Load and Unload are the times it takes to engage and disengage your part or package from the pressurizing and pressure decay measuring instrument. Although not technically part of the actual test cycle time, these periods must be taken into account in order to realistically project the time needed to test individual items. Charge is the period of time in which the part is being pressurized to the predetermined test pressure (or slightly above this pressure, so any stability changes can be taken into account). Settle is the period allowed for the volume of the pressurized part or package to change and stabilize due to the stresses introduced by pressurization. This is particularly crucial in the case of flexible materials whose volume may change substantially with pressurization. If this is an issue for your product, you will want to review the discussion on restraining plate fixtures in a later unit of this course. The Settle period also allows time for the adiabatic temperature rise (the heat generated through compression of a gas) to stabilize. Test is the data taking period in which the measurement of the decay of pressure is taken.

In the pressure decay leak test illustrated above, the graph of the drop in pressure (Y axis) over time (x axis) is called the decay curve. TME uses the decay curve in its "Test Plot" graphic display and in its "Memory Reference Curve" technology, in which the decay curve for an acceptable test part is determined and reject decisions are made by the test instrument by comparing the test decay curve to the acceptable "memory reference curve" for the test part.

Mass Flow Testing for Leakage and Obstructions

Mass flow testing uses intrinsic properties of air to directly measure the amount of air escaping a closed system. While pressure decay testing is often the method of choice for leak testing, mass flow testing has several advantages, including speed of test (1-2 seconds, rather than the longer time required for the pressure decay cycle described above). In addition the mass flow test is not dependent on temperature or air density, which may be a difficulty for the pressure decay test.

Mass flow testing is a better choice for identifying obstructions in an open-ended test part. Unlike mass flow testing for leakage, mass flow testing for obstructions uses a continual flow model to calculate the blockage in an open-ended device, such as a medical catheter or refrigeration tubing. Any obstructions in the part will restrict the flow of air through the device, thereby causing the part to fail the test. TME leak and flow testers can be programmed to perform both a pressure decay leak test and a flow test consecutively on a test part, confirming that the part has neither leaks nor obstructions.

Other types of occlusion testing include measurement of back pressure or pressure drop.

Statistical Procedures on Pressure Decay Test Results

Pressure decay testing provides test results that are quantifiable, variable statistical data. Quantification of information allows the data obtained in the tests to be used in several ways, including:

1. Documentation that your product meets the required specifications for leakage;
   
2. Validation of your testing protocol, particularly important in the medical device manufacturing/packaging industry;
   
3. Process control.

Control charts are commonly used to aid in manufacturing process control. The objective of control charts is to monitor the process in real time so if something goes wrong, it can be noted and corrected with the minimum of lost product. With regard to a manufactured product you are performing a pressure decay leak test on, for example, the concept behind control charts is as follows:

1. A manufacturing process "in control" will result in end-of-test pressure decay values that fall consistently in a predictable range around the average. In addition, the average value will not change appreciably over time when the process is "in control".
   
2. A single end-of-test pressure decay value is referred to as "x". The average of values over a period of time is referred to as the mean, or "X-bar". The range of t test values is the difference between the maximum and the minimum values.
   
3. Because processes always vary slightly due to manufacturing and material variations, "good" product test values will go up and down within a range around the mean value. That range can be statistically predicted using the mean test value plus and minus three standard deviations (a measure of the variation inherent in the process). The "acceptable" range is the set of pressure decay end-of-test values that fall between the upper and lower control limits. These control limits are automatically calculated in the TME test instrument from the previous test results in the Datalog.
   
4. The data points on the control chart consist of subgroups of test results. These subgroups can be as small as two tests, or as many as 20 tests. Subgroups are used to minimize the effect of a testing error or a single bad part.

Control charts for the mean (X-bar) can help the manufacturer in several ways:

1. If, for example, a temperature problem in the manufacturing equipment is causing weaker than usual closures, the downward trend in pressure decay test values will be obvious on the control chart even before the product reaches the point of failures. This gives the machine operator an opportunity to correct the temperature problem with little or no loss of product.
   
