Food Packaging and Shelf Life 16 (2018) 225–231

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Food Packaging and Shelf Life

journal homepage: www.elsevier.com/locate/fpsl

Leakage analysis of flexible packaging: Establishment of a correlation T

between mass extraction leakage test and microbial ingress
⁎
Nastaran Moghimia, Hemi Sagib, Su-il Parka,
a
Department of Packaging, Yonsei University, Wonju, Gangwon-do, 26493, Republic of Korea
b
ATC, Inc., Indianapolis, IN, 46268, USA

A R T I C L E I N F O A B S T R A C T

Keywords: Package integrity over the shelf life of a product is critical in order to demonstrate the ability to maintain product
Microchannel defects sterility. The development of a rational physical test method to evaluate the microbial barrier properties of
Mass extraction sterile packages has necessitated its correlation to microbiological exclusion. In this study, the ability of a mass
Package integrity extraction leak detector to assess the integrity of multilayer pouches with a perforated microchannel was in-
Shelf-life
vestigated as an alternative to the microbial challenge test. Results were obtained for defects of four different
Food safety
sizes (15 to100 μm, with 5 mm channel lengths within the sealing component). The results of the tests indicated
that the leak tester possessed the ability to detect microchannel defects in sealed packages. Moreover, the mass
extraction system was able to reliably distinguish between intact samples and samples with the aforementioned
defects. The results of this study could be used to develop a time saving alternative method to analyze the sealing
quality of flexible packages.

1. Introduction microbial failure and physical measurements (Morrical et al., 2007;

Package integrity is a critical quality attribute for packaging of
sterile products as it is important for the protection of both the en-
vironment and the product itself. Pouch sterility must be maintained to
avoid product contamination; hence, any defects to the sterile condition
are considered to be a serious risk and often result in the disposal of
valuable products. In other words, it is important to maintain the shelf
life of a product until it reaches the consumer. Multilayer flexible
pouches have replaced some forms of heavy packaging such as glass
and cans. All types of flexible packaging provide a seal to close the
package. Typically, the sealing areas in flexible packaging are bonded
together by the application of heat. Therefore, these areas are where
most leaks would be expected to occur. A wrinkle in a sealing area can
form a channel leak because the leak length is significantly larger than
the diameter. However, sealing must be maintained to ensure product
sterility.
The microbial barrier properties of sterile product packaging are
typically determined through package integrity testing. This test
method can be accomplished by challenging packages with micro-
organism exposure. However, FDA guidelines encourage the industry to
develop package integrity and physical test methods in lieu of microbial
testing (FDA, 2004, 2008). The use of physical methods to test package
integrity depends on the establishment of a correlation between
Pethe and Dove, 2011; Singer, 2014).
Physical leak detection methods do not directly measure microbial
ingress; rather, they measure some physical property of the leak that
can be attributed to microbial failure. Additionally, validation studies
supporting the microbial integrity of packages are required. Current
physical technologies in the packaging industry are capable of detecting
leak rates, which is equivalent to detecting the size of defects. Thus, the
industry needs a method to test the integrity of flexible packaging that
can detect defects corresponding to the minimum size needed to block
waterborne microbes (FDA, 2004, 2008).
One of the major questions associated with package integrity and
physical testing development is the detection limits (or sensitivity) that
should be achieved by the method. Extensive studies have focused on
determining the smallest defect sizes allowing for microbial penetration
into packages, which have been shown to be as wide as 0.2–80 μm.
Lampi (1980) established and Chen, Harte, Lai, Pestka, and Henyon
(1991) and Keller et al. (1996) independently substantiated that the
critical dimension for defects, allowing bacterial penetration into flex-
ible pouches, was 11 μm or less, while Gilchrist, Shah, Radle, and
Dickerson (1989) determined that the critical dimension was twice that
(i.e., 22 μm). Blakiston et al. (1996) later established that the critical
size for leaks was 7 μm. Furthermore, other physical test methods have
demonstrated varying results for different defect shapes. Therefore, it is

