximum 1%".

      Min. % Moisture of Dry Ingredients (e.g., pasta, rice and other)

      • Enter the minimum percentage, to the nearest tenth (e.g., 32.2) in the spaces provided.

      Other

      • If a critical factor which is not listed in either Part C or D of the form (and which does not vary by container size) has been specified by the process source, enter that critical factor, along with the appropriate maximum or minimum value (if applicable). For example, full parchment liner, air cooled, maximum particle count, minimum % salt in the aqueous (water) phase, etc. and provide the critical value.

 

PART D. SCHEDULED PROCESS

  1. FCE and SID

    Enter the same FCE and SID as were entered in (1) and (2) at the top of the form (so that if the completed form is copied, the upper and lower parts of the copies can be correctly matched).

  2. Container Dimensions

    Enter the dimensions of each container size which is used for the product listed IN ENGLISH UNITS (inches and sixteenths) as described below.  Forms submitted without conversion to English units will be returned. See Appendix A. Use a separate line for each different container size and its process parameters or characteristics, numbering each line sequentially (1, 2, etc.) in the "Cont. No." column.  Do not leave blank lines between container sizes.

    For cylindrical containers, list diameter x height; for example, 0211 x 0400 for a 2 11/16 inch x 4 inch container.

  3. Cylindrical Container



    Proper Measuring Techniques for Cylindrical Containers

    When measuring unusually shaped cylindrical containers, always measure the widest part of the container. The measurements must be from the outside edge of the container.

  4. Correct Measuring - Glass Jars: Measure the largest diameter

    Correct Measuring - Oval Can

    Correct Measuring - Cylindrical Container: Measure can from edge to edge (outside)


     

    For rectangular containers (including trays), list length (longest dimension) x width (second longest dimension) x height; for example, 0405 x 0301 x 0014 for a container which is 4 5/16 inches long, 3 1/16 inches wide, and 14/16 of an inch. For other container shapes, enter the largest dimension first, the second dimension next and the smallest dimension last.


    A Rectangular Container

    Rectangular Container


    A Rectangular Tray

    Rectangular Tray


    A Low Profile Rectangular Container

    Low Profile Rectangular Container


     

    For heat sealed semirigid and flexible containers,

    enter length (longest dimension, excluding heat seal) in the first column following container number, width (second longest dimension, excluding heat seal) in the second, and maximum container thickness (in retort during processing) in the third. See illustration below. (Note: Where applicable, the maximum thickness may be controlled by the dimensions of the racking system employed).

    Form 2541a D. Scheduled Process

    Unconventional or Irregularly Shaped Containers

    When one or more of the above dimensions cannot be used, show the units in which volume is measured immediately under "Capacity Units" (in the fifth column heading). Check one of the units shown (or enter appropriate unit under "other"). Enter the volumetric capacity of each container (expressed in those units) in the boxes in the same column.

 

SCHEDULED PROCESS

For each container size identified in 15 above, enter the scheduled process information specified by the process source. Check only one item in each column under the appropriate heading ("LACF" or "Acidified or aW Controlled") unless otherwise indicated.

For multiple step processes (in which more than one sterilizer shell is used and temperatures of the sterilizer shells used are different), see special instructions under that heading on page 48.

For hydrostatic processes in which infeed and exit leg times and temperatures are a part of the process, see special instructions under that heading on page 51.

For all other processes, continue below.

  1. Step No.

    Enter "1" unless:

    • This is a multiple step process (see instructions under that heading on page 48).
    • This is a hydrostatic process in which infeed and exit leg times and temperatures are a part of the process (see special instructions on page 51).
  2. Temp (°F)

    For LACF processes, check "Min. IT" (Minimum Initial Temperature) in the heading and enter temperature of the contents of the coldest container to be processed (after thorough stirring or shaking of the filled container) at the time the sterilizing cycle begins. Express in °F to the nearest whole degree (e.g., 160).

