Pharmaceutical Applications: Case Studies
A medical device company manufactures a variety of catheter configurations for which they require high-resolution, accurate, repeatable and reliable leak and flow test results. The test must be performed on each lumen of the catheter and the results reported by lumen. In addition, the test instrument must have the flexibility to create separate pass/fail criteria for various lumens, and to accommodate both female luer inputs and straight tube inputs.
For this customer, TME designed a unique instrument that met all the criteria needed. The Seven Port Sequential TME Solution™ is a customized instrument that may be programmed to test from one to seven ports operating in a sequential process. This enables the instrument to test up to seven lumens on a single catheter. Each channel may be selected to run either leak alone, flow alone or flow followed by leak tests. When flow tests are selected all flow tests are performed prior to running any leak tests.
All leak or flow testing pressure and time parameters must be the same for all ports in use, but decay limits and flow limit parameters for each port may be customized to create separate pass/fail criteria for various lumens. Used with a Sealing Fixture to accept the distal end of the catheter, this Solution is configured to accept up to four (4) female luer inputs and up to three (3) straight tubes. Test data are presented in a listed display where decay pressure and flow results are shown.
A company that manufactures a variety of tube assembly configurations needed a precise method for performing a flow test that would be adaptable to various barrel diameters and lengths. This flow test system consists of a TME Solution Flow Tester and associated test fixture. This Solution contains an internal electronic regulator with an external remote transducer to provide pressure control for the flow test. The fixture enables flow testing of the complete tube assembly. The fixture is comprised of three interchangeable radial sealing assemblies designed to accommodate varying tube diameters. The radial sealing assembly position is adjustable to accommodate varying lengths of assemblies. The fixture also contains a fixed-location cradle with two seat sizes to accommodate varying barrel diameters. The tube assembly is placed in the cradle and upon initiation of the test, a seal closes securely around the tube and the assembly is pressurized. Flow measurements will indicate the rate at which air escapes from the complete assembly.
The customer was looking for a method to confirm the leak integrity of medical dispenser blister packs without destroying the package and/or contaminating the contents. A vacuum decay chamber test system was recommended, as it can be further customized to accommodate various configurations of blister packs. The test fixture is composed of a fixed base with inserts designed to minimize the "interstitial space" outside the test part, thus maximizing the sensitivity of the test. The blisters are tested within a chamber that uses vacuum to create a differential pressure on the package and detect leakage from the "head space" (air space surrounding the product inside the blister) of the test part into the chamber. If air from the part enters the chamber a reduced vacuum level indicates a leakage into the test chamber. The Solution Leak Tester detects this leakage of air ("vacuum decay"), thus indicating a leak. If the part is not identified as a reject, it is returned to the packaging line as good product.
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.
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.
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.
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.
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.