⁎
Corresponding author.
E-mail address: parks@yonsei.ac.kr (S.-i. Park).

https://doi.org/10.1016/j.fpsl.2018.02.004
Received 14 June 2017; Received in revised form 26 January 2018; Accepted 14 February 2018
Available online 07 March 2018
2214-2894/ © 2018 Elsevier Ltd. All rights reserved.
N. Moghimi et al.
Fig. 1. Diagram of the mass extraction apparatus.
important that defects be defined when demonstrating the capabilities
of a method (Yoon, Sagi, Goldhammer, & Li, 2012). A defect can be
defined as an unintended crack, hole, or porosity in the walls of a
material or a sealing part (Lampi, 1980), which must contain or exclude
different fluids and gases while allowing the escape of a closed medium
(Pethe and Dove, 2011). If a packaging system contains defects, chan-
nels can be created in the packaging, and microorganisms can ingress
through the channels, affecting the safety of the product (Yoon et al.,
2012).
This study focused on investigating the mass extraction package
integrity test method and its application for testing the integrity of seals
in pouch type packaging in combination with previously reported
bioaerosol procedures (Moghimi, Kim, & Park, 2016). Therefore, mass
extraction, a mass flow measurement technology, was introduced as a
limit test; the detection limits were determined using the mass extrac-
tion measurement system. However, it was essential to determine the
accuracy of the system by which the equipment could perform tests in
order to develop confidence in its ability as an alternative to traditional
microbial methods.
The objective of this study was to determine the critical defect di-
mensions at which sterile channels form in pharmaceutical/food
packages. However, a bioaerosol challenge test has been used to de-
termine the critical size of leaks in the seals of LLDPE/nylon laminated
pouches. Furthermore, validation of the mass extraction-based proce-
dure was evaluated in relation to the microbial challenge method on a
significant scale. Therefore, an indirect correlation was established by
comparing the results of physical and microbial tests on samples con-
taining leaks of various sizes.
2. Materials and methods
2.1. Test pouches
The tests were performed on flexible laminated pouches with an
overall dimension of 170 mm × 100 mm (BNA Co., Korea). The pou-
ches were made from linear low-density polyethylene/nylon (LLDPE/
nylon), with a nominal filling volume of 150 mL, and total thickness of
113 μm with 15 μm of nylon layer.
2.2. Defect simulation and sample preparation
It was necessary to produce defects that were repeatable and con-
sistent to demonstrate the capabilities of the method when performing
tests to quantify microbial ingress into sterile packages (Kassarjian,
Bello, Bix, Burgess, & Linz, 2014). Channel leaks were intentionally
prepared using a technique according to the ASTM F1929 (2015) test
method. Only one leak was created by puncturing each pouch with a
tungsten wire ranging in size from 100, 50, 25, and 15 μm in diameter
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Food Packaging and Shelf Life 16 (2018) 225–231
(W558911, Oxford, England) across the sealing lip. Tungsten wire was
placed at a right angle to the sealing line, sealed with a sealer (ISA-350-
10, INNOSEAL, Korea) and then pulled through the seal after sealing.
The microchannel length for defects of all sizes was about 5 mm.
2.3. Microbiological challenge test
A total of 1200 pouches were subjected to the bioaerosol challenge
test. The testing unit and operating procedures to determine the critical
leak size for flexible packaging sterility using the bioaerosol challenge
test have been previously reported (Moghimi et al., 2016). Defective
test pouches were aseptically filled with 135 mL of a microbial growth
medium (Trypticase Soy Broth). Pouches attributed to the bioaerosol
chamber were developed by Keller (1998) with an internal volume of
0.13 m3 and were assembled with a nebulizer kit (Pari LC SPIRINT
0123, Germany) containing approximately 2.0 × 107 CFU m−3 of Sta-
phylococcus aureus (KCCM 11335) and Escherichia coli (DH 5α). A ne-
gative control was prepared to verify the sterility of the pouches and to
validate the aseptic filling process; a positive control was prepared to
verify the growth of the test microorganisms inoculated into the pou-
ches. For the positive control, a sample without defects was injected
with 0.2 mL of a 103 CFU/mL solution of organisms. The test pouches
were subsequently incubated at 37 °C. The growth medium inside the
test pouches was periodically checked for microbial growth over a
period of 14 days, indicating microbial ingress.
2.4. The mass extraction leak detector
A diagram of the mass extraction equipment system is shown in
Fig. 1. The leak tester was a VE2 mass extraction detector manufactured
by ATC Inc. (Advanced Test Concepts Inc., Indianapolis, IN, USA). A
test sample (shown in the diagram) was placed inside a test chamber
constructed of stainless steel. Yoon et al. (2012) described the equip-
ment and its operation to test the integrity of vials, syringes, and car-
tridges. In the current study, the method was modified to leak test
flexible pouch packages. In this flow regime, the micro-flow sensor
(Intelligent Gas Leak Sensor or IGLS) physical signal was proportional
to the volumetric flow rate. Therefore, the units in this study were
volumetric flow units or mm3/min. The mass extraction test possessed
four major steps to assess package integrity. The approximate testing
time required for each step should thus be determined.
1. Quick evacuation step: the chamber starts under barometric
conditions, and then most of the air surrounding the packaging is re-
moved (2–3 seconds is sufficient for flexible pouches). 2. Large leak
step: a quick initial check for any gross leaks. If there are gross leaks,
the sensor can detect the gross leak quickly via an excessive flow rate
and/or pressure increase, and the instrument will stop immediately. 3.
Evacuation step: the instrument performs a long evacuation step if there
N. Moghimi et al. Food Packaging and Shelf Life 16 (2018) 225–231

