U.S. patent application number 13/029003 was filed with the patent office on 2012-08-16 for medical device package vacuum sealer and burst tester.
This patent application is currently assigned to Van der Stahl Scientific, Inc.. Invention is credited to Charlie Webb.
Application Number | 20120204521 13/029003 |
Document ID | / |
Family ID | 46635813 |
Filed Date | 2012-08-16 |
United States Patent
Application |
20120204521 |
Kind Code |
A1 |
Webb; Charlie |
August 16, 2012 |
MEDICAL DEVICE PACKAGE VACUUM SEALER AND BURST TESTER
Abstract
One example embodiment includes a system for sealing and burst
testing a medical device package. The system includes a nozzle,
where the nozzle is configured to be inserted into a medical device
package. The system also includes an air pump, where the air pump
is configured to remove air from the medical device package through
the nozzle and insert air into the medical device package through
the nozzle for burst testing. The system further includes a sealer,
where the sealer is configured to seal the medical device
package.
Inventors: |
Webb; Charlie; (Idyllwild,
CA) |
Assignee: |
Van der Stahl Scientific,
Inc.
Idyllwild
CA
|
Family ID: |
46635813 |
Appl. No.: |
13/029003 |
Filed: |
February 16, 2011 |
Current U.S.
Class: |
53/507 ;
53/79 |
Current CPC
Class: |
B29C 66/43121 20130101;
B29C 65/18 20130101; B29C 66/91431 20130101; B29C 66/0044 20130101;
B29C 66/3452 20130101; B29C 66/91421 20130101; B29C 65/8246
20130101; B29L 2031/7128 20130101; B29C 66/53262 20130101; B29C
66/1122 20130101; B29C 65/38 20130101; B65B 31/06 20130101; B29L
2031/7148 20130101; G01N 3/12 20130101 |
Class at
Publication: |
53/507 ;
53/79 |
International
Class: |
B65B 31/06 20060101
B65B031/06; B65B 57/00 20060101 B65B057/00 |
Claims
1. A system for sealing and burst testing a medical device package,
the system comprising: a nozzle, wherein the nozzle is configured
to be inserted into a medical device package; an air pump, wherein
the air pump is configured to: remove air from the medical device
package through the nozzle; and insert air into the medical device
package through the nozzle for burst testing; and a sealer, wherein
the sealer is configured to seal the medical device package.
2. The system of claim 1 further comprising a sensor, wherein the
sensor is configured to measure the air pressure within the medical
device package.
3. The system of claim 2, wherein the sensor instructs the sealer
to seal the medical device package when the air pressure goes below
a threshold pressure.
4. The system of claim 2, wherein the sensor is configured to
measure the air pressure at which the medical device package
bursts.
5. The system of claim 1, wherein the nozzle is configured to be
retracted from the medical device package prior to the sealer
sealing at least a portion of the medical device package.
6. The system of claim 1, wherein the air pump is further
configured to reverse the direction of air flow.
7. The system of claim 1, wherein the air pump is configured to
insert air into the medical device package until the medical device
package bursts.
8. The system of claim 1, wherein the sealer is configured to melt
at least a portion of the medical device package.
9. The system of claim 1 further comprising an insertion device,
wherein the insertion device is configured to insert the nozzle
into the unsealed medical device package.
10. The system of claim 9, wherein the insertion device is
configured to insert the nozzle into the sealed medical device
package.
11. A system for sealing and burst testing a medical device
package, the system comprising: a nozzle, wherein the nozzle is
configured to be inserted into a medical device package, an air
pump, wherein the air pump is configured to: remove air from the
medical device package through the nozzle; and insert air into the
medical device package through the nozzle; a sealer, wherein the
sealer is configured to seal the medical device package; and a
logic device, wherein the logic device is configured to control the
operation to of the air pump and the sealer.
12. The system of claim 11, wherein the logic device includes a
processor.
13. The system of claim 11, wherein the logic device instructs the
air pump to remove air from the medical device package during a
sealing operation.
14. The system of claim 13, wherein the air pump continues to
remove air from the medical device package until the air pressure
drops below a predetermined threshold.
15. The system of claim 11, wherein the logic device is configured
to notify an operator if the air pressure fails to drop below the
predetermined threshold after a certain period of time.
