Medical & Pharmaceutical Applications: Case Studies
Leak and Flow Testing of Multi-Lumen Catheters PDF
Flow Testing of Medical Device PDF
Non-Destructive Vacuum Decay Chamber Testing of Medical Blister Packs PDF
Pressure Decay Testing of Very Large Pouches
Seal Strength and Leak Integrity of Unsealed Pouches
Non-Destructive Pressure Decay Chamber Leak Testing of Induction Sealed Bottles
Non-Destructive Pressure or Vacuum Chamber Leak Test System for Medical Package
In-Process and Final Assembly Testing of Medical Device
Pressure Decay Leak Testing of Very Large Pouches
A medical pouch manufacturer needed to perform leak integrity testing on non-porous, flexible pouches of varying sizes, including some that are very large. Their existing test method was inefficient in that a great deal of time was needed to pressurize the larger pouches. The TME Solution Leak Tester provided is equipped with prefill to accommodate the pressure decay leak integrity testing of pouches of varying sizes. The instrument has two regulators, a built-in prefill regulator and a standard test pressure regulator. Timers are associated with each regulator's use. The instrument may be set to allow a large pouch to be filled near its final test pressure by adjusting the "Fill Regulator" pressure and the time that the regulator will supply air to the tested pouch. The standard test pressure regulator is used to set the leak test pressure.
Seal Strength and Leak Integrity Testing of Unsealed Pouches
This medical pouch manufacturer requested a system that would perform physical seal strength tests (burst, creep and creep-to-failure) on a variety of open, flexible pouches, per ISO-11607 guidelines. This package testing system is designed to test a variety of sizes of open-ended pouches. The TME BT-1000™ Automated Package Tester is designed to perform all these functions. The pneumatically operated open package fixture seals the open end while inflating the bag or pouch for testing. The Restraining Plate Fixture is designed to constrain the vertical expansion of the package under test.
Non-Destructive Pressure Decay Chamber Leak Testing of Induction Sealed Pharmaceutical Bottles
A pharmaceutical company needed a way to non-destructively test sealed pharmaceutical bottles of varying sizes that contain solid product. The TME Solution Chamber Leak Test System is designed to detect air leakage when a differential pressure is created on the bottle under test inside a closed chamber. The test fixture is composed of a fixed base with interchangeable inserts that test a variety of bottle sizes within a chamber that uses pressure to create a differential pressure on the bottle and detect leakage from the test chamber to the bottle. If air from the chamber enters the bottle a drop in chamber pressure indicates the leakage. The Solution instrument detects this leakage of air ("pressure decay"), thus indicating a leak. This test fixture is designed with automatic chamber closure and two-hand anti-tie-down safety start and release buttons.
Non-Destructive Pressure or Vacuum Chamber Leak Test System for Medical Package
A manufacturer of medical devices needed a method to non-destructively test post-sterilization thermoformed trays with a welded film cover. The customer specified that the test system must be able to perform either pressure decay or vacuum decay chamber tests at the customer's discretion and with minimum changeover time. The TME Chamber Leak Test fixture provided was designed to function for either vacuum or pressure testing. Magnetic clamps sealed the chamber for the vacuum test and additional manual clamps were provided to assure complete sealing of the test chamber during a pressure test. The TME Solution Pressure/Vacuum Chamber Leak Tester, configured to perform either vacuum or pressure decay tests, was provided. Although the system is designed to perform either a vacuum decay or a pressure decay test on the thermoformed tray, a vacuum decay test was recommended by TME for the particular package.
The test fixture is composed of a fixed base with a custom molded cavity and rubber O-ring seal to conform to the size and shape of the test item. The test is performed within a chamber that uses vacuum to create a differential pressure on the test part and detect leakage from the test part into the chamber. If air from the part enters the chamber an increase in chamber pressure indicates the leakage. The Solution tester detects this leakage of air ("vacuum decay"), thus indicating a leak.
In-Process and Final Assembly Testing of Medical Device
A medical device manufacturer needed a test system to perform an in-process leak and flow test on a small valve assembly, and then a final pre-packaging leak and flow test on the completed device consisting of the valve and a three-lumen tube assembly in which each lumen terminated with a molded flange. The valve assembly was comprised of three independent flow paths from the back to the front of the assembly through three one-way valves.
To accomplish this goal, a TME Solution Leak and Flow Test System was designed, comprised of a custom sealing fixture for leak and flow testing of the valve, a two-part custom sealing fixture for leak and flow testing the valve/lumens assembly, and a TME Solution single port Leak/Flow Tester. To test the valve, it is placed into its sealing fixture and the leak and flow test sequence is performed on each flow path. The test sequence is guided automatically by the test instrument.
To test the final assembly, two fixture parts are used to perform leak and flow tests; one secures the flange so air under pressure can be provided, and the other holds the valve assembly at the distal end. Leak and flow tests are performed on each lumen. The tests can be performed in either a leak/flow or a flow/leak sequence.