2. Several data points outside of the control limits may give the machine operator an indication that an instability is developing in the process that needs to be investigated before a large quantity of bad product is produced.

Control charts for range (the difference between the maximum burst value and the minimum burst value within a subgroup) also have a place in identifying when the manufacturing process is becoming erratic and inconsistent.

Calibration vs. Decay Measurements in Pressure Decay Leak Testers

The question has been raised as to the relationship between "calibration" (accuracy of the pressure decay leak tester) and "resolution" (ability of the tester to detect a pressure difference - "decay" - that occurs during the leak test. Specifically, confusion exists regarding how the "resolution" of the leak test system can be 0.0001 psi, even though the accuracy of the instrument's "calibration" (accuracy) may be significantly greater, such as +/- 0.075 psi. The answer to the question lies in the definition of these two parameters of pressure decay leak testers, and the understanding of what is happening during a pressure decay leak test.

Determination of leaks in a device using the "pressure decay" method involves pressurizing the device to a predetermined pressure, locking out the supply source of the pressure and sensing a pressure change ("decay") during a predetermined test time. Modern pressure decay measuring instruments such as the TM Electronics Solution Leak Tester are capable of detecting pressure changes as small as 0.0001 psi. This ability to detect pressure change during the test time is defined as the instrument's "resolution". This is not related to the starting pressure of the test (except for the special circumstance in which specified leakage rate is used as the test criterion).

Calibration, on the other hand, refers to the accuracy of the leak tester's reproduction of the desired test pressure for the leak test. For example, if you are performing a pressure decay leak test using 50 psi as your test pressure, accurate calibration ensures that your test instrument will consistently reproduce that test pressure, in a specific set of units of measure, in a standard set of conditions, every time you test, within a range of variation that is defined by instrument accuracy. TM Electronics leak test instruments are calibrated with reference to a known "standard" gauge, controlled by a standards body such as National Institute of Standards Technology (NIST).

To summarize, the resolution of the leak test system is defined by the smallest pressure difference (decay) the instrument can consistently detect during a predetermined test time, regardless of the starting pressure of the leak test. The calibration of the instrument is defined as the accuracy of the test pressure applied at the beginning of the leak test. For all practical purposes, these two items are not related, but totally separate characteristics of the leak test instrument.

APPENDIX A: A Survey of Applications for the TME Pressure/Vacuum Decay Leak Testers

Automotive Components Industry:
This TME Solution Leak Test System is designed to perform two pressure decay leak tests in sequence at two different pressures on an electronic connector housing. The system is comprised of a one-port TME Solution Leak Tester and a custom test fixture with their associated air and sensor lines. When a test item is properly placed into the test fixture, the system will automatically perform a leak test of the connector cavity with the part small bottom vent membrane sealed closed, and then a second lower pressure decay test is LINKED to the original test. The lower pressure test will test the part with the vent membrane open to atmosphere.

Medical Device Industry: Testing Multi-Lumen Catheters
This system consists of a pneumatically actuated radial sealing fixture fixture comprised of three pneumatic seal clamps. The seal clamps are intended to close around the outside diameter of the catheter and seal any leak paths from the catheter distal tip and proximal side ports during pressure decay leak. The seal clamps can have their individual positions adjusted along the length of the catheter to seal the side ports. The individual seal clamps, labeled Seal 1, Seal 2 and Seal 3, can be individually actuated in any order using the "Ports and Seals" menu. The Radial Sealing Fixture is customized to accommodate several catheter lengths.

Industrial Products Industry:

Food Industry:
The customer produces thermoformed trays that will hold food products. The need was to confirm the package quality after thermoforming, and to detect any cracks, holes or defects in the tray before filling. The empty tray fits over a raised rectangle on the fixture base and the edges are sealed to the fixture by means of manual clamps. A direct leak test is then performed by introducing pressure through the raised rectangle into the air space inside the tray. The purpose of the raised rectangle onto which the tray is fitted is to minimize the air space to pressurize, thus increasing the sensitivity and shortening the time for the test. This fixture could be customized to be applicable to any rigid, non-porous package form or product that can be sealed to the flat surface of the fixture.

APPENDIX B: Technical Help - Relationship between Altitude and Pressure