16. A system for sealing and burst testing a medical device
package, the system comprising: a system housing; a sealer
supported by the system housing, the sealer forming a seal on a
medical device package by localized heating to a temperature that
melts at least a portion of the medical device package; a nozzle
supported by the system housing, wherein the nozzle is configured
to be inserted into the medical device package, an air pump
supported by the system housing, wherein the air pump is configured
to: remove air from the medical device package through the nozzle;
and insert air into the medical device package through the nozzle;
and a logic device supported by the system housing and coordinating
with both the sealer and the air pump; wherein, during a sealing
operation, the logic device instructs the air pump to remove air
from the medical device package; wherein, during a burst testing
operation, the logic device instructs the air pump to reverse air
flow and insert air into the medical device package; wherein the
logic device measures the maximum air pressure which is attained
within the medical device package during the burst testing
operation; and wherein the logic device compares the maximum air
pressure to a predetermined threshold.
17. The system of claim 16, wherein the logic device stops
operation and notifies an operator if the maximum air pressure is
below the predetermined threshold.
18. The system of claim 16, wherein the logic device is configured
to perform a burst testing operation after the system has performed
a predetermined number of sealing operations without a burst
testing operation.
19. The system of claim 16 further comprising a memory, wherein the
memory is configured to record the results of prior burst testing
operations.
20. The system of claim 16 further comprising an output port,
wherein the output port is configured to transmit the result of the
comparison by the logic device of the maximum air pressure to the
predetermined threshold.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Not applicable.
BACKGROUND OF THE INVENTION
[0002] Packages sealed by medical sealers must meet government
standards; therefore, the seal integrity of packages must be
routinely tested during production to assure there will be no loss
of device sterility. There are different tests for evaluating seal
strength and integrity, the most common being peel testing, burst
testing and visual testing. Peel testing is a common way to
determine seal strength utilizing destructive methodology. Burst
testing is another common test methodology for whole pouch testing
to understand package limits by sacrificing pouch through air
inflation to the point of burst.
[0003] These test modalities are used when developing the
preliminary Design of Experiments for the validation processes, as
well as for routine testing for the process of quality assurance.
The visual process is used most often as an in-process system of
seal inspection as it is non-destructive. Peel testing measures the
strength of seal in pounds, or newtons, while visual testing
analyzes seal integrity for anomalies such as pleating, cracking,
bubbling, etc. Burst testing provides feedback as to the total
package value, as seals and material are pushed to discover the
weakest point of the pouch.
[0004] However, basic medical pouch sealers used in the art today
do not include a mechanism for thorough evaluation of whole package
total strength. Currently, when a medical packager seals a pouch
using a medical sealer, he or she must occasionally pull a pouch
out of production to test the seal. Testing the seal usually
involve taking the pouch to a lab where the material is cut into a
one-inch strip and pulling the material apart using, for example,
an industrial ASTM F-88 seal strength test to determine the
integrity of the seal. This can lead to a lag time in discovering
problems in medical device package integrity. In particular,
problems may not become apparent for some time which means more
medical devices that have to be repackaged and a loss of production
time.
[0005] Accordingly, there is a need in the art for a system that is
capable of completing medical device package testing for the whole
medical device package. Additionally, there is a need in the art
for the system to test the medical device package at the site of
sealing. Further, there is a need in the art for the system to
discover problems quickly.
BRIEF SUMMARY OF SOME EXAMPLE EMBODIMENTS
[0006] This Summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the Detailed Description. This Summary is not intended to identify
key features or essential characteristics of the claimed subject
matter, nor is it intended to be used as an aid in determining the
scope of the claimed subject matter.
[0007] One example embodiment includes a system for sealing and
burst testing a medical device package. The system includes a
nozzle, where the nozzle is configured to be inserted into a
medical device package. The system also includes an air pump, where
the air pump is configured to remove air from the medical device
package through the nozzle and insert air into the medical device
package through the nozzle for burst testing. The system further
includes a sealer, where the sealer is configured to seal the
medical device package.
[0008] Another example embodiment includes a system for sealing and
burst testing a medical device package. The system includes a
nozzle, where the nozzle is configured to be inserted into a
medical device package. The system also includes an air pump, where
the air pump is configured to remove air from the medical device
package through the nozzle and insert air into the medical device
package through the nozzle. The system further includes a sealer,
where the sealer is configured to seal the medical device package,
and a logic device, where the logic device is configured to control
the operation to of the air pump and the sealer.
