MEDICAL DEVICE PACKAGE VACUUM SEALER AND BURST TESTER
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.
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Not applicable.
BACKGROUND OF THE INVENTIONPackages 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.
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.
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.
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 EMBODIMENTSThis 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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Type: Application
Filed: Feb 16, 2011
Publication Date: Aug 16, 2012
Applicant: Van der Stahl Scientific, Inc. (Idyllwild, CA)
Inventor: Charlie Webb (Idyllwild, CA)
Application Number: 13/029,003
International Classification: B65B 31/06 (20060101); B65B 57/00 (20060101);