Fig. 2. Leak test signature. Intact and intact with a 5 micron glass (sharp edge) orifice attached to the chamber.

are no gross leaks in order to minimize any background noise due to
moisture in the air and the outgassing of packaging materials. An
evacuation period of 14 seconds was determined for the pouches. 4.
Measuring step (stability and test): the mass flow extracted from the
pouch increases continuously until reaching a steady state. For package
integrity testing, it is not necessary to obtain a steady state mass flow. It
was determined that 62, 77, 82, and 87 seconds were sufficient to
identify the difference between intact samples and samples containing
100, 50, 25, and 15 μm sized defects, respectively. An example of the
mass extraction test results is illustrated in Fig. 2.
2.5. Sample preparation for the mass extraction test
Defective and control pouches were filled with 135 mL ethanol and
were thermally sealed at 200 °C and 60 psi for 1 sec using a heat sealer
(ISA-350-10, INNOSEAL, Korea) after pressing out any air. The pouches
were tested for leaks immediately once each one filled. It was re-
commended to standardize the fill volume and avoid overpressurization
that can weaken the seal and create or increase the degree of leakage,
generating false results.
required to remove the airlock and break the liquid surface tension to
initiate fluid transport as follows:
4γ Cos θ
ΔP =
D (1)
where ΔP is the required pressure to overcome the airlock, γ is the
surface tension of the liquid, θ is the contact angle between surface
tension and the microchannel wall, and D is the flow path diameter (or
hydraulic diameter). If a pressure difference does not exist across the
defect, no flow can occur with regard to liquid leakage into the air. The
pressure required to break surface tension is independent of the flow
path length. However, if a lengthy microchannel is used, it can be
difficult to achieve the required pressure difference across the outlet of
the microchannel due to pressure losses from the inlet to outlet. An
overview of this and various other microchannel fluid transport me-
chanisms and the role of mass extraction leak testing in this field has
been summarized in papers authored by Gorti and Sagi (2006) and
Yoon et al. (2012).