[0009] Another example embodiment includes a system for sealing and
burst testing a medical device package. The system includes a
system housing and a sealer supported by the system housing, the
sealer forming a seal on a medical device package by localized
heating to a temperature that melts at least a portion of the
medical device package. The system includes a nozzle supported by
the system housing, where the nozzle is configured to be inserted
into the medical device package, and an air pump supported by the
system housing. The air pump is configured to remove air from the
medical device package through the nozzle and insert air into the
medical device package through the nozzle. The system also includes
a logic device supported by the system housing and coordinating
with both the sealer and the air pump. During a sealing operation,
the logic device instructs the air pump to remove air from the
medical device package. During a burst testing operation, the logic
device instructs the air pump to reverse air flow and insert air
into the medical device package. The logic device measures the
maximum air pressure which is attained within the medical device
package during the burst testing operation and compares the maximum
air pressure to a predetermined threshold.
[0010] These and other objects and features of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] To further clarify various aspects of some example
embodiments of the present invention, a more particular description
of the invention will be rendered by reference to specific
embodiments thereof which are illustrated in the appended drawings.
It is appreciated that these drawings depict only illustrated
embodiments of the invention and are therefore not to be considered
limiting of its scope. The invention will be described and
explained with additional specificity and detail through the use of
the accompanying drawings in which:
[0012] FIG. 1 illustrates an example of a system for sealing a
medical device package;
[0013] FIG. 2 illustrates a block diagram of the components of the
system for sealing a medical device package;
[0014] FIG. 3 illustrates an example of a medical device package in
the process of being sealed;
[0015] FIG. 4 illustrates an example of a medical device package in
the process of being tested; and
[0016] FIG. 5 is a flow chart illustrating a method of sealing and
testing a medical device package.
DETAILED DESCRIPTION OF SOME EXAMPLE EMBODIMENTS
[0017] Reference will now be made to the figures wherein like
structures will be provided with like reference designations. It is
understood that the figures are diagrammatic and schematic
representations of some embodiments of the invention, and are not
limiting of the present invention, nor are they necessarily drawn
to scale.
[0018] FIG. 1 illustrates an example of a system 100 for sealing a
medical device package. In at least one implementation, the system
100 can be used to seal a medical device package such that the
medical device remains sterile until needed in a medical procedure.
In particular, the sterilized medical device can be vacuum sealed
in a medical device package such that the medical device cannot
come in contact with outside contaminates, such as air, bacteria,
biological fluids or other contaminates.
[0019] FIG. 1 shows that the system 100 can include a housing 105.
In at least one implementation, the housing 105 is configured to
surround the other elements of the system 100. For example, the
housing 105 can ensure that electrical elements are properly
insulated from one another and from outside electrical signals or
from other debris such as dust. Additionally or alternatively, the
housing 105 can serve to ensure that the other elements of the
system 100 are oriented correctly relative to one another. One of
skill in the art will appreciate that the housing 105 can cover all
of the other components of the system 100 or only a portion thereof
and that the housing 105 need not be exterior to the other
components of the system 100.
[0020] FIG. 1 also shows that the system 100 can include a sealer
110. In at least one implementation, the sealer 110 is configured
to seal the medical device package. In particular, the sealer 110
can melt a portion of the medical device package to provide a seal
that is air tight and water resistant. As used in the specification
and the claims the term air tight shall mean that the seal does not
allow air to pass through the seal. I.e., the seal allows the
medical device package to maintain vacuum pressure, or other
non-ambient air pressure within the medical device package.
[0021] FIG. 1 shows that the sealer 110 can include a jaw mechanism
115. In at least one implementation, the jaw mechanism 115 can
include an upper jaw and a lower jaw. A solenoid, pneumatic piston
or other device can engage the jaw mechanism 115 to pull the upper
jaw down onto the lower jaw, or vice versa, in order to apply the
necessary pressure to the flexible package or pouch. The pressure
exerted by the jaw mechanism 115 can be controlled by a control
knob, controlled electronically or controlled in some other manner
to ensure that the pressure is consistent.
[0022] In at least one implementation, the sealer 110 can also
include a heating element. The heating element can flash heat to a
predetermined temperature to melt at least a portion of the
packaging material. The heating element can maintain the
temperature for a specific time to create a bond among the two
sides of the medical device package. Pieces of Teflon, Sarcon, and
glass cloth can be disposed on either side of the jaw mechanism 115
to prevent the medical device packaging materials from sticking to
the jaw mechanism 115.
