concerning the procedures for testing metal cans and glass
jars but very little for plastic containers. For instance,
FDA regulations in Part 113.60 (a) (3) of 21 CFR only state
that for closures other than double seams and glass
containers, appropriate inspections shall be conducted
and tests be made by qualified personnel at intervals of
sufficient frequency to ensure proper closure machine
performance and consistently reliable hermetic seal pro-
duction. Records of tests shall be maintained.
The USDA-FSIS regulations described in Part 381.301
(d) (1) and Part 318.309 (d) of 9 CFR include more specific
details on the evaluation of semirigid and flexible contain-
ers, such as visual test, physical test, and incubation test.
The regulations require that heat seals and the entire
container be visually inspected before and after thermal
processing operation by a trained closure technician with
sufficient frequency and that corrective actions be promptly
recorded; that physical test be performed after thermal
processing operation by a trained closure technician at
sufficient frequency (at least once every 2 h recommended)
and that corrective actions be promptly recorded; and that
at least one finish container per batch be incubated for not
less than 10 days at 95751F. In addition, the USDA-FSIS
requires that empty containers, closures, and container
rollstock be inspected, stored, handled, and conveyed in a
manner to ensure they are clean and free of defects that
may affect the product or package integrity.
Processors who pack product in flexible pouches under
military contract are also required to comply with specific
U.S. military contract requirements (8, 9). A 100% visual
inspection of the seals on every pouch produced may be
required both before and after thermal processing. Other
requirements are (a) destructive tests in which sample
pouches must withstand internal pressure at 20 psig for
30 s (burst test), (b) residual gas tests (o10 mL), and (c)
incubation tests after thermal processing for not less than
10 days at 80–951F.
In response to requests by industry to evaluate contain-
ers and closures, the Food Products Association (FPA, the
former NFPA), in joint efforts with FDA, USDA, and
industry, developed guidance documents that (a) provided
a classification of visual exterior defects of flexible and
semirigid containers, (b) established the relative hazard of
each defect to public health, and (c) defined sampling rates
and action levels for the various defects in flexible and
semirigid containers (10, 11). In addition, FDA published
the Bacteriological Analytical Manual (BAM) that con-
tains a chapter entitled, ‘‘Examination of Containers for
Integrity’’ (12). This chapter describes procedures for the
examination of paperboard packages, flexible pouches,
plastic cups and trays with flexible lids, and plastic cans
with double-seamed metal ends. Test procedures included
are air leak testing, bio-testing, burst testing, chemical
itching, compression testing, distribution test, dye pene-
tration, electester, electrolytic, gas leak detection, incuba-
tion, light, machine vision, proximity tester, seam scope
projection, sound, tensile testing, vacuum testing, and
visual inspection. The manual, however, doesn’t reflect
current advances in inspection techniques for container
integrity.
SPECIAL CONSIDERATIONS FOR EMERGING INSPECTION
TECHNOLOGIES
Inspection techniques for detecting package defects in
the food industry have been moving toward nondestruc-
tive and online methods that test all packages. The
applicability of these emerging inspection techniques to
various food containers with different types and composi-
tions has become of great interest to the industry.
In spite of rapid advances in technologies, however,
severe limitations of each inspection technique still
have become apparent. This reality, coupled with the
increased use of flexible and semirigid plastic packaging
for acid and low-acid foods, made it necessary for the
FDA to continue to investigate the integrity of plastic
packages.
In the United States, the National Center for Food
Safety and Technology (NCFST) in affiliation with the
FDA has evaluated and reported several state-of-the-art
techniques; these include pressure differentials, magnetic
resonance imaging, ultrasonic immersion and airborne
imaging, high-voltage leak detection, and thermal ima-
ging techniques. However, there is still not sufficient
information available on capabilities and limitations of
the emerging techniques, in detecting various package
defects and tampering, over traditional visual and de-
structive offline inspection methods. It is because valida-
tion of each technique is container-specific, and the
detection sensitivity and online applicability of a techni-
que depend upon targeting defect types, container
shapes, and packaging materials. These evaluation stu-
dies should continue and will ultimately result in enhan-
cing efficiency in removing different types of defective
packages, reducing the risk of product recalls and sub-
sequent outbreaks, and improving the overall safety of
the food supply.
CONCLUSIONS
In summary, FDA’s major concern regarding container
integrity centers on the postprocess contamination of
acidified
and low-acid canned
foods. Requirements on all
metal double-seamed cans are clearly stated in Codes of
Federal Regulations, but the regulations for heat-sealed
flexible and semirigid plastic packages are not clearly
specified. It generally means that integrity tests for
flexible and semirigid containers developed by industry,
in the case of pouches, are reviewed by FDA, USDA, and/
or the army for applicability and soundness. If acceptable,
the tests are expected to be used. For many years, the
emphasis on container integrity had been on rigid contain-
ers such as double-seamed metal cans because the con-
tainer integrity issue started with processing of the metal
cans, and metal cans are still the dominant container in
the United States. However, FDA and USDA are just as
concerned with the integrity of hermetically sealed, non-
metal containers and are monitoring them as closely as
metal ones.
332 CONTAINER INTEGRITY REGULATION, USA