Pharmaceutical Applications: Case Studies | TM Electronics

Pharmaceutical Applications: Case Studies

Non-Destructive Vacuum Decay Chamber Testing of  Blister Packs

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 Package


 

Non-Destructive Vacuum Decay Chamber Testing of Blister Packs

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.

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Pressure Decay Leak Testing of Very Large Pouches

A 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. 

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Seal Strength and Leak Integrity Testing of Unsealed Pouches

This  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.

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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.

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Non-Destructive Pressure or Vacuum Chamber Leak Test System for Package

A  manufacturer 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.

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Pharmaceutical Applications: Case Studies | TM Electronics
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