[0023] FIG. 1 further shows that the system 100 can include a
nozzle 120. In at least one implementation, the nozzle 120 is
configured to be inserted into a medical device package. The nozzle
120 can then be used to remove air from the medical device package
or insert air into the medical device package, as described below.
In particular, the medical device package can be substantially
sealed then the nozzle 120 can be inserted into the unsealed
portion of the medical device package. The air can then be removed
during a sealing operation or inserted during a burst testing
operation, as described below.
[0024] FIG. 1 also shows that the system 100 can include a data
port 125. In at least one implementation, the data port 125 can be
used to transmit data between the system 100 and an external
system. For example, the data port 125 can be used to transmit
burst testing results. Additionally or alternatively, the data port
125 can be used to receive software updates or to change settings
of the system 100.
[0025] FIG. 1 further shows that the system 100 can include a
display 130. In at least one implementation, the display 130 can
provide status updates to a user. For example, the display 130 can
display the results of recent burst testing operations.
Additionally or alternatively, the display 130 can be used to
change settings of the system 100. For example, the display 130 can
include a touch screen display that is allows a user to look up and
modify settings of the system 100.
[0026] FIG. 2 illustrates a block diagram of the components of the
system 100 for sealing a medical device package. In at least one
implementation, the components of the system 100 can be used to
seal a medical device package, as described above. One of skill in
the art will appreciate that the components can be combined,
separated or connected in alternative schemes without restriction,
unless otherwise stated in the specification or the claims.
[0027] FIG. 2 shows that the system 100 can include a logic device
205. In at least one implementation, a logic device 205 can include
any device capable of performing logic functions. For example, the
logic device 205 can perform Boolean logic or can produce a
pre-determined output based on input. The logic device 205 can
include ROM memory, programmable logic device (PLD), programmable
array logic (PAL), generic array logic (GAL), complex programmable
logic device (CPLD), field programmable gate arrays (FPGA), logic
gates, processors or any other device capable of performing logic
functions.
[0028] In at least one implementation, the logic device 205 can
control the functions of the other components of the system 100. In
particular, the logic device 205 can ensure that the components of
the system 100 perform their desired function at the appropriate
time and in the appropriate manner. The timing of functions can be
critical to ensure that the medical device package is sealed
properly to keep the medical device stored in a sanitary
condition.
[0029] FIG. 2 shows that the logic device 205 is connected to the
sealer 110. In at least one implementation, the sealer 110 is
configured to seal the medical device packaging, as described
above. For example, the medical device packaging can be partially
or completely sealed prior to insertion of the medical device. The
sealer 110 can then be used to complete the seal of the medical
device packaging after the medical device has been inserted.
[0030] In at least one implementation, the logic device 205 can
control the operation of the sealer 110. In particular, after the
air is removed from the medical device package, the logic device
205 can control the jaw mechanism 115 to hold the medical device
package closed. The logic device 205 can then turn on the heating
element 210 to complete the seal. After the seal has set, the logic
device 205 can open the jaw mechanism 115 to release the medical
device package. The logic device 205 can use a sensor to determine
when to move from one step to the next or can time each step to
occur at the appropriate time.
[0031] FIG. 2 also shows that the system 100 can include a nozzle
insertion device 215. In at least one implementation, the nozzle
insertion device 215 can move the nozzle 120 into and out of the
medical device package. One of skill in the art will appreciate
that the nozzle 120 insertion or removal can be accomplished by
moving the nozzle or the medical device package or in any other
manner. For example, the nozzle 120 can be moved while the medical
device package is held stationary by the jaw mechanism 115.
Alternatively, the jaw mechanism 110 or an operator can move the
medical device package onto the nozzle 120.
[0032] FIG. 2 shows that the logic device 205 can be connected to
the nozzle insertion device 215. In at least one implementation,
the logic device 205 can control the insertion or removal of the
nozzle 120 into or out of the medical device package respectively.
For example, when the medical device package is in place, the logic
device 205 can move the nozzle 120 using the nozzle insertion
device 215 such that a portion of the nozzle 120 is within the
medical device package and capable of allowing air to be removed
from the medical device package, as described below. Alternatively,
when the air has been removed from the medical device package, the
logic device 205 can instruct the nozzle insertion device 215 to
remove the nozzle 120 from the medical device package so that the
sealer 110 can seal the medical device package.