2.7. Mass extraction test

2.6. Fluid transport through microgeometries theories
Testing with a mass extraction instrument, Model VE2, was auto-
Analytical fluid models require specific geometric dimensions with
mated. Evacuation of the test chamber and subsequent determination of
minimal entry and exit flow pressure losses. However, the micron-sized
the mass flow rate began when the pressure was below 44 kPa. A green
simulated defects cannot meet these requirements. Therefore, a perfect
lamp flashed if the leakage rate was below a preset limit. For results
model for each type of defect does not exist. Fluid models should be
above the limit, a red lamp flashed with an accompanying acoustic
used for a “magnitude of order” estimation and an analysis of the
signal. For most tests, a measuring time of 5 seconds (after an
parameters influencing material transport phenomena. Various fluid
11–14 seconds test chamber evacuation period) was sufficient. The
models have been previously reviewed (Fox, Pritchard, & Mcdonald,
absolute leak rates were determined with a mass extraction leak de-
2009; Gorti & Sagi, 2006; Karniadakis & Beskok, 2002).
tector. A comparison of the transmission component test signature with
The fluid models for micron-sized channels can be divided into
and without a leak is illustrated in Fig. 2.
models for compressible fluids (gases) and incompressible fluids (li-
Channel leaks were intentionally prepared as described in Section
quids). The behavior of fluid resistance to flow (or pressure loss)
2.2 of this paper. Packages without channel leaks were used as a con-
through a microgeometry (defect) with liquid on one side and air on the
trol. Sixty replicates for each leak size were prepared and analyzed
other can be expressed by the classical Young-Laplace equation (Eq.
using the mass extraction unit.
(1)). This equation can be used to estimate the total pressure difference

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Fig. 3. SEM images of a microchannel inlet diameter. (a) 100 μm, (b) 50 μm, (c) 25 μm, and (d) 15 μm.
Images adapted from Moghimi et al. (2016).

3. Results and discussion Table 1

Results of testing seals of defected pouches with microbial challenge testing.
3.1. Verification of defected samples
Defect size Number of Number of pouches Percent of identified
(μm) tested exhibiting microbial defected pouches (%)
Internal diameters were verified with a light microscope. The dia- pouchesc growth after 14 days after 14 days
meters of the microchannels could be maintained with a variation of
100 300 152 50
less than ± 0.5 μm. Fig. 3 presents scanning electron microscopic (SEM)
50 300 90 30
images of the outlet cross sections for microchannels that are 100, 50, 25 300 9 3
25, and 15 μm in size. 15 300 0 0
Negative 25 0 0
controla
3.2. Microbiological challenge test results
Positive 25 25 100
controlb
The detection of microbial ingress depends on the probability that
the challenge organism can find a package leak, the ability of the or- a,b
None of the negative controls or positive controls contained defects.
c
ganism to move through the microchannel, and its ability to grow in the Total number of pouches tested during the study for each microchannel size.
internal package environment. As expected, microbial ingress into a
package took more time as the defect size decreased. The results ob- static head pressures. As the defect size decreases, the threshold pres-
tained for 300 repetitions for each defect size are summarized in sure for a given liquid increases. Thus, in test pouches with 15 μm sized
Table 1. As seen in the table, pouches with a 15 μm microchannel did defects, the threshold pressure was lower than the liquid surface tension
not exhibit any contamination, indicating that the microbes could not force, preventing the ingress of liquid into the air-filled channel and
ingress via a microchannel of this size. eliminating the growth media for the microbes. Based on these results,
To initiate microbial ingress through a defect, the pressure inside it was clear that defects larger than 15 μm could result in a breach in
the test pouch (i.e., threshold pressure) must overcome the liquid sur- sterility. Therefore, integrity testing for online package testing must be
face tension forces and cause liquid to flow through the defect, thus able to detect 15 μm sized defects to ensure product sterility.
providing a channel for microbes to travel into the pouch. The mag- The results of this test indicated with a high level of confidence that
nitude of the threshold pressure required to initiate liquid flow depends flexible laminated LLDPE/nylon pouches with 15 μm microchannels
on the properties of the liquid, hydrophobic/hydrophilic interactions that were 5 mm in length would be expected to maintain the sterility of
between the film material and the liquid, defect diameter, and the their contents after exposure to microbiologically challenging condi-
pressure gradient between the inside and outside of the pouch. The tions.
pressure also depends on the location of the defect due to differences in