    For Flame Sterilizers, enter product temperature at entry to holding section (that area throughout which the temperature is uniform).

    For Acidified or aW controlled LACF processes, check "Min IT", "Fill", or "Center" (whichever is applicable) and enter that temperature (in °F) if any of the above have been specified by the process establishment source. If none are applicable, enter "N/A".

  3. Process Time (Minutes)

    For LACF processes, check "Process Time" in the heading and enter the minimum process time in minutes, to the nearest hundredth of a minute (e.g., 023.90).

    For Flame Sterilizers, enter the minimum time the container is in the holding section

    For Acidified or aW controlled LACF processes, check "Process Time" "Hold Time", "Sterilizer", or "Other" as applicable, and enter the time in minutes to the nearest hundredth if any of the above have been specified by the process establishment source. If "Other" is checked, explain in the Comments section. If none of these are applicable, check "N/A".

  4. Sterilization Temp (°F)

    For LACF processes, check "Process Temp" in the heading and enter the minimum processing temperature in °F to the nearest whole degree (e.g., 260).

    For Flame Sterilizers, enter minimum temperature of the container contents through the holding section.

    For Acidified or aw controlled LACF processes check "Process Temp" and enter the minimum process temperature in F to the nearest whole degree if a sterilizer processing temperature has been specified by the process establishment source. Otherwise, check "N/A".

  5. Least Sterilizing Value of the Scheduled Process

    Check appropriate item in the heading to identify the value entered for each container number.

    • If "Fo" is checked, express the value to the nearest tenth of a minute (e.g., 015.0).

      If "Other F Value" is checked, enter the value for each process and specify the death rate (z) and reference temperature (T) in whole degrees Fahrenheit in the spaces provided.

      If "IS Value" is checked, enter the applicable Integrated Sterilizing Value on each line.

      If "Other" is checked, indicating that an equivalent scientific basis for process adequacy is applicable, enter that basis on the line provided immediately following "other".

      For acidified LACF processes wherein a heat treatment is not specified as part of the scheduled process, check "Other" and enter "N/A" in the blank space.

 

OTHER CRITICAL FACTORS TO ASSURE COMMERCIAL STERILITY PER SOURCE AUTHORITY

For each container size identified in (15) enter the scheduled process information specified by the process source as indicated below. If a factor is not specified by the process source or is specifically indicated as being not applicable, check "N/A".

  1. Thruput

    For continuous systems (continuous agitating, hydrostatic, flame, or any other "non-batch" system), enter the maximum thruput allowable if specified by the process source. Express in whole containers per minute (e.g., 0235).

    • For Flame Sterilizers, enter the maximum thruput allowable through the holding section.
  2. Headspace

    If the process source has specified that minimum headspace be controlled in order to assure delivery of the scheduled process, check appropriate space in column heading to indicate whether "Net" or "Gross" headspace is given. Enter the minimum headspace in inches to the nearest ten thousandth (e.g., 0.3750). If minimum headspace is not applicable, check "N/A".

  3. Speed

    For all continuous systems and batch agitating systems, provide the information specified below. For still processes, check "N/A".

    Reel Speed

    • Agitating Systems

      Express in revolutions per minute (RPM), to the nearest hundredth of a revolution (e.g., 035.40). For continuous agitating retorts enter the RPM for the process time filed and enter the minimum RPM under "Other (Specify)". Under the heading "Other (Specify)" enter "Min. RPM" and enter the value(s) on the appropriate row for each process. If the process was established at "O" RPM enter descriptive information in the Comments section.

      Other Systems

      Leave Blank.

  4. Reel Diameter

    Agitating Systems

    Express in whole inches (e.g., 050).

    Other Systems

    Leave Blank.

    Steps Per Turn of Reel

    • Agitating Systems

      Enter the number of container positions around the circumference of the reel.

      Other Systems

      Leave Blank.