[0033] FIG. 2 further shows that the system 100 can include an air
pump 220. In at least one implementation, the air pump 220 can be
connected to the nozzle 120 for removing air from the medical
device packaging. For example, the air pump 220 can remove air from
the medical device package before the medical device package is
sealed. Additionally or alternatively, the air pump 220 can insert
air into the medical device package in order to determine if the
seal meets the required safety standards.
[0034] In at least one implementation, the logic device 205 can be
capable of controlling the air pump 220. In particular, the logic
device 205 can pump air from the medical device package during a
sealing operation. Alternatively, the logic device 205 can reverse
the air flow through the nozzle 120 such that the air pump 220 is
inserting air into the medical device package during a burst
testing operation.
[0035] FIG. 2 shows that the air pump 220 can include an air
pressure sensor 225. In at least one implementation, the air
pressure sensor 225 can measure the air pressure within the medical
device package. For example, if the air pump 220 is removing air
form the medical device package during a sealing operation the air
pressure sensor 225 can determine when an acceptable amount of air
has been removed. Additionally or alternatively, the air pressure
sensor 225 can determine the maximum air pressure attained within
the medical device package before the package bursts during a
testing operation.
[0036] In at least one implementation, the logic device 205 can
compare the maximum air pressure attained within the medical device
package to determine if the seal conforms to the required
standards. For example, the air pressure required to burst the
package can be compared to the ASTM F1140 requirements for Internal
Pressurization Failure Resistance of Unrestrained Packages and or
the ISO 11607 standard for packaging for terminally sterilized
medical devices which references are incorporated herein by
reference in their entirety. If the maximum air pressure indicates
that the seal was inadequate, the logic device 205 can stop
operation of the system 100 and alert a user so that the user can
determine if the seals are being created adequately or if changes
or repairs need to be made.
[0037] FIG. 2 further shows that the system 100 can include a
memory 230. In at least one implementation, the memory 230 can
include any device capable of storing data in computer readable
form. The memory 230 can include volatile memory and non-volatile
memory. Volatile memory can include dynamic random access memory
(DRAM), static random access memory (SRAM), thyristor random access
memory (T-RAM), zero capacitor random access memory (Z-RAM), twin
transistor random access memory (TTRAM), delay line memory,
selectron tube and williams tube. Non-volatile memory can include
read-only memory (ROM), programmable read only memory (PROM),
erasable programmable read only memory (EPROM), electrically
erasable programmable read only memory (EEPROM), flash memory,
ferroelectric random access memory (FeRAM), magnetoresistive random
access memory (MRAM), phase change random access memory (PRAM, aka
PCM, PRAM, PCRAM, ovonic unified Memory, chalcogenide random access
memory and C-RAM), conductive-bridging random access memory (CBRAM
aka. programmable metallization cell or PMC),
silicon-oxide-nitride-oxide-silicon (SONOS), resistive
random-access memory (RRAM), racetrack memory, nano random access
memory (NRAM), millipede, drum memory, magnetic core memory, plated
wire memory, bubble memory and twistor memory.
[0038] In at least one implementation, the memory 230 can be used
to store results of the comparisons done by the logic device 205.
I.e., the memory 230 can store the results of recent tests to be
accessed as desired by a user. Additionally or alternatively, the
memory 230 can store the required standards, against which the
measured air pressure will be compared by the logic device 205.
[0039] FIG. 3 illustrates an example of a medical device package
305 in the process of being sealed. In at least one implementation,
the medical device package 305 is configured to allow a medical
device 310 to be stored in a sterile environment. In particular,
the sterilized medical device 310 can be vacuum sealed in the
medical device package 305 such that the medical device 310 cannot
come in contact with outside contaminates, such as air, bacteria,
biological fluids or other contaminates.
[0040] FIG. 3 shows that the medical device package 305 can include
presealed portions 315. In at least one implementation, the
presealed portions 315 can be sealed prior to the insertion of the
medical device 310 into the medical device package 305.
Additionally or alternatively, the presealed portions 315 can be
sealed after the medical device 310 has been inserted into the
medical device package 305.
[0041] FIG. 3 also shows that the medical device package 305 can be
placed with the nozzle 120 within the medical device package 305.
In particular, the nozzle 120 can be placed within the medical
device package 305 to remove the air from the medical device
package 305 during a sealing operation. The nozzle 120 can be flat
or substantially flat in order to allow the medical device package
305 to be sealed, as described above.