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Fig. 4. An example of the test profile between the intact sample and samples with 15, 25, 50, and 100 μm sized defects.
3.3. Mass extraction detection in flexible pouch packages
The correlation between defect size and leak flow rate is shown in
Fig. 4. All samples except the 15 μm sized defect sample and the intact
sample reached 1140 mm3/min, which was the full measurement range
of the unit. It was observed that larger defects reached 1140 mm3/min
faster. This correlation could be used to identify defects larger than
15 μm in size. The focus of the sequel was to discuss the influence of
sealing/closing parameters and on studies where a risk of leakage was
expected and/or leaky test items were involved. Perceptibly, mass flow
increased as microchannel size increased.
The leak sensitivity of the mass extraction leak detector for these
leaks is shown in Fig. 5. This figure shows percentages of the different
leak sizes detected by the equipment, as well as a comparison of the
results of this test and results of the bioaerosol challenge test. For
channel leaks measuring 100, 50, and 25 μm in size, all leaking samples
were detected by the mass extraction leak test (100%). Additionally,
channel leaks measuring 15 μm in size were also detected (97% of the
Fig. 5. Percent leak sizes detected within flexible pouch packaging by the mass extraction leak detector and bioaerosol challenge leak test.
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Food Packaging and Shelf Life 16 (2018) 225–231
population). After leak measurement, non-detected pouches with 15 μm
microchannels were squeezed by hand to check for blockages; small
drips formed on the surface of the channel showing that they were not
blocked. As mentioned previously, long microchannels with small dia-
meters had a higher probability of being plugged with contaminants,
which could explain the reduction. The results describe the likelihood
of a package with a given leak size to be detected as defective by the
mass extraction instrument for microchannel type defects larger than
15 μm in size, where the rejection limits were set to any measurement
above 400 mm3/min for this process. Moreover, all leaks (even the
smallest < 15 μm) could be detected with VE2. However, the instru-
ment has been configured to ensure microbial safety based on the re-
sults of the microbial challenge test. Hence, any leaking pouches were
automatically detected by the sensor within 80 seconds.
The sensitivity of the detector to leaks, especially smaller sized
leaks, was directly related to its ability to force the contents of the
package through the microchannel created in its seals. In this mass
extraction system, the minimum force required to cause the contents of
N. Moghimi et al.
a test package to escape through a leak could be determined by Hagen-
Poiseuille’s equation. According to the steady (laminar) flow of a liquid
through a given leak, the volume of liquid inside a package that will
flow through a leak will depend on the viscosity of the liquid, the radius
of the leak, and the pressure gradient along the leak. This pressure
gradient will be the quotient of the pressure difference between the
inside and outside of the package divided by the length of the leak. For
low Reynold number flows, this can be expressed through the following
equation:
πr 4ΔP
Q=
8ηL
where Q is the volumetric flow rate (m3/s), r is the radius of the channel
(m), ΔP is the pressure differential (Pa), L is the length of the channel
(leak) (m), and η is the dynamic fluid viscosity (N s m2) of the fluid
(liquid within the package). Eq. (2) is primarily applicable to non-
compressible fluids (liquids). For the flow of a liquid to proceed from
the inside to the outside of a package, the pressure difference must be
positive. In other words, pressure must be greater on the inside of the
package. However, correlations based on this model for compressible
fluids are limited to a narrow, low differential pressure range. More-
over, this model is based on no-slip conditions, which are not applicable
when dealing with channels that are a few microns in size. Poiseuille’s
equation can describe the volume of fluid that is lost from a package at
any given time. This shows that identifying leaks with smaller radius is
more cumbersome due to the small volume of fluid flowing through
such leaks.
Poiseuille’s equation can describe the volume of fluid that is lost
from a package at any given time. This shows that identifying leaks
with smaller radius is more cumbersome due to the small volume of
fluid flowing through such leaks. Note that the surface tension of water
is 72.8 mN/m at 20 °C and the contact angle is near zero (Fox et al.,
2009). Total pressure differentials of 2.91 kPa, 5.82 kPa, and 19.4 kPa
are required to remove the air lock for 100, 50, and 25 μm diameter
defects, respectively.
3.4. Correlation of the bioaerosol challenge test results with mass extraction
leakage rates
The VE2 results have already met the safe package inspection re-
quirements in terms of critical channel size for package integrity. In
other words, the system can reliably detect channel defects for dia-
meters as small as 15 μm. Fig. 5 shows a comparison of the mass ex-
traction method and bioaerosol challenge test in terms of the prob-
ability to detect defective pouches. There was a clear difference
between intact pouches and pouches with defects.
The microbial challenge test that was selected in this study was in
excess of the environmental conditions by which a product packed
within a flexible pouch would be exposed. The employed method was
much closer to the real world stress that a package might experience
during its life-cycle than the other available microbial tests (e.g., im-
mersion microbial test). Therefore, the results of the bioaerosol test
already showed that a 15 μm microchannel was critical to ensuring
product safety; the mass extraction equipment settings were configured
to detect all samples that included a 15 μm defect.
Microbial failure could occur at a leak rate of 1140 mm3/min,
roughly corresponding to a leak diameter ≥25 μm in size. However, the
critical leak rate, the value below which microbial ingress could not
occur, was observed to be 468 mm3/min, corresponding to a defect
diameter of 15 μm in this study (Fig. 4). These mass flow acceptance
criteria could be used to ensure the package integrity of pouches based
on detection limits equivalent to a single microchannel greater than
15 μm in size.
In order to extend the detection limits, the measurement duration
would need to be prolonged. However, enhancing the sensitivity of
Food Packaging and Shelf Life 16 (2018) 225–231
equipment has great importance to the device industry. As device
packagers consider the alternatives [i.e., emerging integrity tests], a
sufficient sensitivity must be determined. A test that overlooks defects,
thus allowing microbial penetration, could have a negative impact on
human health. However, a test that fails packages that do not pose a
health risk can increases costs needlessly. Therefore, it is important to
determine the minimum defect size that will allow microbial penetra-
tion into packages.
4. Conclusions
(2) In this study, a mass extraction leak detector was set to detect de-
fects from 15 μm in size after testing packages with a microbial test. A
correlation between the bioaerosol challenge test and the mass ex-
traction test was used to identify the critical absolute mass extraction
that was an indicator to a lack of microbial ingress. Examples showed
the advantages of the mass extraction leak test in the selection of a
flexible container system and the optimization of closing parameters,
thus ensuring food and pharmaceutical product quality and stability.
The studies performed also demonstrated the versatility of the mass
extraction leak test with a test chamber for flexible pouch products.
The VE2 leak instrument was capable of detecting all defects created
in flexible pouch packages through a non-destructive, fast, and re-
producible test. In the mass extraction test method, the test parameters
or measurement units were assumed to be of secondary importance to
the method of leak testing (microflow, tracer gas, pressure decay, etc.)
as each leak test was based on a comparison with the equivalent mi-
crochannel (geometry) leak performance under those test conditions.
Acknowledgments
The authors wish to thank Dr. Seung-Yil Yoon and Ellice Son for
their technical support and guidance and the equipment supplier ATC
for technical support.
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