Trusting Leak Testers

A variety of testers help engineers ensure package integrity.

Once a package is designed and filled, the hardest part of a package engineer's job begins. He or she must ensure that the package retains its integrity throughout handling, shipping, and storage. Engineers must subject the packaged product to a variety of tests to make sure there are no elusive pinholes, tears, or incomplete seals that could threaten the sterility of the product.

To aid engineers in this endeavor, equipment suppliers offer a variety of units that test for leaks or bursts in a variety of different ways. Some use water, others vacuum, but the end result is the same—to locate problematic packages and help engineers identify the cause of the fault.

A burst tester evaluates packages in accordance with ASTM's standard test method F 1140-88. The tester features an adjustable control for positive pressure input and a foot-operated pedal clamp for quick, hands-free package placement into the inflation port. An oversized pressure gage monitors burst pressure, and an air-pressure regulator adjusts input pressure. Kenpak, City of Commerce, CA.

An instrument performs electronic, dry-air leak testing at production-line speeds. The M-1045 tester requires no operator judgment, and reports results on an easy-to-read vacuum fluorescent display, showing real-time pressure changes, pressure drops because of leaks, date and time of test, and type of fault. The unit can automatically convert pressure drop data to a leak rate in standard cubic centimeters per minute. It remembers up to 99 test programs and can display, print, or download data from the last 100 tests. InterTech Development Co., Skokie, IL.

A multicavity test system performs external and inner wall leak tests on medical and pharmaceutical packages. The Sprint-1100 package tester can also handle plastics and foils that hold liquids and powders. In a multicavity package test, each cavity is individually tested. Packaging is placed in a vacuum chamber that performs a gross leak test. The system uses strain gages to detect small leaks in minimal test cycles. As many as 10 test programs can be stored. Uson, Houston, TX.

A package-testing system performs objective, reliable, repeatable, and nondestructive evaluations of medical device packaging made of porous, gas-permeable membranes. Applicable packaging includes thermoformed trays with porous lids and flexible pouches with at least one porous side. SealCheck 210 can detect leaks across the seal as small as 0.001 to 0.002 in. in diam. The unit provides retrievable validation data. True Technology Inc., Newton, MA.

A tester verifies the integrity of nonporous packages used for medical or pharmaceutical products. The Test-A-Pack F100-2700-2 consists of a digital control console and a package test chamber. When water is added to the test chamber for submersion testing, the exact location of any package leak can be seen as a stream of bubbles. The control console automatically regulates the vacuum source while displaying test data in inches or millimeters of mercury. The date, time, machine settings, and test results can be automatically printed out using an optional printer. Carleton Technologies Inc., Orchard Park, NY.

A portable, compact, pressure-decay leak tester can hold up to eight tests in its memory and displays test results in green and red. The Mediteq performs burst, passage blockage, and pressure hold tests on bags, tubing, sealed packages, and other items. An RS-232 interface allows the system to interact with a computer; it can link several tests together for performing multiple tests on one product. Ateq Corp., Canton, MI.

An automated system combines integrity leak tests with seal strength tests such as burst, creep, or creep-to-failure tests for evaluating film, foil, laminate, or porous barrier package materials used in the medical device or pharmaceutical industry. The Model BT-1000 automated tester has eight test modes that run programs in one set-up without changing instrument settings. Graphic pressure plot results of each test are shown on a LCD. Eight screens of data display SQC charts and a histogram from a the 1000-result data log. Results can be downloaded via an RS-232 port. T.M. Electronics Inc., Worcester, MA.

An automatic argon console leak detector uses a dual-sector mass spectrometer tube to test products that are too permeable for helium testing. The MS-50 features automatic calibration checking and tuning, 50 programmable test recipes, a resolution of 40 at mass 40 (argon), and an internal temperature–compensated argon-calibrated leak standard traceable to NIST. It can test for leaks in less than three minutes. Veeco Instruments Inc., Plainview, NY.

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