[0042] FIG. 3 further shows that the jaw mechanism 115 can be
closed around a portion of the medical device package 305. In at
least one implementation, the jaw mechanism 115 can hold the
unsealed portion of the medical device package 305 during air
removal and sealing. This can allow the air within the medical
device package 305 to be removed through the nozzle 120. I.e., the
nozzle 120 remains the only open area through which air can enter
or exit the medical device package 305. The unsealed portion of the
medical device package 305 can then be sealed using a heating
mechanism, as described above.
[0043] FIG. 4 illustrates an example of a medical device package
305 in the process of being tested. In at least one implementation,
the test determines the pressure at which any portion of the seals
in the medical device package 305 burst or fail. I.e., the pressure
at which any portion of the seals burst is determined and compared
against applicable standards to ensure that the seals are
sufficient to protect the medical device 310 against contaminates.
One of skill in the art will appreciate that the burst testing
operation can be completed immediately after the sealing operation.
That is, the same system can be used to seal the medical device
package 305 and test the seals.
[0044] FIG. 4 shows that the medical device package 305 can remain
with the nozzle 120 within the medical device package 305. In at
least one implementation, the nozzle 120 can remain within the
medical device package 305 to insert air into the medical device
package 305 during a burst testing operation. I.e., the nozzle 120
can be used to insert air into the medical device package 305,
until the medical device package 305 bursts and the maximum air
pressure attained can be measured and compared to the applicable
standards for a burst testing operation.
[0045] FIG. 4 further shows that the jaw mechanism 115 can be
opened during the testing operation. In at least one
implementation, the jaw mechanism 115 can be opened to ensure that
any resistance of the seals to bursting is not enhanced by the
closed jaw mechanism 115. I.e., the burst testing operation can be
performed with the jaw mechanism 115 open to ensure that the seals
alone are tested.
[0046] In at least one implementation, the air pressure can be
monitored during insertion of the air into the medical device
package 305. The maximum pressure attained can then be compared to
a minimum acceptable threshold. If the maximum pressure meets or
exceeds the minimum acceptable threshold, the seal is deemed to be
acceptable. If the maximum pressure is lower than the minimum
acceptable threshold, the seal is deemed unacceptable and the
operator is alerted to the failure.
[0047] FIG. 5 is a flow chart illustrating a method 500 of sealing
and testing a medical device package. In at least one
implementation, the medical device package can be tested to ensure
that it conforms to governmental regulations or other packaging
requirements. The testing can be done at regular intervals or when
there is need for immediate testing. One of skill in the art will
appreciate that the method 500 can be used with the system 100 of
FIG. 1; however, the method 500 can be used with a system other
than the system 100 of FIG. 1.
[0048] FIG. 5 shows that the method 500 can include sealing a
medical device package 505. In at least one implementation, the
medical device package can have the air removed before the sealing
operation. Removing the air can help thwart the possible decay of
imbedded drugs on the medical device by removing the ambient air
that would contact the medical device placed within the medical
device package. In particular, the lack of air can prevent unwanted
bursting or popping of the medical device package. Additionally or
alternatively, the lack of air can prevent pathogens from growing
within the medical device package.
[0049] FIG. 5 also shows that the method 500 can include inflating
the medical device package 510. In at least one implementation, the
medical device package can be inflated until it bursts. The medical
device package can be inflated using a nozzle left in place when
the medical device package is sealed. Additionally or
alternatively, a nozzle can be inserted into the medical device
package for the purpose of inflating the package.
[0050] FIG. 5 further shows that the method 500 can include
determining whether the burst pressure exceeds the maximum
allowable threshold 515. In at least one implementation, the air
pressure within the medical device package can be monitored while
air is being added to the medical device package with the burst
pressure indicating the maximum air pressure attained within the
medical device package.
[0051] FIG. 5 also shows that the method 500 can include deeming
the test successful if the burst pressure is equal to or exceeds
the maximum allowable threshold 520. In contrast, the method 500
can include deeming the test a failure if the burst pressure does
not exceed the maximum allowable threshold 525. In at least one
implementation, if the test is a failure, a user can be notified or
other corrective action can be taken to ensure that the medical
device packaging is being properly sealed.
[0052] One of skill in the art will appreciate that, for this and
other processes and methods disclosed herein, the functions
performed in the processes and methods may be implemented in
differing order. Furthermore, the outlined steps and operations are
only provided as examples, and some of the steps and operations may
be optional, combined into fewer steps and operations, or expanded
into additional steps and operations without detracting from the
essence of the disclosed embodiments.
[0053] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *