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e-CFR data is current as of April 9, 2021

Title 21Chapter ISubchapter BPart 113 → Subpart D

Title 21: Food and Drugs

Subpart D—Control of Components, Food Product Containers, Closures, and In-Process Materials

§113.60   Containers.

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§113.60   Containers.

(a) Closures. Regular observations shall be maintained during production runs for gross closure defects. Any such defects shall be recorded and corrective action taken and recorded. At intervals of sufficient frequency to ensure proper closure, the operator, closure supervisor, or other qualified container closure inspection person shall visually examine either the top seam of a can randomly selected from each seaming head or the closure of any other type of container being used and shall record the observations made. For double-seam cans, each can should be examined for cutover or sharpness, skidding or deadheading, false seam, droop at the crossover or lap, and condition of inside of countersink wall for evidence of broken chuck. Such measurements and recordings should be made at intervals not to exceed 30 minutes. Additional visual closure inspections shall be made immediately following a jam in a closing machine, after closing machine adjustment, or after startup of a machine following a prolonged shutdown. All pertinent observations shall be recorded. When irregularities are found, the corrective action shall be recorded.

(1) Teardown examinations for double-seam cans shall be performed by a qualified individual and the results therefrom shall be recorded at intervals of sufficient frequency on enough containers from each seaming station to ensure maintenance of seam integrity. Such examinations and recordings should be made at intervals not to exceed 4 hours. The results of the teardown examinations shall be recorded and the corrective action taken, if any, shall be noted.

(i) Required and optional can seam measurements:

(a) Micrometer measurement system:

Cover hookOverlap (by calculation).
Body hookCountersink.
Width (length, height)
Tightness (observation for wrinkle)

(b) Seam scope or projector:

Body hookWidth (length, height).
OverlapCover hook.
Tightness (observation for wrinkle)Countersink.
Thickness by micrometer

(c) Can double seam terminology:

eCFR graphic er01ja93.376.gif

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(1) “Crossover”: The portion of a double seam at the lap.

(2) “Cutover”: A fracture, sharp bend, or break in the metal at the top of the inside portion of the double seam.

(3) “Deadhead”: A seam which is incomplete due to chuck spinning in the countersink.

(4) “Droop”: Smooth projection of double seam below bottom of normal seam.

(5) “False seam”: A small seam breakdown where the cover hook and the body hook are not overlapped.

(6) “Lap”: Two thicknesses of material bonded together.

(ii) Two measurements at different locations, excluding the side seam, shall be made for each double seam characteristic if a seam scope or seam projector is used. When a micrometer is used, three measurements shall be made at points approximately 120° apart, excluding the side seam.

(iii) Overlap length can be calculated by the following formula:

The theoretical overlap length = CH + BH + T − W, where

CH = cover hook

BH = body hook

T = cover thickness, and

W = seam width (height, length)

(2) For glass containers with vacuum closures, capper efficiency must be checked by a measurement of the cold water vacuum. This shall be done before actual filling operations, and the results shall be recorded.

(3) For closures other than double seams and glass containers, appropriate detailed inspections and tests shall be conducted by qualified personnel at intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable hermetic seal production. Records of such tests shall be maintained.

(b) Cooling water. Container cooling water shall be chlorinated or otherwise sanitized as necessary for cooling canals and for recirculated water supplies. There should be a measurable residual of the sanitizer employed at the water discharge point of the container cooler.

(c) Coding. Each hermetically sealed container of low-acid processed food shall be marked with an identifying code that shall be permanently visible to the naked eye. When the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, if the label is securely affixed to the product container. The required identification shall identify in code the establishment where packed, the product contained therein, the year packed, the day packed, and the period during which packed. The packing period code shall be changed with sufficient frequency to enable ready identification of lots during their sale and distribution. Codes may be changed on the basis of one of the following: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift.

(d) Postprocess handling. Container handling equipment used in handling filled containers shall be designed, constructed, and operated to preserve the can seam or other container closure integrity. Container handling equipment, including automated and non-automated equipment, shall be checked with sufficient frequency and repaired or replaced as necessary to prevent damage to containers and container closures. When cans are handled on belt conveyors, the conveyors should be constructed to minimize contact by the belt with the double seam, i.e., cans should not be rolled on the double seam. All worn and frayed belting, can retarders, cushions, etc. should be replaced with new nonporous material. All tracks and belts that come into contact with the can seams should be thoroughly scrubbed and sanitized at intervals of sufficient frequency to avoid product contamination.

[44 FR 16215, Mar. 16, 1979, as amended at 76 FR 11922, Mar. 3, 2011]

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