Pharmaceutical and Medical Packaging News
Magazine
PMPN Article Index
Originally Published July 2000
PRODUCT UPDATE
Testers Verify Package Integrity
Multifunction instruments perform a variety of tests.
A helium leak detector offers features that make it easy to use. The versatile ASM 142 universal leak tester includes a 7–cu ft/min roughing pump, voice synthesization, and the ability to remember commands. Crossover to the leak detection pressure is 7.5 Torr. The high-sensitivity instrument can measure to 10–11 atm/cm3/sec. Alcatel Vacuum Technology Inc., Hingham, MA.
Adhesion and interface bond quality can be checked with a nondestructive tester. The C-Mode Scanning Acoustic Microscope (C-SAM) allows for 100% nondestructive inspection of medical device and pharmaceutical packaging seals. The technology uses high-frequency ultrasound to image a wide variety of material defects including voids, delaminations, channel opens, variations in seal width, and containment within the seal area. The technology can be applied to a wide variety of materials and packaging types including single or multilaminate films (both foil and polymer) as well as formed or molded plastic cassettes and devices. Sonoscan Inc., Elk Grove Village, IL.
A digital bottle-cap torque tester can be used to check that the application and removal torques of bottle caps meet requirements. The sensor includes a universal gripping mechanism that accommodates a wide range of round or irregularly shaped items. The splashproof Model STB can also be used to measure breakaway-fastener torque, motor-stall torque, and valve-operating torque and to calibrate torque tools. As part of a complete system with the Model BGI digital force and torque indicator, the unit features a multifunction set of 4½-character LCD annunciators, peak-torque memory for clockwise and counterclockwise directions, selectable analog and digital filtering, and bidirectional RS-232 communications. Mark-10 Corp., Hicksville, NY.
An automated package tester is able to perform both leak-integrity tests and a battery of seal-strength tests on medical device and pharmaceutical packages. Foil, laminate, and barrier packaging materials are well suited for the burst, creep, and creep-to-failure seal-strength tests, as are porous pouches, trays, and blisters with materials such as Tyvek and paper barriers. The Model BT-1000 tester features eight test modes for conducting both types of testing on the same nonporous package without having to change the setup, test item, or instrument settings. A user-friendly menu and system memory make program setup simple. Graphical results of individual tests and statistical quality control analysis of as many as 1000 tests in the data log optimize process control. T.M. Electronics Inc., Tacoma, WA.
Automated leak testers using helium mass-spectrometric sensing can measure leakage rates as low as 0.000001 standard cm3/sec. The helium method is useful for testing critical sealed product enclosures or packaging that cannot be pressurized internally or otherwise accessed to measure pressure change. The test part is placed first in a pressurized helium environment and then in a vacuum environment where seepage of helium molecules can be detected. Test data are displayed or else recalled for later printing or downloading. The instrument can perform statistical calculations from stored data to show the mean, standard deviation, and mean plus or minus standard deviation. InterTech Development Co., Skokie, IL.
A self-teaching leak tester can detect leak sources as small as 0.5 µm in pharmaceutical blisters, vials, and ampules and in IV bags. The validatable, nondestructive Series PH-325 tester uses a high-resolution differential vacuum transducer as well as an absolute vacuum transducer, monitoring the test vacuum and differential vacuum every 100 ms. The tester offers test sensitivity down to 10–5 Pa/m3/sec. System accuracy and precision are maintained even at the highest performance levels. Its operator touch screen interface and self-teaching capability make the user-friendly inspection system easy to set up and adjust. Packaging Technologies & Inspection, Tuckahoe, NY.
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