Method And Device For Sealing Medical Packages With Integrated Real-Time Seal Integrity Vacuum Pressure Decay Testing

• US 20180328813A1
• Filed: 05/12/2017
• Published: 11/15/2018
• Est. Priority Date: 05/12/2017
• Status: Abandoned Application

• Current Assignee: Van Der Stahl Scientific, Inc.
• Original Assignee: Van Der Stahl Scientific, Inc.
• Inventors: Webb, Charles
• Application Number:
  US15/593,661
• Publication Number:
  US 20180328813A1
• Time in Patent Office: Days
• CPC Class Codes: G01M 3/34 by testing the possibility of maintaining the vacuum in containers, e.g. in can-testing machines

Abstract

The present invention relates to a device and method for inspecting and monitoring the seal integrity and/or seal strength of sterile medical packages, and more particularly, to a medical package sealer device having integrated vacuum decay or differential pressure testing allowing for real-time seal strength or integrity testing of each medical package sealed by the device. The present invention may also be described as a method for sealing and testing medical packages. By communicatively coupling the mass flow meter(s) to the processor of the herein disclosed device for sealing medical packages with integrated real-time seal integrity vacuum decay or differential pressure testing, each sealed package may be tested for a quantitative measure of air flow, and the quantitative measure of air flow may be recorded and stored in a searchable database, or used to provide a notification to an operator or to stop operation of the system. In this way, 100% of the medical packages sealed may be inspected for deviation from an established standard.

Claims

1. A device for sealing packages and testing seal integrity of sealed packages comprising:

a device housing;

a medical packaging device supported by the system housing, the medical packaging device forming a seal on one or more packages by localized heating to a temperature that melts the one or more packages;

a pressure decay leak testing apparatus for testing a seal integrity of the one or more packages;

a processor supported by the device housing and coordinating with the medical packaging device and the pressure decay leaking testing apparatus;

wherein the processor analyzes the seal integrity to ascertain whether the seal integrity satisfies a predetermined criterion.

2. The device as recited in claim 1, wherein testing a seal integrity of the one or more packages includes determining an air flow between a surrogate chamber and the one or more packages and recording the air flow for each of the one or more packages.

3. The device as recited in claim 2, wherein the processor analyzes the seal integrity to determine whether the seal integrity satisfies a predetermined criterion by comparing the air flow for each of the one or more packages to the predetermined criterion.

4. The device as recited in claim 1, wherein the medical packaging device stops operation and notifies an operator when a defective seal integrity is recognized by the processor.

5. The device as recited in claim 1, wherein the predetermined criterion is a government mandated standard.

6. The device as recited in claim 2, wherein each of the one or more packages has a package identification number and wherein the air flow for each of the one or more packages has a corresponding air flow identification number.

7. The device as recited in claim 6, wherein each of the package identification numbers and the corresponding air flow identification numbers are stored in a searchable database.

8. A method for sealing and testing medical packages, comprising the steps of:

sealing one or more packages by localized heating to a temperature that melts the one or more packages;

testing the one or more packages by pressure decay leak testing;

recording an air flow for each of the one or more packages;

comparing the air flow for each of the one or more packages to a predetermined compliance standard airflow;

indicating if one or more packages is not in compliance; and

identifying one or more non-compliance packages.

9. A device for sealing packages and testing seal integrity and seal strength of sealed packages comprising:

a device housing;

a medical packaging device supported by the system housing, the medical packaging device forming a seal on one or more packages;

a vacuum decay or pressure differential testing apparatus for testing a seal integrity and a seal strength of the one or more packages;

a processor supported by the device housing and coordinating with the medical packaging device and the vacuum decay or pressure differential testing apparatus;

wherein the processor analyzes the seal integrity and the seal strength to ascertain whether the seal integrity and seal strength satisfies a predetermined criterion.