    Chain/Conveyor Speed

    • Agitating Systems

      Leave Blank

      Hydrostatic Systems

      Check applicable space in column heading to indicate whether speed is expressed in feet per minute, carriers per minute, or flights per minute. Express value to the nearest hundredth (e.g., 063.30).

    Flame Systems

    Check "Feet per minute" space in column heading and enter the value to the nearest hundredth (e.g., 005.25).

  5. Maximum Weight

    If the process source has specified that maximum fill weight or maximum drained weight must be controlled in order to assure delivery of the scheduled process, check the applicable space in the column heading and enter the maximum weight in ounces, to the nearest hundredth (e.g., 03.10). If not applicable, check "N/A".

  6. Minimum Net Weight

    If the process source has specified that minimum net weight must be controlled in order to assure delivery of the scheduled process, enter the minimum net weight in ounces, to the nearest hundredth (e.g., 08.25). If not applicable, check "N/A".

  7. Minimum Free Liquid at Closing

    FOR VACUUM PACK PROCESSES ONLY, enter the minimum free liquid in the container (in ounces) at closing, as specified by the process source. Express to the nearest tenth (e.g., 01.3). If not applicable, check "N/A".

  8. Minimum Container Closing Machine Gauge Vacuum

    FOR VACUUM PACK PROCESSES ONLY, enter minimum container closing machine gauge vacuum if specified by the process source to be critical to the delivery of the scheduled process. Express in whole inches of mercury (Hg). In the column heading, enter the temperature at which measured (as specified by the process source). If not applicable, check "N/A".

  9. Other

    If any other critical factors whose values vary by container size have been specified by the process source as critical to the delivery of the scheduled process(e.g., minimum RPM, minimum come-up time), identify them in the column heading under "OTHER", and enter the applicable values on the appropriate line.

    For Low Acid Foods acidified to a maximum equilibrium pH above 4.6 for the purpose of reducing the thermal process, the maximum pH is then considered a critical factor to be listed under this section.

    This space may also be used to indicate the hydrostat chain(s) to which the process applies by entering a column heading of "chain" and entering "I" for inner,"O" for outer, etc. on the applicable line. Limit entries to five characters for each process.

  10. Comments

    You may use this space to enter any comments which you believe are necessary to clarify any entries on this form.

  11. Plant Name and Address

    Enter the name of your plant and its location address, corresponding to the FCE Number entered in (1) and (14) above. This is used by FDA as a check of the FCE number and may not be used to change the name or address. Name and address changes must be submitted on an Establishment Registration form (FDA 2541). Also, enter the preferred mailing address, if used.

    An address change resulting from a move to a different location (as opposed to a street name change, etc.) requires re-registration (and assignment of a new FCE number) and re-filing of all scheduled processes. The old FCE number is not valid and its use will not be accepted by FDA.

    Authorized Individual

    Print (or type) the name of the authorized representative who is signing this form on behalf of the company, and the area code and telephone number at which she or he can be reached. Sign and date the form and mail the original copy to:

    LACF Registration Coordinator (HFS-618)
    Center for Food Safety and Applied Nutrition (FDA)
    5100 Paint Branch Parkway
    College Park, MD 20740-3835

    If someone other than an employee or officer of your company signs the form, FDA must have on file, a letter from your company authorizing this person or organization to act on your behalf.

    Keep the second (pink) copy for your files. You are required to maintain a file copy for future reference at the processing plant location.

If you have any questions about any of these instructions, contact FDA at the above address, telephone (301) 436-2411 or by Internet to LACF@CFSAN.FDA.GOV.

 

 

MULTIPLE STEP PROCESSES

If more than one sterilizer shell (other than cooling) is used in continuous processes and the temperatures of these shells are different (multiple step processes), report the data for each container number as indicated below. refer to the appropriate headings (identified by boxed numbers) for detailed explanations of the data requirements for each item. An example of a multiple step process is shown on the facing pages 54-55.

  1. For the first shell (or preheater) of container number 1, enter "1" in the "Step No." column, and provide the following information for that shell as explained under the appropriate heading. If a particular factor is not applicable according to the process establishment source, check "N/A" in the applicable column.
    • Minimum Initial Temperature (Min. IT) (see (17))
    • Minimum Process Time (Process Time) (see (18))
    • Minimum Processing Temperature (Process Temp) (see (19))
    • Thruput (see (21))
    • Headspace (see (22))
    • Speed (including reel speed, reel diameter, and steps per turn of reel OR Chain/Conveyor speed) (see (23))
    • Maximum Weight (drained or fill) (see (24))
    • Minimum Net Weight (see (25))
    • Minimum Free Liquid at Closing (see (26))
    • Minimum Container Closing Machine Gauge Vacuum and temperature at which measured (see (27))
  2. For the second shell, enter "2" in the "Step Number" column and the following additional information for the second shell:
    • Minimum Initial Temperature (if applicable) (see (17))
    • Minimum Process Time (see (18))
    • Minimum Processing Temperature (see (19))
    • Thruput (see (21))
    • Speed (see (23))
  3. Describe each shell for this container size in the same manner, assigning each the next sequential step number. Enter the "Least Sterilizing Value of the Scheduled Process" (see (20) ) only on the last line for each container size.
  4. For the second container size, enter "2" in the container number column and the container dimensions in the appropriate columns. Enter required information as instructed in 1.above. Follow 2. and 3. above for the second container size. Repeat for each subsequent container size.
  5. Complete items 28 and 30 and item 29, if applicable.

AN EXAMPLE OF A COMPLETED SECTION

An Example of a Completed Section of Form FDA 2541a

 

 

SPECIAL INSTRUCTIONS FOR HYDROSTATIC PROCESSES IN WHICH INFEED AND EXIT LEG TIMES AND TEMPERATURES ARE A PART OF THE PROCESS

For such processes, report the data as follows (see example on page 53). The encircled numbers correspond to the detailed explanation of the data requirements for each item.

  1. Enter the container number and container dimensions for the first container (see 15). On the same line, enter "F" in the "Step No." column (16) to indicate Feed leg. Continuing on the same line, enter:
    • Minimum initial temperature of the product at entry to infeed leg under "Temp" (Min. IT) ((17))
    • Infeed leg time under "Process Time" ((18))
    • Infeed leg temperature under "Sterilization Temp" ((19))
  2. On the next line, enter "S" in the "Step No." column (16)) to indicate Steam chamber. Do not repeat container number or dimensions. Continuing on the same line, enter the following. If a factor is not applicable per the source authority, check "N/A" in that column.
    • Minimum process time in the steam chamber under "Process Time" ((18))
    • Steam chamber temperature under "Sterilization Temp" ((19))
    • Thruput in whole containers per minute (if applicable) ((21))
    • Headspace ((22))
    • Chain or conveyor speed under that column heading ((23))
    • Maximum weight under that column heading ((24))
    • Minimum net weight under that column heading ((25))
    • Minimum free liquid at closing under that column heading ((26))
    • Minimum container closing machine gauge vacuum under that column heading ((27))
    • Other critical factors specified by the source authority under "OTHER" ((28))
  3. On the next line, enter "E" for Exit in the "Step No." column ((16)). Do not repeat container dimensions. Continuing on this line, enter the following:
    • Exit leg time under "Process Time" ((18))
    • Exit leg temperature under "Sterilization Temp" ((19))
    • The least sterilizing value of the total scheduled process (Fo) under that column heading ((20))
  4. For the second container size enter "2" in the container number column on the next available line ((15)) along with the container dimensions. Continue as in l., 2., and 3. above for the second container size. Repeat for each subsequent container size in the same manner.

AN EXAMPLE OF A COMPLETED SECTION

An example of a completed section of FDA Form 2541a

An example of a completed section of FDA Form 2541a


An example of a completed section of FDA Form 2541a