[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR113.60]
[Page 249-252]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 113 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED
Subpart D Control of Components, Food Product Containers, Closures, and
In-Process Materials
Sec. 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:
------------------------------------------------------------------------
Required Optional
------------------------------------------------------------------------
Cover hook Overlap (by calculation).
Body hook Countersink.
Width (length, height) ......................................
Tightness (observation for ......................................
wrinkle)
[[Page 250]]
Thickness ......................................
------------------------------------------------------------------------
(b) Seam scope or projector:
------------------------------------------------------------------------
Required Optional
------------------------------------------------------------------------
Body hook Width (length, height).
Overlap Cover hook.
Tightness (observation for Countersink.
wrinkle)
Thickness by micrometer .....................................
------------------------------------------------------------------------
(c) Can double seam terminology:
[[Page 251]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.376
(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.
[[Page 252]]
(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[deg] 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. When cans are handled on belt conveyors,
the conveyors should be so constructed as 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. Automatic equipment used in handling filled containers
should be so designed and operated as to preserve the can seam or other
container closure integrity.
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